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University of Groningen Immediate dental implant placement in the aesthetic zone Slagter, Kirsten Willemijn IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2016 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Slagter, K. W. (2016). Immediate dental implant placement in the aesthetic zone. [Groningen]: Rijksuniversiteit Groningen. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 02-06-2020

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Page 1: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

University of Groningen

Immediate dental implant placement in the aesthetic zoneSlagter, Kirsten Willemijn

IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.

Document VersionPublisher's PDF, also known as Version of record

Publication date:2016

Link to publication in University of Groningen/UMCG research database

Citation for published version (APA):Slagter, K. W. (2016). Immediate dental implant placement in the aesthetic zone. [Groningen]:Rijksuniversiteit Groningen.

CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).

Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.

Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.

Download date: 02-06-2020

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Immediate dental implant placement

in the aesthetic zone

Kirsten Slagter

Thesis

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The research presented in this thesis was performed at the Department of Oral and

Maxillofacial Surgery, University Medical Center Groningen, The Netherlands.

This research project was supported by:

Nobel Biocare Services AG, Zurich, Switzerland (materials grant: 2009-851)

Nobel Biocare c/o Medicim NV, Mechelen, Belgium

Publication of this thesis was supported by:

Buijs Tandartsen (www.buijstandartsen.nl)

DENK RUIM OVER INTERIEUR (www.denkruim.nl)

Dental Clinics (www.dentalclinics.nl)

Gjald Accountancy en AFAS Dienstverlening (www.gjald.nl)

Gronings Tandtechnisch Laboratorium (www.gtl.nl)

Koninklijke Nederlandse Maatschappij tot bevordering der Tandheelkunde (www.knmt.nl)

Nobel Biocare Nederland BV (www.nobelbiocare.nl)

Nederlandse Vereniging voor Mondziekten, Kaak- en Aangezichtschirurgie (www.nvmka.nl)

Nederlandse Vereniging voor Orale Implantologie (www.nvoi.nl)

Tandartspraktijk Reijenburg (H.H. Slagter, de Reijenburg 31 te Veldhoven)

Tandprothetische Praktijk Wietse Molenaar (www.wietsemolenaar.nl)

Zheng (Zheng, Stoeldraaierstraat 11 te Groningen)

University of Groningen (www.rug.nl)

Bookdesign: Sythe Veenje, Buro.Baum

Printed by: Drukkerij van der Eems, Heerenveen

ISBN: 978-90-367-8725-3

ISBN e-pub: 978-90-367-8724-6

© Kirsten Slagter, 2016

All rights reserved. No part of this publication may be reported or transmitted, in any form or

by any means, without prior permission of the author.

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Immediate dental implant placement in the aesthetic zone

Proefschrift

ter verkrijging van de graad van doctor aan deRijksuniversiteit Groningen

op gezag van derector magnificus prof. dr. E. Sterken

en volgens besluit van het College voor Promoties.

De openbare verdediging zal plaatsvinden op

woensdag 6 april 2016 om 16.15 uur

door

Kirsten Willemijn Slagter

geboren op 3 juli 1983

te Utrecht

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Promotores Prof. dr. G.M. Raghoebar

Prof. dr. H.J.A. Meijer

Prof. dr. A. Vissink

BeoordelingscommissieProf. dr. M.S. Cune

Prof. dr. G.J. Meijer

Prof. dr. E.B. Wolvius

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ParanimfenDr. N.A. Bakker

Dr. Y.C.M. de Waal

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1General introduction

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General Introduction

Failing or missing teeth in the aesthetic zone require a predictable treatment strategy1. Single-tooth dental

implant placement in the aesthetic zone is a highly reliable treatment option for replacing a failing tooth or

missing tooth.2,3 There is a growing tendency in this zone to place single-tooth dental implants immediately

after extraction of a failing tooth in the fresh extraction socket4, 5 as an alternative to early (<8 weeks after

tooth extraction) or delayed placed implants (>8 weeks after tooth extraction). Presumably, this tendency

is related to evolving society factors, with more demanding patients and a wish for direct and better

aesthetic results. Innovations in implant surfaces and designs have facilitated the possibilities for such

an approach.6 There is insufficient evidence, however, which approach immediate, early or delayed placed

dental implants, are in favour for which specific treatment strategy in the aesthetic zone.7

The presence of sufficient bone volume is the most important prerequisite to achieve primary stability

of the dental implant, especially in case of immediate implant placement in an extraction socket. 1 A

successful aesthetic outcome is suggested to be dependent on establishment of an optimal three-

dimensional implant position within the available bone dimensions and the maintenance of adequate

buccal bone along the implant axis.8,9 The size of the bony defect after extraction can be a considerable

aesthetic risk for immediately placed implants. The combination of buccal extraction socket defects

and thin overlying soft tissues is a considerable aesthetic risk for maintaining an acceptable long-term

aesthetic outcome for immediately placed implants, despite ideal placement and synchronous hard or

soft tissue grafting procedures.10 A delayed approach with hard or soft tissue grafting in the event of an

osseous defect presenting on the labial bony plate was therefore recommended. Recently, due to altering

techniques, a favourable treatment outcome of immediate implant placement in extraction sockets

with labial plate dehiscences was reported.11-13 This means that an intact buccal plate is not essential for

immediate implant placement. To what extent the bony defect affects the treatment outcome remains

unclear.

Regarding replacing a missing tooth (delayed implant placement), immediate provisionalization (<24

hours after implant placement) is not less favourable than conventional provisionalization for single-

tooth implants.14 For a failing tooth (immediate implant placement), it is assumed that immediate

provisionalization results in better aesthetice results compared to conventional provisionalization.4, 5

However, the exact effect of immediate provisionalization combined with immediate implant placement

requires further research.

There are several outcome measures to assess the treatment outcome of single-tooth dental implants.

The outcome measure implant survival seems to be hardly affected by timing of implant placement relative

to tooth extraction.3 Thus, as timing of implant placement seems not to be a major factor determining

implant survival, the focus in outcome measures shifted towards the dynamics of hard and soft peri-

implant tissues. Establishment and maintenance of healthy hard and soft peri-implant tissues are crucial,

particularly in the aesthetic zone. 15-18

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Peri-implant bone preservation is thought to be a key factor determining the outcome of peri-implant

hard tissues as Marginal Bone level (MBL) and amount of Buccal Bone Thickness (BBT).19 MBL can be

detected with a standardized method on conventional radiographs.20 The lack of data regarding BBT is

probably related to frequently encountered difficulties in standardization of the measurements. Cone-

beam computed tomography (CBCT) has proven to be a useful tool that has been successfully employed

for various dental procedures.21 The availability of an accurate and reliable imaging modality is clinically

important in terms of postoperative monitoring of bone volume stability and assessing the best treatment

approach.22 For example, to assess the minimum BBT at time of implant placement to predict the aesthetic

outcome and the long-term stability.19,23,24

Besides peri-implant hard tissues, the outcome of peri-implant soft tissues are essential in the aesthetic

zone. It is suggested that timing of implant placement and provisionalization affects peri-implant soft

tissues16,25 by increasing a risk for recession and thereby influence the aesthetic and patient-centered

outcome. The aesthetic result is mainly determined by the shape of healthy pink soft peri-implant tissues

and the contour and colour of the definitive crown. Therefore several aesthetic indexes (e.g. ICAI26 and PES/

WES27) have been developed to objectify the aesthetic outcome. Patient-centered outcomes are outcomes

that are based on the care experience viewed through the eyes of patients and focus on outcomes

important to patients such as quality of life. For patient-centered outcomes, Visual Analogue Scales

(VAS)28 and the Oral Health Impact Profile (OHIP)29 are commonly applied. For immediate dental implant

placement in the aesthetic zone, no randomized clinical trials depending on the size of the bony defect

after extraction, assessing the full panel of outcome measures, including changes in the hard and soft

tissue dimensions, implant survival, aesthetic evaluation and patient-centered outcome in the aesthetic

zone, have been published yet.

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General aim and outline of the thesis

The general aim of the research described in this thesis was to assess the 1-year treatment outcome

of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of

changes in hard and soft tissue dimensions, implant survival, aesthetic evaluation and patient-centered

outcome.

The specific aims were:

- a systematic review on the currently available literature assessing implant survival, peri-implant

hard and soft tissues, aesthetic outcome and patient-centered outcomes in the aesthetic zone after

immediate placement of dental implants;

- to perform a randomized controlled trial to assess whether the 1-year outcome of immediate dental

implant placement and immediate provisionalization was non-inferior to immediate dental implant

placement and delayed provisionalization in extraction sockets with labial bony defects of <5 mm;

- to perform a randomized controlled trial to assess whether the 1-year outcome of immediate dental

implant placement and delayed provisionalization is non-inferior to delayed dental implant placement

and delayed provisionalization in extraction sockets with labial bony defects of ≥5 mm;

- to develop a reproducible method based on 3D image diagnostic and treatment planning software

programs for buccal bone measurements at dental implants on CBCTs;

- to assess the amount of BBT of immediate and delayed placed dental implants in the aesthetic zone.

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References

1. Kan JY, Rungcharassaeng K. Site development for

anterior single implant esthetics: the dentulous site.

Compend Contin Educ Dent 2001;22(3):221-6, 228,

230-1.

2. Esposito M, Grusovin MG, Polyzos IP, Felice P,

Worthington HV. Timing of implant placement after

tooth extraction: immediate, immediate-delayed or

delayed implants? A Cochrane systematic review. Eur J

Oral Implantol 2010;3(3):189-205.

3. Lang NP, Pun L, Lau KY, Li KY, Wong MC. A

systematic review on survival and success rates of

implants placed immediately into fresh extraction

sockets after at least 1 year. Clin Oral Implants Res

2012;23 Suppl 5:39-66.

4. De Rouck T, Collys K, Cosyn J. Single-tooth replacement

in the anterior maxilla by means of immediate

implantation and provisionalization: a review. Int J

Oral Maxillofac Implants 2008;23(5):897-904.

5. Slagter KW, den Hartog L, Bakker NA, Vissink A, Meijer

HJ, Raghoebar GM. Immediate placement of dental

implants in the esthetic zone: a systematic review and

pooled analysis. J Periodontol 2014;85(7):e241-50.

6. Eghbali A, De Bruyn H, De Rouck T, Cleymaet R, Wyn

I, Cosyn J. Single implant treatment in healing versus

healed sites of the anterior maxilla: a clinical and

radiographic evaluation. Clin Implant Dent Relat Res

2012;14(3):336-346.

7. Esposito M, Grusovin MG, Polyzos IP, Felice P,

Worthington HV. Interventions for replacing missing

teeth: dental implants in fresh extraction sockets

(immediate, immediate-delayed and delayed

implants). Cochrane Database Syst Rev 2010;(9)

(9):CD005968.

8. Buser D, Martin W, Belser UC. Optimizing esthetics for

implant restorations in the anterior maxilla: anatomic

and surgical considerations. Int J Oral Maxillofac

Implants 2004;19 Suppl:43-61.

9. Grunder U, Gracis S, Capelli M. Influence gingival

dynamics after immediate tooth replacement and

guided bone regeneration: 1-year results. J Oral

Maxillofac Surg 2007;65(7 Suppl 1):13-19.

10. Kan JY, Rungcharassaeng K, Sclar A, LozadaJL.Effects

of the facial osseous defect morphology on gingival

dynamics after immediate tooth replacement and

guided bone regeneration: 1-year results. J Oral

Maxillofac Surg 2007;65(7 Suppl 1):13-19.

11. Noelken R, Kunkel M, Wagner W. Immediate implant

placement and provisionalization after long-axis root

fracture and complete loss of the facial bony lamella.

Int J Periodontics Restorative Dent 2011;31(2):175-183.

12. da Rosa JC, Rosa AC, da Rosa DM, Zardo CM.

Immediate Dentoalveolar Restoration of compromised

sockets: a novel technique. Eur J Esthet Dent

2013;8(3):432-443.

13. Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL,

Tarnow DP. Immediate Implant Placement into

Extraction Sockets with Labial Plate Dehiscence

Defects: A Clinical Case Series. Clin Implant Dent Relat

Res 2015; Apr 27. [Epub ahead of print]

14. den Hartog L, Raghoebar GM, Stellingsma K, Vissink

A, Meijer HJ. Immediate non-occlusal loading of single

implants in the aesthetic zone: a randomized clinical

trial. J Clin Periodontol 2011;38(2):186-194.

15. den Hartog L, Slater JJ, Vissink A, Meijer HJ, Raghoebar

GM. Treatment outcome of immediate, early and

conventional single-tooth implants in the aesthetic

zone: a systematic review to survival, bone level,

soft-tissue, aesthetics and patient satisfaction. J Clin

Periodontol 2008;35(12):1073-1086.

16. Cosyn J, Hooghe N, De Bruyn H. A systematic review

on the frequency of advanced recession following

single immediate implant treatment. J Clin Periodontol

2012;39(6):582-589.

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17. Jung RE, Zembic A, Pjetursson BE, Zwahlen M, Thoma

DS. Systematic review of the survival rate and the

incidence of biological, technical, and aesthetic

complications of single crowns on implants eported in

longitudinal studies with a mean follow-up

of 5 years. Clin Oral Implants Res 2012;23 Suppl

6:2-

18. Hammerle CH, Araujo MG, Simion M, Osteology

Consensus Group 2011. Evidence-based knowledge on

the biology and treatment of extraction sockets. Clin

Oral Implants Res 2012;23 Suppl 5:80-82.

19. Merheb J, Quirynen M, Teughels W. Critical buccal

bone dimensions along implants. Periodontol 2000

2014;66(1):97-105.

20. Meijndert L, Meijer HJ, Raghoebar GM, Vissink A. A

technique for standardized evaluation of soft and hard

peri-implant tissues in partially edentulous patients. J

Periodontol 2004;75(5):646-651.

21. Sennerby L, Andersson P, Pagliani L, et al. Evaluation

of a Novel Cone Beam Computed Tomography Scanner

for Bone Density Examinations in Preoperative 3D

Reconstructions and Correlation with Primary Implant

Stability. Clin Implant Dent Relat Res 2015;17(5):844-

53.

22. El Nahass H, Naiem SN. Analysis of the dimensions

of the labial bone wall in the anterior maxilla: a cone-

beam computed tomography study. Clin Oral Implants

Res 2015;26(4):e57-61.

23. Klinge B, Flemmig TF, Working Group 3. Tissue

augmentation and esthetics (Working Group 3). Clin

Oral Implants Res 2009;20 Suppl 4:166-170.

24. Teughels W, Merheb J, Quirynen M. Critical horizontal

dimensions of interproximal and buccal bone around

implants for optimal aesthetic outcomes: a systematic

review. Clin Oral Implants Res 2009;20 Suppl 4:134-

145.

25. Lin GH, Chan HL, Wang HL. The Effect of Currently

Available Surgical and Restorative Interventions on

Reducing Mid-facial Mucosal Recession of Single-

Tooth Immediate Placed Implants: A Systematic

Review. J Periodontol 2014;85(1):92-102.

26. Meijer HJ, Stellingsma K, Meijndert L, Raghoebar GM.

A new index for rating aesthetics of implant-supported

single crowns and adjacent soft tissues--the Implant

Crown Aesthetic Index. Clin Oral Implants Res

2005;16(6):645-649.

27. Belser UC, Grutter L, Vailati F, Bornstein MM Weber HP,

Buser D. Outcome evaluation of early placed maxillary

anterior single-tooth implants using objective esthetic

criteria: a cross-sectional, retrospective study in 45

patients with a 2- to 4-year follow-up using pink and

white esthetic scores. J Periodontol 2009;80(1):140-

151.

28. Gallagher EJ, Liebman M, Bijur PE. Prospective

validation of clinically important changes in pain

severity measured on a visual analog scale. Ann

Emerg Med 2001;38(6):633-638.

29. van der Meulen MJ, John MT, Naeije M, Lobbezoo F.

Developing abbreviated OHIP versions for use with

TMD patients. J Oral Rehabil 2012;39(1):18-27.

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2Immediate placement of dental

implants in the aesthetic zone:

a systematic review and pooled analysis.

This chapter is an edited version of the manuscript:Slagter KW, den Hartog L, Bakker NA, Vissink A, Meij er HJ, Raghoebar GM.

Immediate placement of dental implants in the esthetic zone: a systematic review and pooled analysis. J Periodontol 2014;85:e241-50.

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Abstract

Background:

Research interest on immediate placement of dental implants has shifted from

implant survival towards optimal preservation of soft and hard tissues. The aim was to

systematically assess the condition of implant survival, peri-implant hard and soft tissue

changes, aesthetic outcome and patient satisfaction of immediately placed single-tooth

implants in the aesthetic zone.

Material and methods:

MEDLINE, EMBASE and CENTRAL databases were searched for publications up to June

2013. Studies reporting on implant survival, changes in hard and soft peri-implant tissues,

aesthetic outcome and patient satisfaction were considered. A pooled analysis was

performed to identify factors associated with survival and peri-implant tissue changes

after immediate implant placement.

Results:

34 studies were considered eligible. Immediate placement of single tooth implants in

the aesthetic zone was accompanied by excellent one year implant survival (97.1%,

95% Confidence Interval (CI) 0.958-0.980). Mean marginal peri-implant bone loss was

0.81±0.48 mm, mean loss of interproximal peri-implant mucosa level was 0.38±0.23 mm

and mean loss of peri-implant midfacial mucosa level was 0.54±0.39 mm. Regression

analysis revealed that delayed provisionalization (OR 60.22, 95%CI 8.36-434.04, p<0.001),

use of a flap (OR 20.34, 95%CI 10.52 -39.65, p<0.001) and use of a connective tissue graft

(OR 4.56, 95%CI 1.72-12.08, p< 0.001) were associated with marginal peri-implant bone

level change >0.50 mm. Due to underreporting, aesthetic and patient satisfaction did not

allow for reliable analysis.

Conclusion:

Immediate placement with immediate provisionalization of dental implants in the

aesthetic zone results in excellent short-term treatment outcome in terms of implant

survival, and minimal change of peri-implant soft and hard tissue dimensions.

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Introduction

Single-tooth implant placement in the aesthetic zone is a highly reliable treatment option for replacing a

failing tooth.1-3 Yet, the research interest has shifted from implant survival towards optimal preservation of

soft and hard peri-implant tissues.3,4 Moreover, attention has shifted to aesthetic outcomes and patient-

centered outcomes of single-tooth implant placement..5-7

The aesthetic outcome is determined to a large extent by healthy and stable peri-implant tissues as well

as the implant crown. Several aesthetic indexes, such as the Implant Crown Aesthetic Index (ICAI)6, the

pink esthetic score (PES) and the white esthetic score (WES)7 have been developed in order to objectify the

aesthetic outcome, while for patient-centered outcomes, the Oral Health Impact Profile (OHlP)5 has been

developed. There is a growing tendency to place implants immediately after extraction often combined

with immediate provisionalization.2 This tendency is probably amongst others a result of evolving society

factors, more demanding patients and the wish for quick results. However, it is suggested that timing

of implant placement and timing of provisionalization influences peri-implant soft and hard tissues8-11

thus challenging the aesthetic and patient-centered outcome. According to some recent studies, implant

survival seems to be hardly affected by timing of implant placement relative to tooth extraction.1-3

In terms of hard and soft tissue changes, no definitive conclusions have been drawn from the available

literature so far. However, the focus of recent systematic reviews is on specific aspects of peri-implant

tissues after immediate implant placement. E.g., in the study by Lang et al.12, implant survival and success

rates were the only parameters measured, while in the studies of Lin et al.13 and Cosyn et al.9 only recession

of soft tissues was observed.

A systemic review of all identified variables affecting the treatment outcome of immediate implant

placement is to the best of our knowledge not available in the international literature. Therefore, the aim of

the present study was to perform a systematic review on the currently available literature assessing implant

survival, peri-implant hard and soft tissues, aesthetic outcome and patient outcomes in the aesthetic zone

after immediate placement of endosseous dental implants. In addition, a pooled analysis of the included

studies was performed to identify factors possibly associated with the aforementioned outcome variables.

Material and methods

Search strategy

Three electronic databases were considered by two reviewers (K.S. and L.H.): MEDLINE (PubMed), CENTRAL

(Cochrane Central Register of Controlled Trials) and EMBASE. No language restriction was applied.

Databases were scrutinized for studies published up to the 1st of June 2013. The search strategy is outlined

in Table 1.

Study selection

Titles and abstracts of the identified publications were screened. Full-text articles were obtained for all

potentially relevant studies and eligibility assessment was performed by two independent reviewers

(K.S. and L.H.). In addition, references of the selected publications and previously published reviews

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relevant to the present review were searched for eligible studies. In case of disagreement between the

two reviewers, consensus was reached by discussion with the senior author (G.R.). To ensure that no

patients were analyzed twice in the pooled analysis, studies in which the same patients were analyzed with

different follow-ups, leading to different publications, the study with the longest follow-up was selected for

definitive analysis.

Inclusion criteria

Prospective studies with a follow-up period of at least one year or observational studies with implants

placed in the aesthetic zone with a follow-up of at least one year (in function) were considered. The

aesthetic zone was defined from second premolar to second premolar. The adjacent teeth needed to be

natural. Case reports were considered, but excluded if <10 cases were evaluated. Treatments should have

been carried out with single titanium or ceramic endosseous implants. Single tooth implants should have

been placed immediately. Immediate implant placement was defined as implant placement immediately

following extraction of a tooth. At least one of the following factors needed to be reported: implant

survival, marginal peri-implant bone level change, change in peri-implant soft tissue, or aesthetic outcome

assessed by means of an objective index or patient questionnaire at last follow-up. There were no language

restrictions.

Quality assessment

Methodological quality was assessed by two reviewers (K.S. and L.H.) using specific study-design related

forms designed by the Dutch Cochrane Collaboration. The two observers independently assessed the

included articles8,10,11,15-49 based on the recommended approach for assessing risk of bias in Cochrane

reviews (Table 2).

Data extraction

The data that was extracted and re-organized is presented in Table 3.

Data regarding the following outcome variables (if present) were assessed:

- implant survival

- change in marginal peri-implant bone level (MBL) (the mean reported MBL was used, in studies with

mesial/distal MBL, the mean of the two was calculated and used for analysis)

- change in interproximal peri-implant mucosal level (IML; the mean reported IML was used, in studies

with mesial/distal IML, the mean of the two was calculated and used for analysis)

- change in midfacial peri-implant mucosal level (MML), Papilla index4, width of keratinized mucosa or

gingival index, bleeding index14, plaque index14, mean probing depth

- aesthetics assessed by means of an objective index6, 7

- patient satisfaction, assessed using an Oral Health Impact Profile (OHIP) index⁵, Visual Analogue

Scale (VAS) or questionnaire.

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Table 1. Search strategy.

MEDLINE

([MeSH terms / all subheadings] Dental Implants OR [MeSH terms / all subheadings] Dental Implantation OR

dental implant[tiab] OR dental implants[tiab] OR dental implantation[tiab] OR endosseous dental implantation[tiab] OR endosseous implantation[tiab] OR endosseous implant[tiab] OR single tooth[tiab] OR single teeth[tiab] OR single implant[tiab] OR single implants[tiab] OR single crown[tiab] OR single crowns[tiab] OR single restoration[tiab] OR single restorations[tiab])

AND

(aesthetic[tiab] OR esthetic[tiab] OR anterior[tiab] OR front[tiab] OR incisor[tiab] OR incisors[tiab] OR canine[tiab] OR canines[tiab] OR cuspid[tiab] OR cuspids[tiab] OR bicuspid[tiab] OR bicuspids[tiab] OR premolar[tiab] OR premolars[tiab])

AND (immediate[tiab] OR direct[tiab]

EMBASE

‘tooth implant’/exp OR ‘tooth implantation’/exp OR

‘dental implant’:ab,ti OR ‘dental implants’:ab,ti OR dental implantation:ab,ti OR ‘endosseous dental implantation’:ab,ti OR ‘endosseous implantation’:ab,ti OR ‘endosseous implant’:ab,ti OR ‘single tooth’:ab,ti OR ‘single teeth’:ab,ti OR ‘single implant’:ab,ti OR ‘single implants’:ab,ti OR ‘single crown’:ab,ti OR ‘single crowns’:ab,ti OR ‘single restoration’:ab,ti OR ‘single resto-rations’:ab,ti

AND

aesthetic:ab,ti OR esthetic:ab,ti OR anterior:ab,ti OR front:ab,ti OR incisor:ab,ti OR incisors:ab,ti OR canine:ab,ti OR canines:ab,ti OR cuspid:ab,ti OR cuspids:ab,ti OR bicuspid:ab,ti OR bicuspids:ab,ti OR premolar:ab,ti OR premolars:ab,ti

AND immediate:ab,ti OR direct:ab,ti

AND [embase]/lim

Cochrane

#1 search [MeSH terms / all subheadings] Dental Implants

#2 search [MeSH terms / all subheadings] Dental Implantation

#3 search ‘dental implant’ OR ‘dental implants’ OR dental implantation OR ‘endosseous dental implantation’ OR ‘endosseous implantation’ OR ‘endosseous implant’ OR ‘single tooth’ OR ‘single teeth’ OR ‘single implant’ OR ‘single implants’ OR ‘single crown’ OR ‘single crowns’ OR ‘single restoration’ OR ‘single restorations’

#4 aesthetic OR esthetic OR anterior OR front OR incisor OR incisors OR canine OR canines OR cuspid OR cuspids OR bicuspid OR bicuspids OR premolar OR premolars

#5 immediate OR direct

#6 search (#1 OR #2 OR #3) AND #4 AND #5

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20

Table 2. Summary of risk of bias of included studies

AuthorsAdequate sequence generation?

Allocation conceal-ment?

Blinding?

Incomplete outcome data addressed?

Free of selective reporting?

Free of other bias?

Risk of Bias

Lindeboom et al. 18 + + + + + + Low

Crespi et al.19 - - - + - ? High

Palattella et al.11 + + + + + + Low

De Rouck et al.22 + + + + + + Low

Block et al.20 ? + - + + - Medium

Raes et al.21 + - - + + + Low

Wöhrle23 NA NA NA ? - ? High

Groisman et al.24 NA NA NA ? - ? High

Norton25 NA NA NA ? ? ? High

Tsirlis26 NA NA NA ? ? ? High

Barone et al.27 NA NA NA - - ? High

Ferrara et al.28 NA NA NA - - ? High

Canullo et al.29 NA NA NA - - ? High

Covani et al. 30 NA NA NA + + ? Medium

Kan et al.31 NA NA NA + ? ? Medium

Cornelini et al.32 NA NA NA ? - ? High

Lops et al.33 NA NA NA + + ? Medium

Romeo et al.34 NA NA NA + ? ? High

Cordaro et al.36 NA NA NA + + ? Medium

Canullo et al. 37 NA NA NA + ? ? High

Crespi et al.38 NA NA NA + ? ? High

Cooper et al.39 NA NA NA + - ? High

Tortamano et al.40 NA NA NA + ? ? High

Valentini et al.41 NA NA NA + + ? Medium

Brown and Payne 42 NA NA NA + + ? Medium

Chung et al.43 NA NA NA + + ? Medium

Cosyn et al.8 NA NA NA + + ? Medium

Kan et al.44 NA NA NA + + ? Medium

Malchiodi et al.45 NA NA NA - + ? High

Pieri et al.46 NA NA NA + + ? Medium

Tsuda et al.47 NA NA NA + + ? Medium

Cabello et al.48 NA NA NA + + ? Medium

Cosyn et al.10 NA NA NA + + + Low

Grandi et al.49 NA NA NA + + ? Medium

Page 22: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

2

21

Statistical analysis

Pooled analysis

In order to perform a pooled data analysis and to identify potential predictive factors for the outcome

variables, all available study data were re-organized in a new data set. From the included manuscripts, all

available data were individualized after extraction. As such, raw data was obtained from these studies.

Fields that could not be individualized were left empty and censored in the analysis accordingly. All

analyses that could be performed were conducted on an individual patient level. The following predictors

were considered:

1. age, 2. sex, 3. timing of provisionalization (immediate or delayed,) 4. flap (yes or no), 5. connective

tissue graft (yes or no), 6. grafting material (autograft, allograft, xenograft with or without (non) resorbable

membrane), 7. biotype (thick or thin), 8. primary stability (divided in three groups: ≤25, 25-35, ≥35 N/cm), 9.

duration of temporary provisionalization (months), 10. material definitive restoration (ceramic or porcelain

fused to metal (PFM)), 11. screw- or cement-retained definitive crown.

Antibiotic use and the use of mouth rinse were not considered, as either all patients received antibiotics or

mouth rinse, or data were not reported.

95% confidence intervals (95%CI) of the survival proportion were calculated using the Wilson procedure

without continuity correction. It turned out that only data on implant survival and MBL could be

meaningfully combined into the pooled data analysis. Regarding the other variables, insufficient data was

available. Risk factors (Odds Ratio, OR) for implant survival (yes/no) were analyzed by multiple binary

logistic regression analysis. All factors with a p-value <0.10 were considered in the multiple model using a

backward elimination strategy. MBL was categorized into two groups: ≤0.50 mm and >0.50 mm bone loss.

For this outcome variable, also univariate binary logistic regression analysis was applied. Multivariable

regression analysis was not performed, as too few variables were available. Regarding IML and MML, too

few data was available to perform a regression analysis. A p-value <0.05 mm was considered to indicate

statistical significance. Missing data were censored in all analysis. All data analysis was performed with the

IBM SPSS, version 20.0.

Results

Study inclusion

The MEDLINE, EMBASE and Cochrane CENTRAL searches resulted in 993, 273 and 130 hits, respectively.

Figure 1 outlines the flow chart according to the PRISMA statement. After extracting duplicate citations,

637 publications remained to be screened. After screening of titles and abstracts, 98 publications were

selected for full-text analysis. Screening of bibliographies of relevant reviews and selected publications

revealed no additional publications. Of the 98 publications, 61 were excluded after full-text analysis and

quality assessment. Two disagreements occurred which were easily resolved in a consensus meeting. This

led to 38 studies available for initial analysis. Four studies15-17,35 were excluded from the pooled analysis

as the same patient population was described (only the study with the longest follow-up was used). In the

final pooled analysis, 34 studies were considered eligible for pooled analysis (Tables 2 and 3). Of these, 5

were RCTs11,18-20,22, 1 CT21 and 28 were observational studies8,10,23-34,36-49 .

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22

Tabl

e 3.

Cha

ract

eris

tics

of in

clud

ed s

tudi

es.

auth

ors

stud

y de

sign

setti

ng

follo

w-

up (m

)

patie

nts

follo

wed

impl

ants

(m

ax/m

an)

mea

n ag

e (y)

mal

eim

plan

t sys

tem

(ty

pe)

diam

eter

(m

m)

test

gr

oup

type

of

plac

e-m

ent

type

of

prov

ision

al-

izatio

n

fem

ale

leng

th

(mm

)co

ntro

l gr

oup

Lind

eboo

m e

t al.

18*

RCT

Inst

1250

50 (5

0/0)

39.9

( 16

.2)

25De

ntsp

ly

(Fria

lit-2

-Syn

chro

)3.

8-6.

525

IPDP

r39

.5 (1

2.9)

25NR

25DP

DPr

Cres

pi e

t al.

19*

RCT

Inst

2440

40 (4

0/0)

45.5

9 (2

4-62

)10

Swed

en &

Mar

tina

(Out

link)

3.75

-5.0

20IP

IPr

10

48.8

3 (2

7-68

)6

1320

IPDP

r14

Pala

ttel

la e

t al.

11*

RCT

Inst

2416

18 (1

8/0)

35 (2

1-49

)6

Stra

uman

n

(Tap

ered

Effe

ct)

4.1

9IP

IPr

1010

-12

9EP

IPr

De R

ouck

et a

l. 22

* RC

TIn

st12

4949

(49/

0)55

(13)

11No

bel B

ioca

re

(Nob

el re

plac

e)

4.3

or 5

.024

IPIP

r13

52 (1

2)12

10-1

625

IPDP

r13

Bloc

k et

al.

20*

RCT

Inst

2455

55 (5

5/0)

65.0

(49-

80)

14Bi

omet

3i (

Certa

in

Impl

ant)

NR26

IPIP

r15 10

11.5

-13

29DP

IPr

16

Raes

et a

l. 21

*CT

Inst

1248

48(4

8/0)

40 (1

9-75

)21

Astra

Tech

O

sseo

spee

d4.

0-5.

025

IP

IPr

2711

-17

23DP

IPr

Wöh

rle23

O

SPr

iv18

1414

(14/

0)NR

NRSt

eri-O

ss (R

epla

ce)

NRNA

IPIP

r

Groi

sman

et a

l. 24

O

SIn

st24

9292

(92/

0)NR

NRNo

bel B

ioca

re

(Rep

lace

)

3.5,

4.3,

5.

0,6.

0NA

IPIP

r13

,16

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2

23

Nort

on25

*O

SPr

iv20

.325

28 (2

8/0)

48.2

(27-

72)

10

Astra

Tech

(NR)

4.5

or 5

.0NA

IP

(n=1

6)IP

r15

11-1

7

Tsirl

is26

*O

SIn

st24

4343

(43/

0)20

-60

NR3i

(NT

Oss

eotit

e)3.

8-6.

5NA

IP

(n=2

8)IP

r13

Baro

ne e

t al. 2

7 O

SIn

st12

1818

(13/

5)22

-60

6Sw

eden

&M

artin

a (P

rem

ium

)>3

.75

NAIP

IPr

12>1

3

Ferr

ara

et a

l. 28

O

SIn

st30

3333

(33/

0)24

-58

16De

ntsp

ly (F

rialit

-2-)

3.8,

4.5,

5.5

NAIP

IPr

1713

or 1

5

Canu

llo e

t al.

29

OS

Priv

229

10 (1

0/0)

45.9

(33-

69)

2De

fcon

(TSA

TM

Serie

s 5

Defc

on)

6.0

NAIP

IPr

713

Cova

ni e

t al.

30

OS

Priv

1210

10(1

0/0)

42-5

55

Swed

en&

Mar

tina

(NR)

3.75

or 4

.0NA

IPDp

r5

13 o

r 15

Kan

et a

l. 31

O

SIn

st12

2323

(23/

0)39

.5 (2

5-63

)NR

Nobe

l Bio

care

(R

epla

ce S

elec

t)NR

NAIP

Ipr

Corn

elin

i et a

l. 32

OS

Priv

1234

34 (2

7/7)

43 (2

1-62

)19

Stra

uman

n (N

R)4.

8NA

IPIP

r15

10 o

r 12

Lops

et a

l. 33

O

SIn

st12

4646

(32/

14)

47.2

(18-

71)

25As

traTe

ch

(Oss

eosp

eed)

3.5,

4,4.

5NA

IPDP

r21

9,11

,13

Rom

eo e

t al.

34O

SIn

st12

4848

(20/

28)

46 (1

8-63

)22

Stra

uman

n

(sta

ndar

d pl

us T

E)3.

3,4.

1,4.8

NAIP

DPr

2610

or 1

2

Cord

aro

et a

l. 36

OS

Priv

18NR

30 (N

R)NR

NRSt

raum

an

(TE

impl

ants

)NR

NAIP

DPr

Canu

llo e

t al.

37

OS

Priv

3625

25 (2

5/0)

55 (1

3.5)

51

(7.7

) 14

Swed

en&

Mar

tina

(Glo

bal I

mpl

ants

)5.

5NA

IPIP

r9

13

Cres

pi e

t al.

38

OS

Inst

2430

30 (3

0/0)

51.2

(34-

71)

12Sw

eden

&M

artin

a (S

even

)3.

75 o

r 5.0

NAIP

DP

r18

13

Coop

er e

t al.

39*

OS

Inst

1213

915

7 (1

57/0

)45

.1 (1

4.2)

22As

traTe

ch

(Oss

eosp

eed)

3.5,

4.0,

4.

5,5.

0NA

IP

(n=5

5)IP

r33

11-1

9

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24

Tort

aman

o et

al.

40

OS

Inst

1812

12 (1

2/0)

22-5

43

Stra

uman

n4.

8NA

IPIP

r9

12

Vale

ntin

i et a

l. 41

*O

SIn

st12

4043

(43/

0)NR

NRAs

tra Te

ch (T

iO-

blas

t)4,

4.5,

5NA

IP

(n=2

0)

IPr

9,11

,13

Brow

n an

d Pa

yne

42

OS

Inst

1227

28 (2

8/0)

47.1

(21-

71)

9So

uth

Impl

ants

(C

o-Ax

is)

4 or

4.7

NAIP

IPr

1813

or 1

5

Chun

g et

al.

43

OS

Inst

1210

10 (8

/2)

52.1

(22.

7-67

.1)

6Bi

omet

3i (

Oss

eo-

tite

Prev

ail)

3.25,4

.0,5.

0NA

IPIP

r4

13 o

r 15

Cosy

n et

al.

8 O

SIn

st36

3030

(30/

0)54

(24-

76)

14No

bel B

ioca

re

(Rep

lace

TiU

nite

)4.

3 or

5.0

NAIP

IPr

1613

or 1

6

Kan

et a

l. 44

O

SIn

st48

3535

(35/

0)36

.5 (1

8-65

)8

Nobe

l Bio

care

(R

epla

ce)

3.75

NAIP

IPr

2713

,15,

18

Mal

chio

di e

t al.

45

OS

Inst

3658

64 (6

4/0)

39.9

(19-

78)

32NR

(Fas

t bon

e

rege

nera

tion

co

ated

impl

ants

)

3.25

-4.9

NAIP

IPr

2610

-16

Pier

i et a

l. 46

OS

Inst

1240

40 (4

0/0)

4614

Bios

park

(Sam

o Sm

iler I

mpl

ants

)NR

NAIP

IPr

2

Tsud

a et

al.

47

OS

Inst

1210

10 (1

0/0)

48 (3

5-70

)4

Astra

Tech

(O

sseo

spee

d)4.

0-5.

0NA

IPIP

r6

13-1

7

Cabe

llo e

t al.

48

OS

Priv

1214

14 (1

4/0)

52 (3

4-71

)7

Stra

uman

n (T

L RN.

NN

and

BL N

C and

RC)

NRNA

IPIP

r7

Cosy

n et

al.

10

OS

Priv

1222

22 (2

2/0)

50 (2

7-74

)12

Nobe

l Bio

care

(N

obeA

activ

)NR

NAIP

IPr

10

Gran

di e

t al.

49

OS

Inst

1236

36 (3

6/0)

37.4

(35-

60)

16JD

enta

l Car

e (JD

E-vo

lutio

n)3.

7,4.

3,5

NAIP

IPr

208-

15

* on

ly im

med

iate

impl

ants

acc

ount

ed in

poo

led

anal

ysis

Stud

y des

ign:

RCT

rand

omize

d co

ntro

lled

trial

, CT

Cont

rolle

d tri

al, O

S =

obse

rvat

iona

l stu

dy; S

ettin

g: In

st=

Inst

itutio

n, P

riv=

Priv

ate

prac

tice;

Follo

w up

: m=m

onth

s;

Impl

ants

: max

=max

illa,

man

=man

dibu

la; M

ean

age:

y=ye

ar; N

R= N

ot R

epor

ted;

mm

=mill

imet

er; T

est g

roup

/con

trol g

roup

: NA=

Not

App

licab

le; T

ype

of p

lace

men

: IP

= Im

med

iate

Pla

cem

ent,

DP=D

elay

ed P

lace

men

t, EP

=Ear

ly P

lace

men

t; Ty

pe o

f pro

visi

onal

izatio

n: IP

r= Im

med

iate

Pro

visi

onal

izatio

n, D

Pr=

Dela

yed

Prov

isio

naliz

atio

n.

Page 26: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

2

25

Tabl

e 3.

(con

tinue

d)

auth

ors

reas

on e

xtra

ctio

n

antib

iotic

s

mou

th-

rinse

flap

con-

nect

ive

tissu

e gr

aft

graf

ting

mat

eria

l (T

G/CG

)

biot

ype

prim

ary

stab

ility

(N

/cm

)

dura

tion

tem

pora

ry

prov

isio

n-al

izat

ion

(m

onth

s)

defin

itive

pr

ovis

ion-

aliz

atio

n-m

ater

ial

(PFM

/Cer

)

reta

ined

de

finiti

ve

prov

isio

n-

aliz

atio

n (c

em/s

crew

)

Lind

eboo

m e

t al.

18pe

ri-ap

ical

pat

holo

gyye

s 60

0 m

gye

s

6dye

sNR

Aut

+Bio

GNR

≥25

6NR

cem

Cres

pi e

t al.

19tra

uma,

end

odon

tic

failu

re ,

carie

s,

perio

dont

al fa

ilure

yes

1g

prio

r and

2x

for 1

w

yes

2x

d

15d

yes

in

CG

NRNR

NR≥2

53

PFM

cem

Pala

ttel

la e

t al.

11

root

frac

ture

n=2

en

dodo

ntic

failu

re n

=6

carie

s n=

5 pe

riodo

ntal

failu

re n

=1

agen

esis

n=4

yes

1 g 2

x fo

r 5d

yes

1wye

sNR

NRNR

35NR

PFM

n=1

6

Cer n

=2ce

m/s

crew

De R

ouck

et a

l. 22

toot

h fra

ctur

e n=

14

endo

dont

ic fa

ilure

/ca

ries

n=16

ro

ot re

sorp

tion

n=4

pe

riodo

ntal

failu

re n

=15

yes

500

mg

prio

r and

3x

for 5

d

yes

2xd

2w

yes

NR

BioO

thic

k≥3

56

PFM

cem

BioO

+B

ioG

Bloc

k et

al.

20NR

yes

7dNR

yes

in

CG

NRye

s,

othe

rNR

NR4

PFM

cem

Raes

et a

l. 21

fract

ure

n=13

ca

ries/

endo

dont

ic

failu

re n

=17

root

reso

rptio

n n=

6

perio

dont

al fa

ilure

n=4

ag

enes

is n

=8

yes

500

mg

1h

preo

p an

d 3x

for 5

d

yes

2x 1w

IN n

=9IN

Noth

ick/

thin

NR2

Cer

cem

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26

Wöh

rle23

NRNR

NRye

s NR

NRNR

456

NRNR

Groi

sman

et a

l. 24

NRye

s 7d

yes

15

dNR

NRAu

tNR

NR6

Cer

NR

Nort

on25

heal

ed s

ite a

nd

traum

a

root

fract

ure

en

dodo

ntic

failu

re

perio

dont

al fa

ilure

ag

enes

is

yes

3g p

rior

and

250

mg

3x

for 5

d

yes

1wIN

NRNR

NR

254.

5PF

M a

nd

Cer

NR

Tsirl

is26

heal

ed s

ite n

=15

othe

r rea

sons

NR

NRNR

yes

NRot

her+

Bi

oG n

=10

NRNR

6NR

NR

Baro

ne e

t al.

27

NRye

s

1h p

reop

2g

and

1.5g

mg

post

op

yes

2xd

3wno

NRno

NRNR

6PF

MCe

m

Ferr

ara

et a

l. 28

root

frac

ture

yes

1g 2

xd fo

r 1w

yes

1wNR

NRAu

tNR

NR

6PF

MNR

Canu

llo e

t al.

29NR

yes

1g

yes

2wno

NRBi

oO

if ga

p >1

mm

thick

n=

6/

thin

n=3

32-4

54

Cer

NR

Cova

ni e

t al.

30

NRye

s 50

0 m

g 4x

for 4

d ye

sno

yes

NRNR

NR6

NRNR

Kan

et a

l. 31

NRye

sye

sye

s IN

n=

15ye

s IN

n=

11Au

t or

BioO

thic

k n=

10/

thin

n=1

3NR

6PF

MCe

m

Corn

elin

i et a

l. 32

root

frac

ture

, end

-od

ontic

failu

re, c

arie

s,

perio

dont

al fa

ilure

yes

fo

r 8d

yes

2xd

for

2wye

sye

s n=

17Bi

oG IN

NRNR

6NR

NR

Lops

et a

l. 33

endo

dont

ic, c

arie

s le

sion

s, ro

ot o

r cro

wn

fract

ures

NRNR

yes

NRNR

thic

kNR

5PF

MCe

m

Page 28: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

2

27

Rom

eo e

t al.

34

endo

dont

ic, c

arie

s le

sion

s, ro

ot o

r cro

wn

fract

ures

NRNR

yes

NRNR

thick

n=

35

thin

n=1

4 n=

9 ex

cl

NR5

PFM

Cem

Cord

aro

et a

l. 36

NR

NRNR

yes

NRNR

thic

k n=

16/

thin

n=1

3NR

NRNR

NR

Canu

llo e

t al.

37

root

frac

ture

n=8

en

dodo

ntic

failu

re/

carie

s n=

17

yes

2g

+ 1g

1h p

rior

chx

0.12

%

2wno

NRot

her I

N

thic

k n=

6/

thin

n=4

th

ick

n=7/

th

in n

=8

32-4

53

PFM

Cem

Cres

pi e

t al.

38

peri-

apic

al p

atho

logy

n=

15

root

frac

ture

s/ c

arie

s n=

15

yes

1g 2

xd fo

r 1w

yes

2x fo

r 15

dye

sNR

NRNR

>25

6PF

MCe

m

Coop

er e

t al.

39

NRIN

yes

yes

in

n=15

NRNR

NR<5

03

Cer

Cem

Tort

aman

o et

al.

40

root

h fra

ctur

e n=

7 en

dodo

ntic

failu

re n

=2

root

reso

rptio

n n=

2

caire

s= n

=1

NRNR

nono

noNR

yes

1.5

PFM

Scre

w

Vale

ntin

i et a

l. 41

Trau

ma,

frac

ture

, en

dodo

ntic

failu

re,

carie

s

Infe

cted

site

n=1

8 ye

s 1g

/14

dye

sye

sNR

BioO

n=

17

NR≥4

03

NRCe

mNo

Infe

ctio

n n=

25

yes1

g/7d

BioO

+ Bi

oG n

=26

Brow

n an

d Pa

yne42

endo

dont

ic fa

ilure

n=3

ca

ries

n=5

toot

h fra

ctur

e n=

19

agen

esis

n=1

yes

only

pre

-op

yes

noNR

NRNR

20-4

52

Cer

Scre

w

Page 29: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

28

Chun

g et

al.

43NR

yes

post

- op

yes

2wNR

NRBi

oONR

≥30

6PF

Mce

m/s

crew

Cosy

n et

al.

8

fract

ure

n=10

ca

ries/

endo

dont

ic

failu

re n

=9

root

reso

rptio

n n=

4

perio

dont

al fa

ilure

n=7

yes

1h p

reop

500

mg

and

3x fo

r 5d

yes

2wye

sNR

BioO

norm

al/

thic

k>3

56

PFM

Cem

Kan

et a

l. 44

to

oth

fract

ure

n=15

en

dodo

ntic

failu

re n

=12

root

reso

rptio

n n=

8

yes

500

mg

4xd

yes

noNR

BioO

an

d/or

Bi

oG

n=3

thic

k n=

14/

thin

=21

NR6

PFM

Cem

Mal

chio

di e

t al.

45

traum

a, to

oth/

root

fra

ctur

es, c

arie

s, e

nd-

odon

tic fa

ilure

, roo

t re

sorp

tion,

per

iodo

n-ta

l fai

lure

s,

yes

3g1h

prio

r and

8h

afte

r

yes

prio

r an

d 2x

d af

ter

nono

Aut

thic

k/th

inye

s6

PFM

and

Ce

rCe

m

Pier

i et a

l. 46

ro

ot fr

actu

re, e

nd-

odon

tic fa

ilure

, car

ies,

pe

riodo

ntal

failu

re

yes

2g 1

h pr

ior a

nd

2xd

for1

w

yes

1wno

NRAu

t+

BioO

NR40

4PF

M a

nd

Cer

NR

Tsud

a et

al.

47

NRye

sye

s 2w

yes

yes

BioO

NR25

-35

6Ce

rCe

m

Cabe

llo e

t al.

48fra

ctur

e/no

ferru

le n

=3

carie

s/en

dodo

ntic

n=1

0 in

tern

al re

sopt

ion

n=1

yes

500-

750

mg/

8h/7

d

yes

2x 10

d no

nono

URNR

4PF

M a

nd

Cer

scre

w/c

em

Cosy

n et

al.

10fra

ctur

e n=

11

carie

s n=

9

root

reso

rptio

n n=

2

yes

1,00

mg

2x fo

r 4d

yes

noIN

BioO

NR≥3

56

Cer

cem

/scr

ew

Gran

di e

t al.

49

toot

h fra

ctur

e n=

9 ca

ries

n=14

en

dodo

ntic

failu

re n

=9

perio

dont

al fa

ilure

n=4

yes

1g 1h

prio

r an

d 2x

for 6

d

yes

2x 3

d pr

ior

+ 2x

2w

nono

BioO

NR70

.55

(35-

80)

4PF

Mce

m/s

crew

UR =

Und

er re

porte

d, IN

= If

nec

essa

ry, T

G =

Test

Gro

up, C

G= C

ontro

l Gro

up, A

ntib

iotic

s: D

= d

ays,

W =

wee

k, M

g =

mill

igra

m, G

= g

ram

, Pre

-op

= pr

e op

erat

ive,

Gra

ft-in

g m

ater

ial:

Aut =

Aut

ogen

ou, B

ioG

= Bi

o Gu

ide,

Gei

stlic

h Bi

omat

eria

ls, B

ioO

= B

io O

ss, G

eist

lich

Biom

ater

ials

, Prim

ary

stab

ility

: N/c

m =

New

ton/

cent

imet

ers,

Defin

i-tiv

e pr

ovis

iona

lizat

ion

mat

eria

l: PF

M =

Por

sela

in Fu

sed

Met

al, C

er =

Cer

amic

, Ret

aine

d de

finiti

ve p

rovi

sion

aliz

atio

n: ce

m =

cem

ente

d, s

crew

= s

crew

ed.

Page 30: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

2

29

UR =

Und

er re

porte

d, IN

= If

nec

essa

ry, T

G =

Test

Gro

up, C

G= C

ontro

l Gro

up, A

ntib

iotic

s: D

= d

ays,

W =

wee

k, M

g =

mill

igra

m, G

= g

ram

, Pre

-op

= pr

e op

erat

ive,

Gra

ft-in

g m

ater

ial:

Aut =

Aut

ogen

ou, B

ioG

= Bi

o Gu

ide,

Gei

stlic

h Bi

omat

eria

ls, B

ioO

= B

io O

ss, G

eist

lich

Biom

ater

ials

, Prim

ary

stab

ility

: N/c

m =

New

ton/

cent

imet

ers,

Defin

i-tiv

e pr

ovis

iona

lizat

ion

mat

eria

l: PF

M =

Por

sela

in Fu

sed

Met

al, C

er =

Cer

amic

, Ret

aine

d de

finiti

ve p

rovi

sion

aliz

atio

n: ce

m =

cem

ente

d, s

crew

= s

crew

ed.

Tabl

e 3.

(con

tinue

d)

auth

ors

impl

ant

surv

ival

m

argi

nal b

one

loss

ch

ange

in in

ter-

prox

imal

muc

osal

le

vel (

mm

)

chan

ge in

m

idfa

cial

m

ucos

al

leve

l

(mm

)

papi

lla in

dex

0/1/

2/3/

4 M

/D

ging

iva

inde

x

0/1/

2/3

or

KM (m

m)

blee

ding

in

dex

0/1/

2/3

or

scor

e (%

)_

plaq

ue

inde

x

0/1/

2/3

or

scor

e (%

)

prob

ing

dept

h

(mm

)

aest

hetic

s

patie

nt

satis

fac-

tion

(%

)M

ean

(sd)

M/D

(s

d)M

ean

(sd)

M/D

(s

d)

Lind

eboo

m

et a

l. 18

920.

51

M 0

.49

(0.1

1)/

D 0.

53

(0.1

2)NR

NR

0/0/

5/18

/0

NRNR

NRNR

NRNR

100

0.52

M 0

.52

(0.1

6)/

D 0.

52

(0.1

4)

0/0/

7/18

/0

Cres

pi e

t al

. 19

100

1.02

(0

.53)

M 0

.93

(051

)/

D 1.

10

(0.2

7)NR

NRNR

NR7

7NR

NRNR

100

1.16

(0

.51)

M 1.

16

(0.3

2)/

D 1.

17

(0.4

1)

Pala

ttel

la

et a

l. 11

100

0.54

(0

.51)

NR

NR

-0.8

(0

.7)

0/3/

8/7/

0

NRNR

NRNR

NRNR

100

0.46

(1

.01)

NR-0

.6

(0.6

)0/

2/7/

9/0

Page 31: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

30

De R

ouck

et

al.

22

960.

86

M 0

.92

(0.4

9)/

D 0.

79

(0.5

4)

0.38

M 0

.44

(0.7

7)/

D 0.

31

(0.8

1)

0.41

(0

.75)

NRNR

40(1

3)16

(15)

3.6

(0.6

1)

NR

VAS

93 (8

2-10

0)

920.

97

M 0

.96

(0.2

5)/

D 0.

97

(0.3

5)

0.48

M 0

.43

(0.4

2)/

D 0.

53

(0.5

5)

1.16

(0

.66)

36(1

3)

17(1

8)3.

27 (0

.53)

VA

S 91

(80-

96)

Bloc

k et

al

. 20

872.

45

M 2

.81

(1.1

3)/

D

2.08

(0

.81)

NR

0.75

NRNR

NRNR

NRNR

NR

972.

57

M 2

.79

(0.9

8)/

D 2.

34

(0.5

7)

0.75

Raes

et

al. 21

940.

85

(0.6

4)NR

0.16

+0.0

7 (0

.99)

/ 0.

38

(1.2

1)D

0.12

(0

.78)

NRNR

83/1

7/0/

085

/11/

4/0

NR

PES/

WES

10

.33

(2.2

9)/

7.2

(2.0

4)

OHI

P 69

.67

(0.6

2)

100

0.65

(0

.79)

NR0.

45

+0.3

(1

.38)

M/

+0.6

(0

.87)

D

1.00

(1

.15)

PES/

WES

10

.35

(1.5

8)

/7.0

0 (2

.37)

OHI

P 67

.39

(6.2

1)

100

0.56

(0

.44)

NR0.

38

+0.6

1 (0

.87)

M/

0.14

(0

.47)

D

0.49

(0

.82)

PES/

WES

10

.11

(1.9

0)

/7.2

2 (1

.86)

OHI

P 68

.00

(4.5

8)

Page 32: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

2

31

Wöh

rle23

10

0NR

UR

Not m

ore

>1.0

NRUR

>1

.0 in

n=

2NR

NRNR

NRNR

NRNR

Groi

sman

et

al.

2494

NR

n=85

No

t mor

e >2

.0

n=1

4.0

UR

n=3

>2

.0NR

0/2/

2/82

/0NR

NRNR

NRNR

NR

Nort

on25

96

.40.

24

(nr)

NRNR

NRNR

NRNR

NRNR

NRNR

Tsirl

is26

100

0.75

(1

.05)

NRNR

NRNR

NRNR

NR0.

3 (0

.2)

NRNR

Baro

ne e

t al

. 27

951.

4

(0.3

)NR

NRNR

NR3.

3 (0

.5)

6167

1.6

(0.8

)NR

NR

Ferr

ara

et

al. 28

97

URNR

NRNR

NRNR

NRNR

NRNR

SAQ

Canu

llo e

t al

. 2910

00.

78

(0.3

6)M

0.5

7/

D 1.

01+0

.25

+0.2

NRNR

NRNR

2.8

NRNR

Cova

ni e

t al

. 3010

01.

5

(0.5

)NR

NRNR

NR4.

1 (0.

5)NR

NR3.

0 (0

.8)

NRNR

Kan

et

al. 31

100

UR (n

ot

>1.0

0)NR

NRUR

(n=8

<1

.5)

NRNR

NRNR

NRNR

NR

Corn

elin

i et

al.

3210

00.

7

(nr)

NRUR

(0.2

-0.8

5)NR

0/0/

41/2

7/0

NRNR

NRNR

NRNR

Lops

et

al. 33

10

0DM

NRNR

NRUR

45/1

/0/0

NRNR

NRNR

NR

Rom

eo e

t al

. 3410

0DM

NRNR

NRUR

NRNR

NRNR

NRNR

Page 33: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

32

Cord

aro

et

al. 36

97

0.54

(0

.33)

n=15

NRNR

<1 n

=12

>1<2

n=

13

>/ n

=4

NR

3.47

(0

.99)

20

UR

2.57

(0

.87)

n=

15NR

NR0.

63

(0.5

3)n=

14

2.57

(0

.93)

212.

88

(1.0

1)

n=14

Canu

llo e

t al

. 3710

0

0.34

(0

.07)

n=15

NRNR

NRNR

0.98

(0

.11)

1.67

(0

.3)

0.61

(0

.08)

2.80

(0

.21)

NRNR

0.55

(0

.09)

n=10

Cres

pi e

t al

. 38

100

0.86

(0

.54)

n=15

NR0.

20

(0.1

3)NR

0.25

(0

.18)

NR3.

67

(0.6

1)0.

77

(0.3

3)0.

74

(0.2

9)2.

05

(0.6

6)NR

NR0.

82

(0.5

2)n=

15

Coop

er e

t al

. 3994

.51.

18

(1.1

9)NR

UR-0

.35

(0.8

9)NR

DR *

NRNR

NRNR

NR

Tort

aman

o et

al.

4010

0DM

URNR

NRNR

NRNR

NRNR

NRNR

Vale

ntin

i et

al.

41

100

n=10

1,20

n=

10

M 1,

03

(0,9

5)/

D 1,

41

(1,0

2)

n=10

NRNR

2.81

(0.5

)NR

NRNR

NRNR

NR

100

n=10

0,93

n=

10

M 0

,87

(1,1

3)/

D 0,

99

(0,9

9)n=

10

Page 34: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

2

33

Brow

n an

d Pa

yne

4292

.9+0

.2

(0.6

)NR

NR0.

2 (0

.99)

M 0

/2/1

8/7/

0 D

0/2/

/12/

13NR

NRNR

NRNR

NR

Chun

g et

al

. 4390

0.31

(0

.34)

NRNR

0.05

(3

.67-

0.94

/ 3.

72/

1.03

)

M 0

/0/1

/8/0

D

0/1/

1/6/

0NR

NRNR

NRNR

NR

Cosy

n et

al

. 896

1.00

(1

.13

M/

0.86

D)NR

NRNR

NRNR

NRNR

PES/

WES

10

.48

(2.4

7)/

8.17

(1

.52)

NR

Kan

et

al. 44

100

0.68

M 0

.72

(0.2

7)/

D 0.

63

(0.2

1)

0.22

M 0

.22

(0.3

4)/

D

0.21

(0

.41)

1.13

(0

.87)

NRNR

NRNR

NRNR

NR

Mal

chio

di

et a

l. 45

100

0.8

(0.6

)NR

0.7

M 0

.6

(0.5

)/

D 0.

8 (0

.6)

0.5

(0

.6)

DRNR

NRNR

NRNR

NR

Pier

i et

al. 46

94.7

n=

20

0.20

(0

.17)

n=20

NR

0.26

n=

20

M 0

.24

(0.2

1)/

D 0.

28

(0.1

9)n=

20

0.61

(0

.54)

n=20

3.86

(0.7

2)n=

20

NRNR

NRNR

NRNR

100

n=20

0.51

(0

.24)

n=20

0.33

n=

20

M 0

.33

(0.1

9)/

D 0.

33

(0.2

3)n=

20

0.73

(0

.52)

n=20

3.84

(0.5

7)n=

20

Tsud

a et

al

. 4790

-0.1

4 (0

.33)

NR

NR2.

25

(1.2

1)NR

NRNR

NRNR

NRNR

Page 35: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

34

Cabe

llo e

t al

. 4810

0NR

NR0.

58

M 0

.36

(0.6

)/

D 0.

8 (0

.96)

0.45

(0

.25)

NRUR

NRNR

NRNR

NR

Cosy

n et

al

. 1095

.20.

1 (0.

5)NR

0.35

M 0

.2

(0.5

)/

D 0.

5 (0

.5)

0.2

(0.4

)NR

NRNR

NRNR

NR

PES/

WES

12

.15

(0.9

9)/

8.63

(1

.07)

Gran

di e

t al

. 4997

.20.

51NR

NRNR

NRNR

NRNR

NRNR

NR

DM =

Diff

eren

t Mea

sure

men

ts, I

N =

If Ne

sces

sary

, sd

= st

anda

rd d

evia

tion,

M =

mes

ial,

D =

dist

al, m

m =

mill

imet

er, S

AQ =

Sel

f Adm

inis

tere

d Q

uest

ionn

aire

Page 36: University of Groningen Immediate dental implant placement ... · of immediate dental implant placement in the aesthetic zone. The treatment outcome consisted out of changes in hard

2

35

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Figure 1. Flow chart of study selection procedure according to the PRISMA statement.

MEDLINE = 993 EMBASE = 273

COCHRANE = 130 1,396 records identified

through database searching

No additional records identified through other

sources

637 records after duplicates removed

338 records screened

98 full-text articles assessed for eligibility

38 studies included in quantitative synthesis

34 studies included in quantitative synthesis (pooled analysis)

4 studies excluded because the same

patients were studied

4 studies excluded because the same

patients were studied

240 records excluded

Identification

Screening

Eligibility

Included

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Statistical analysis

Pooled analysis

In order to perform a pooled data analysis and to identify potential predictive factors for the outcome

variables, all available study data were re-organized in a new data set. From the included manuscripts, all

available data were individualized after extraction. As such, raw data was obtained from these studies.

Fields that could not be individualized were left empty and censored in the analysis accordingly. All

analyses that could be performed were conducted on an individual patient level. The following predictors

were considered:

1. age, 2. sex, 3. timing of provisionalization (immediate or delayed,) 4. flap (yes or no), 5. connective

tissue graft (yes or no), 6. grafting material (autograft, allograft, xenograft with or without (non) resorbable

membrane), 7. biotype (thick or thin), 8. primary stability (divided in three groups: ≤25, 25-35, ≥35 N/cm), 9.

duration of temporary provisionalization (months), 10. material definitive restoration (ceramic or porcelain

fused to metal (PFM)), 11. screw- or cement-retained definitive crown.

Antibiotic use and the use of mouth rinse were not considered, as either all patients received antibiotics or

mouth rinse, or data were not reported.

95% confidence intervals (95%CI) of the survival proportion were calculated using the Wilson procedure

without continuity correction. It turned out that only data on implant survival and MBL could be

meaningfully combined into the pooled data analysis. Regarding the other variables, insufficient data was

available. Risk factors (Odds Ratio, OR) for implant survival (yes/no) were analyzed by multiple binary

logistic regression analysis. All factors with a p-value <0.10 were considered in the multiple model using a

backward elimination strategy. MBL was categorized into two groups: ≤0.50 mm and >0.50 mm bone loss.

For this outcome variable, also univariate binary logistic regression analysis was applied. Multivariable

regression analysis was not performed, as too few variables were available. Regarding IML and MML, too

few data was available to perform a regression analysis. A p-value <0.05 mm was considered to indicate

statistical significance. Missing data were censored in all analysis. All data analysis was performed with the

IBM SPSS, version 20.0.

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Table 4. Characteristics of included studies.

N (median) % (range)

Total number of implants assessed 985 100

Survival of implants 956 97

Age of patients (46) (35-65)

Sex • Male • Female • NR

985 361 364 260

100 36.6 37.0 26.4

Mean follow up (months) (18) (12-48)

Provisionalization • Immediate • Delayed

985 752 233

100 76.3 23.7

Antibiotic use • Yes • No • NR

985 752 0 233

100 76.3 0 23.7

Mouth rinse use • Yes • No • NR

985 875 0 110

100 88.8 0 11.2

Flap • Yes • No • NR

985 355 384 246

100 36.0 39.0 25.0

Connective tissue graft • Yes • No • NR

985 40 90 855

100 4.1 9.1 86.8

Grafting material • Autogenous • BioOss • BioOss + Bioguide • Autogenous+ BioOss • Autogenous+ BioGuide • Other • No • NR

985 192 158 34 64 25 86 89 337

100 19.5 16.0 3.5 6.5 2.5 8.7 9.0 34.2

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Biotype • Thick • Thin • NR

985 222 30 732

100 22.5 3.0 74.3

Primary Stability (Ncm) • ≤25 • 25<>35 • ≥35 • NR

985 111 64 306 481

100 11.3 6.5 31.1 48.8

Mean duration of temporary provi-sionalization (months) (6) (2-6)

Definitive crown material • Ceramic • PFM • NR

985 220 490 275

100 22.3 49.7 27.9

Type of definitive crown • Cement-retained • Screw-retained • NR

985 602 41 342

100 61.1 4.2 34.7

NR = not reported

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Table 5. Risk factors for implant survival and marginal bone level change >0.50 mm.

implant survival marginal bone level change >0.50 mm

OR CI (95%) P OR CI (95%) P

Provisionalization (reference: immediate) 1.50 0.57-3.99 0.41 58.03 8.05-418.41 0.00

Flap 0.83 0.33-2.06 0.69 19.87 10.21-38.66 0.00

Connective tissue graft 0.89 0.08-10.07 0.92 4.56 1.72-12.08 0.002

Material (reference: autogenous) • BioOss • BioOss + Bioguide • Autogenous+ BioOss • Autogenous+ BioGuide • Other • No

1.33 0.70 2.74 0.50 1.20 1.89

0.43-4.15 0.14-3.43 0.34-22.33 0.1-2.50 0.31-4.65 0.39-9.09

0.78 0.62 0.66 0.35 0.40 0.79 0.3

0.25 NA 0.00 NA 0.24 NA

0.12-0.50 NA NA NA 0.51 NA

0.012 0.00 NA NA NA NA NA

Biotype (reference: thick) 1.20 0.14-10.00 0.87 4.23 0.26-70.16 0.32

Primary stability (ref ≤25 N/cm) • 25<>35 • ≥35

0.57 0.49

0.08-4.14 0.11-2.26

0.66 0.58 0.36

0.01 0.17

0.01-0.04 0.08-0.34

0.00 0.00 0.00

Material Definitive crown (reference: ceramic) 2.12 0.95-4.72 0.07 1.29 0.81-2.05 0.28

Way of connecting Definitive Provisionalization (reference: cement-retained)

0.50 0.11-2.26 0.37 0.01 0.00-0.03 0.00

OR = Odds Ratio CI = Confidence Interval

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Results

Study inclusion

The MEDLINE, EMBASE and Cochrane CENTRAL searches resulted in 993, 273 and 130 hits, respectively.

Figure 1 outlines the flow chart according to the PRISMA statement. After extracting duplicate citations,

637 publications remained to be screened. After screening of titles and abstracts, 98 publications were

selected for full-text analysis. Screening of bibliographies of relevant reviews and selected publications

revealed no additional publications. Of the 98 publications, 61 were excluded after full-text analysis and

quality assessment. Two disagreements occurred which were easily resolved in a consensus meeting. This

led to 38 studies available for initial analysis. Four studies15-17,35 were excluded from the pooled analysis

as the same patient population was described (only the study with the longest follow-up was used). In the

final pooled analysis, 34 studies were considered eligible for pooled analysis (Tables 2 and 3). Of these, 5

were RCTs11,18-20,22, 1 CT21 and 28 were observational studies8,10,23-34,36-49 .

Patient characteristics

In the pooled analysis of 34 studies, 985 implants in 979 patients were analyzed. Characteristics are shown

in Table 4. Median age in the studies considered was 46 years (range 35-65 years). Median follow-up was

18 months (range 12-48 months). Most patients underwent immediate provisionalization (76.9%).

Risk factors for implant survival

Out of 985 implants, 956 survived (97.1%, 95%CI 0.958-0.980) (Table 4). After multiple analysis (Table 5),

no variables were significantly associated with survival.

Risk factors for changes in marginal peri-implant bone level (MBL)

A mean marginal bone loss of 0.81±0.48 mm was identified after at least 12 months follow-up. Univariate

regression analysis (Table 5) showed that delayed provisionalization was significantly associated with

bone loss >0.50 mm (OR 60.2, 95%CI 8.36-434.04, p<0.001). Also, the use of a flap (OR 20.3, 95%CI 10.52-

39.65, p<0.001) and connective tissue graft (OR 4.56, 95%CI 1.72-12.08, p< 0.001) were both significantly

associated with marginal bone loss >0.50 mm. In addition, primary stability of >25 N/cm (25-35 N/cm: OR

0.01, 95%CI 0.01-0.04, p<0.001, >35N/cm: (OR 0.16, 95%CI 0.08-0.34, p<0.001) and the use of a screw-

retained instead of a cement-retained provisional crown (OR 0.01,95%CI 0.00-0.04, p<0.001) were both

strongly associated with marginal peri-implant bone loss <0.50 mm.

Mean changes in peri- implant soft tissue

Mean loss of interproximal (IML) and midfacial mucosa level (MML) was 0.38±0.23 mm and 0.54±0.39 mm

after at least 12 months follow-up, respectively.

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Discussion

Survival of immediately placed implants was excellent with 97% after at least one year follow-up and

comparable with previously published survival rates.12 Timing of provisionalization was not associated with

outcome in terms of implant survival. These are important results, underlining the advantage of immediate

provisionalization as survival rates of implants were not inferior to those of delayed provisionalization.

Regarding risk factors for MBL, immediate provisionalization was associated with bone level change of

<0.50 mm, which is, to our opinion, a clinically relevant observation. From this, it may be concluded that

micromotion is possibly not as important as previously thought in terms of MBL loss. Furthermore, the

use of a flap and connective tissue graft was also significantly associated with a MBL change of >0.50

mm, thereby confirming a recent observation that the use of a flap should be avoided when possible.27

When an implant site does not need a complementary connective tissue graft during the installation of

the dental implant, favorable conditions are probably already present. It is hypothesized that immediate

provisionalization, as was performed in the majority of cases included in this review, without a flap or

connective tissue graft, is associated with less MBL. In future studies, not only MBL should be taken

into account, but also buccal bone level (BBL) change. The presence or absence of buccal bone may

influence final outcome. The pre-operative surgical site is not always suitable for immediate placement

and provisionalization as well as that there are clinical conditions in which immediate placement is not

an optimal treatment option, e.g. in (severely) inflamed areas or in medically compromised patients. In

such cases, the surgical site is usually optimized by the use of a flap or connective tissue graft or special

precautions have to be taken. However, the reasons for extraction of the tooth to be replaced were mostly

underreported. Obviously, the pre-operative condition of the peri-implant tissues is of critical importance

for the definitive result of the implant. The mean calculated MBL is in line with other studies17,21,22, as well as

the calculated interproximal mucosa level (IML) and midfacial mucosa level (MML)16,17.

It was not possible to analyze the role of antibiotics and mouth rinse in this study as antibiotics were used

in all included studies or its use was not reported. In addition, the included studies used different types

and schedules of antibiotics. Whether or not to use antibiotics in single implant placement obviously is

an important topic of discussion as the use of antibiotics in a healthy population has never proven its

benefits.50 Further research regarding the need for antibiotics when placing implants in healthy subjects is

warranted.

Some limitations of the present study have to be addressed. It was not possible to analyze all data on an

individual patient base, as a lot of data were not available in the studies considered eligible for this review.

Regarding MBL, a cut-off value of 0.50 mm was taken. One could discuss whether this is appropriate. It

was not possible to use it as a continuous variable as differences were too small to perform a reliable

regression analysis. Also, as individual patient data were not available, a cut-off value on basis of the

results could not be calculated. In the literature, no studies have been performed in this way, so this item

is open for discussion. To our opinion, a cut-off value of 0.50 mm makes sense as only this difference in

height is possible to measure in clinical practice and can be seen on plain dental radiographs. As multiple

analysis could not be performed, we cannot exclude that some variables significant after univariate

analysis, are not associated with MBL if correction had been possible. Also, as measurements of mucosal

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level changes were not standardized, the reported data in the included studies have to be interpreted

carefully, as it is not always clear how measurements took place.

Another important issue is the patient population studied. Individual patient factors such as presence of

diabetes or other co-morbidities are very relevant in clinical practice, but medically compromised patients

had been excluded in all included studies to obtain “clean results”. The same holds true for smoking

(only non-smoking patients were included in the various studies). For clinical practice, these factors are

important when it comes to implant survival rates and dimensions of the hard and soft tissues in the

aesthetic zone. The results of the present study which is based on a systematic review of the available

literature should, therefore, be interpreted with caution. Nevertheless, the present results may have

some important implications for clinical practice. An important current issue is the gaining interest in

patient satisfaction. In view of this, immediate placement and provisionalization in the aesthetic zone

has some important advantages: the patient immediately benefits from this treatment method which can

substantially have a positive impact on the patient’s quality of life. Thus, aesthetic indexes and patient

satisfaction scales have to be applied, in addition to the already used treatment outcome parameters,

in future studies assessing the treatment outcome of immediate placement of dental implants in the

aesthetic zone.

Conclusion

Immediate placement with immediate provisionalization of dental implants in the aesthetic zone results in

an excellent short-term treatment outcome in terms of implant survival and minimal change of peri-implant

soft and hard tissue dimensions.

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3Feasibility of immediate placement

of single-tooth implants in

the aesthetic zone:

a 1-year randomized controlled trial.

This chapter is an edited version of the manuscript:Slagter KW, Meij er HJ, Bakker NA, Vissink A, Raghoebar GM.

Feasibility of immediate placement of single-tooth implants in the aesthetic zone: a 1-year randomized controlled trial. J Clin Periodontol 2015; 42: 773–782.

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Abstract

Aim:

to assess whether outcome of immediate implant placement and immediate

provisionalization after one year was non-inferior to immediate implant placement and

delayed provisionalization regarding Marginal Bone Level (MBL).

Materials and Methods:

Forty patients with a failing tooth in the aesthetic zone were randomly assigned

for immediate implant placement with immediate (n=20) or delayed (n=20)

provisionalization. Follow-up was at 1 month and after one year. The study was powered

to detect a difference in MBL of <0.9 mm. Apart from MBL, soft tissue peri-implant

parameters, aesthetic indexes and patient satisfaction were assessed. (www.isrtcn.com:

ISRCTN57251089)

Results:

After one year, MBL changes were 0.75±0.69 mm mesially and 0.68±0.65 mm distally

for the immediate group and 0.70±0.64 and 0.68±0.64 mm for the delayed group,

respectively. Regarding differences in means, non-inferiority was observed after 1 year

(mesially: Immediate vs. Delayed: difference in mean 0.08 mm (95%CI -0.38 to 0.53,

p=0,71), distally: Immediate vs. Delayed: difference in mean 0.09 mm (95%CI-0.37 to 0.56

mm, p=0.66)). No significant differences in the other outcome variables were observed.

Conclusion:

This study showed that immediate placement and immediate provisionalization was non-

inferior to immediate placement with delayed provisionalization. In addition, although not

powered for these outcome variables, no clinically relevant differences in other outcomes

were observed.

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Introduction

Traditionally, placement and restoration of dental implants is a process involving a long period1, therefore

the quest for a shorter treatment period is imminent. Currently, there is a growing tendency to place single

tooth implants in the aesthetic zone immediately after extraction of a failing tooth, preferably combined

with immediate provisionalization.2,3 This tendency is probably related to evolving society factors, with

more demanding patients and a wish for direct treatment. Innovations in implant surfaces and designs

have facilitated the possibilities for such an approach.4 In view of these developments, immediate

placement and provisionalization of implants is nowadays presumed to be a reliable treatment option for

single tooth implants in the aesthetic zone.5,6

In line with this presumption, in a systematic review and pooled analysis7, it was demonstrated that

immediate placement with immediate provisionalization of dental implants in the aesthetic zone resulted

in an excellent short-term treatment outcome in terms of implant survival. Besides implant survival,

establishment and maintenance of healthy hard and soft peri-implant tissues are crucial too, particularly in

the aesthetic zone.8,9 Therefore, the interest in hard and soft tissue dynamics related to immediate single

tooth implant placement in the aesthetic zone increased.10,11

To objectively rate implant-based aesthetics, a number of aesthetic indexes has been developed including

the Implant Crown Aesthetic Index (ICAI)12; the pink aesthetic score (PES)13, and the white aesthetic score

(WES)14,15. To rate the opinion of the patients themselves patient-centered outcomes as the Visual Analogue

Scale (VAS)16 and Oral Health Impact Profile (OHIP)17 have been developed.

Inherent to the shift in interest to patient-centered outcomes, few studies have yet been conducted in

which outcome measures are systematically assessed.18,19 Currently, to the best of our knowledge, no

randomized clinical trials assessing the full panel of outcome measures, including changes in the hard

and soft tissue dimensions, implant survival, aesthetic evaluation and patient-centered outcome in the

aesthetic zone, have been published. Therefore, the aim of this randomized controlled trial was to assess

whether outcome of immediate implant placement and immediate provisionalization after one year was

non-inferior to immediate implant placement and delayed provisionalization regarding MBL. Our null

hypothesis stated that the difference in means of MBL between the two treatment groups would be greater

or equal to 0.9 mm. Soft peri-implant tissues, aesthetics and patient-centered outcomes in the aesthetic

zone were also assessed.

Materials and methods

Study design

All consecutive patients (age ≥ 18 year) with a failing tooth in the maxillary aesthetic zone (incisor, canine

or first premolar) referred to the department of Oral and Maxillofacial Surgery between January 2010 and

January 2012 for single tooth implant treatment, were considered if adequate oral hygiene and sufficient

space were present and when eligible asked to participate in this randomized clinical trial (Figure 1 and

2). The size of the bone defect was assessed after extraction of the failing tooth. The shape of the osseous

defect was checked by a bone sounding technique with a periodontal probe at the midfacial, the mesial,

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and distal aspect of the failing tooth, and the mesial and distal aspect of the immediately adjacent teeth.

The patient was only included in the present study if the buccal socket wall had a bony defect of <5 mm in a

vertical direction. For allocation to a group determined by the bony defect, a computerized random number

generator was used. A research-nurse not involved in the study blindly allocated the patients to:

- Group A : immediate placed implant (NobelActive, Nobel Biocare AB, Goteborg, Sweden) and

immediate provisionalization;

- Group B: immediate placed implant (NobelActive, Nobel Biocare AB, Goteborg, Sweden) and delayed

provisionalization.

Informed consent was obtained from all patients. The study was approved by the local medical ethical

committee (NL32240.042.10) and registered in a trial register (www.isrtcn.com: ISRCTN57251089).

Surgical protocol

Preoperatively, patients started prophylactic antibiotic therapy (amoxicillin 500mg t.i.d. for 7 days

or clindamycin 300mg q.i.d. in case of amoxicillin allergy). Oral disinfection composed of a 0.2%

chlorhexidine mouthwash, twice daily for 7 days.

All surgeries were performed under local anesthesia. First, the attached periodontal ligament from the

failing tooth was carefully detached by an incision in the sulcus. Periotomes were used to extract the failing

tooth atraumatically. No mucoperiosteal flap was raised. The implant site was prepared on the palatal side

of the alveolus following the protocol of the manufacturer using a surgical template based on the ideal

position of the prospective implant crown. The last used burr, depending on the diameter of the implant,

was placed in the prepared alveolus. The remaining space between the burr and the peri-implant bone was

locally augmented. As grafting material, autogenous bone from the retromolar–ramus area was gathered

using a bonescraper (Bonescraper, Biomet 3i, Warsaw, Indiana, USA) 1:1 mixed with anorganic bone

(Geistlich Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland). Regarding the corono-apical position of

the implants, the shoulder of the implant was placed at a depth of 3 mm apical to the most apical aspect of

the prospective clinical crown, with help of a surgical template.

Group A : immediate placed implant and immediate provisionalization

An implant-level impression was made immediately after implant placement. After the impression, a

corresponding healing abutment was placed. In the dental laboratory, a screw-retained provisional crown

was fabricated by means of an engaging temporary abutment and composite. The provisional restoration

was free from centric and eccentric contacts with the antagonist teeth. Approximately 6 hours following

implant placement, the healing abutment was removed, and the provisional crown was screwed directly

onto the implant with 20 Ncm by a manual torque wrench (Manual Torque Wrench Prosthetic; Nobel Biocare

AB).

Group B: immediate placed implant and delayed provisionalization.

immediately after implant placement a corresponding cover screw was placed. Following a standard

protocol20 for an optimal aesthetic outcome, a free oval full thickness soft-tissue graft was punched and

harvested from the palatal mucosa. The diameter of the punch was 2 mm larger than the socket access.

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Figure 1. Cohort flow diagram.

Enrollment Assessed for eligibility (n=40)

Excluded (n=0) • Not meeting inclusion criteria (n=0) • Declined to participate (n=0) • Other reasons (n=0)

Allocated to intervention (n=20) • Received allocated intervention (n=20) • Did not receive allocated interven tion (give reasons) (n=0)

Lost to follow-up (give reasons) (n=1, patient did not show up at appointments) Discontinued intervention (give reasons) (n=0)

Analysed (n=19) • Excluded form analysis (give reasons) (n=0)

Allocated to intervention (n=20) • Received allocated intervention (n=20) • Did not receive allocated interven tion (give reasons) (n=0)

Lost to follow-up (give reasons) (n=0) Discontinued intervention (give reasons) (n=0)

Analysed (n=20) • Excluded form analysis (give reasons) (n=0)

Randomized (n=40)

Allocation

Follow-Up

Analysis

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That 2 mm of epithelium was removed from soft tissue graft. The 2 mm zone of the soft tissue graft denuded

from epithelium was located beneath the mucosa at the recipient site. This was done to facilitate closure

and healing of the grafted area. The graft was sutured with Ethilon 5-0 (Johnson & Johnson, Amersfoort, The

Netherlands) on top of the reconstructed socket. During the three months osseointegration phase, patients

were allowed to wear a removable partial denture not interfering with the wound. After three months,

the implant was uncovered by a small incision at the site of the cover screw, followed by an implant-level

impression according to the procedure described in group A. All surgical procedures were performed by one

experienced oral and maxillofacial surgeon (GR).

Prosthetic protocol

A final open tray impression using polyether impression material (Impregum Penta, 3M ESPE, Seefeld,

Germany) was taken at implant level after a provisional phase of 3 months in both groups. In the dental

laboratory, a digital design of the definitive crown was made to the desired form of the abutment. The digital

design was used to retrieve individualized zirconia abutments (NobelProcera, Nobel Biocare AB). Depending

on the location of the screw access hole, the final crown was either a cemented-retained or screw-retained

zirconia crown (Procera, NobelBiocare AB). Abutment screws were torqued with 32 Ncm. Cement-retained

crowns were cemented with glass ionomer cement (Fuji Plus, GC Europe, Leuven, Belgium). All prosthetic

procedures were performed by one experienced prosthodontist (HM).

Outcome measures

Primary outcome measure of this study was the change in marginal peri-implant bone level (MBL) proximal

to the implant, 12 months after placement of the definitive crown on the mesial and the distal site.

Secondary outcome measures included implant survival, change in interproximal peri-implant mucosa

(IML) and change in midfacial peri-implant mucosal level (MML) as compared with the gingival level of

the pre-operative failing tooth. Furthermore, papilla volume, biotype prior to removal of the tooth, health

of keratinized gingiva, amount of plaque, amount of bleeding and pocket probing depth were assessed.

Aesthetic outcome was assessed by means of objective indexes (ICAI, PES/WES). Patients’ satisfaction was

assessed using the Oral Health Impact Profile (OHIP) index and the Visual Analogue Scale (VAS) on a 0-10

scale.

Radiographic assessments

To calculate changes in MBL, a standardized digital peri-apical radiograph was taken with an individualized

aiming device21, pre-operatively (Tpre), immediately following implant placement (baseline, T0), one month

(T1), and twelve months (T12) after definitive crown placement. The vertical distance from the shoulder

of the implant to the first-bone-to-implant contact was measured at the distal and mesial site of the

implant. The radiographs of T1 and T12 were analyzed using the known implant diameter as a reference.

The manufacturer provided the exact dimension of the implants used. Measurements were independently

performed by two examiners (KS and Harry Slagter), after which the average of both measurements was

used.

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Survival rate

Survival rate was defined as the percentage functional implants one year after definitive crown placement

in both groups. The criteria for successful osseointegration according to Smith & Zarb (1989) were adapted.

Photographic assessments

Before implant placement (Tpre) and after placement of the definitive crown standardized digital

photographs (Nikon D300s, Nikon Corporation,Yurakucho, Tokyo, Japan) were taken at T1 and T12 using

a technique as described earlier.21 A manual periodontal probe (Williams Color-Coded probe; Hu-Friedy,

Chicago, IL, USA) was held in close proximity and parallel to the long axis of the adjacent tooth. The known

dimensions of the periodontal probe allowed for calibration of the photographs. Full screen analysis of the

photographs was performed using a digital picture editing program (Keynote, Apple Inc, Cupertino, CA,

USA). The changes in IML and in MML were compared with the original gingival level of the failing tooth.

These measurements were independently performed by two examiners (KS and Harry Slagter) after which

the average of both measurements was used.

Clinical assessments

The following clinical variables were assessed at T1 and T12 both at the implant and adjacent teeth before

implant placement (Tpre) and after finalization of the definitive crown:

- Papilla volume: assessing the mesial and distal papilla adjacent to the implant using the papilla

index22;

- Amount of plaque: assessed at four sites per implant/adjacent tooth (mesial, buccal, distal and

palatinal) using the modified plaque index23;

- Amount of bleeding: using the modified sulcus bleeding index23;

- Gingiva: using the gingival Index24;

- Probing pocket depth: assessed at four sites per implant/adjacent tooth (mesial, buccal, distal and

palatinal) using a manual periodontal probe (Williams Color-Coded probe; Hu-Friedy, Chicago, IL, USA)

measuring to the nearest 1 mm.

All data were retrieved by one blinded examiner (KS).

Aesthetic assessments

The aesthetic outcome was assessed on standardized digital photographs (Nikon D300s, Nikon

Corporation) taken at Tpre and T1, and T12 in both groups. An additional photograph was taken of implant

crowns replacing the lateral or canine capturing the contra lateral tooth. Peri-implant mucosa and implant

crown aesthetic outcomes were determined using ICAI12 and PES-WES14. Measurements were independently

performed by two examiners (KS and Diederik Hentenaar).

Patients’ satisfaction

Patients’ satisfaction was assessed at T1 and T12 using the validated OHIP-14 questionnaire.17 Overall

satisfaction compared to Tpre was questioned using a 100-mm VAS scale.16

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Figure 2A. Schedule of visits and procedures study group A: immediate placement and

immediate provisionalization.

Inclusion

Prosthetic phase

Healing phase

Follow-up phase

Pre-operative TPre

Screening and Measurements

Extraction &

Implant placement

& Immediate

provisionalization

Definitive crown and Follow-up

Follow-up

Day 0 (T0)

3 months (T3)

12 months (T12)

15 months (T15)

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Figure 2B. Schedule of visits and procedures study group A: immediate placement and

delayed provisionalization.

Inclusion

Prosthetic phase

Healing phase

Follow-up phase

Pre-operative TPre

Screening and Measurements

Extraction &

Implant placement

& Delayed

provisionalization

Second phase surgery

& Provisional crown

Definitive crown and Follow-up

Follow-up

Day 0 (T0)

3 months (T3)

6 months (T6)

12 months (T12)

18 months (T18)

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Statistical analysis

For determination of the sample size, G*power version 3.1 was used.25 A radiographic MBL of <0.9 mm (SD

1 mm) after 12 months of definitive crown placement was regarded as a relevant difference between study

groups5. With an expected effect-size of 0.9 mm, an alpha of 0.05 and a power of 0.80, 38 patients were

required, 19 in each group. 40 patients were included to deal with possible redrawal.

Shapiro-Wilk test, together with normality plots were used to assess normal distribution of the continuous

variables. Differences between groups were evaluated by one-way analyses of variance (ANOVA) for

continuous data and by Fisher’s exact test or chi-Square test for categorical data. Regarding MBL, T-tests

for equality of means with associated confidence intervals (CI) were calculated. If the difference of 0.9

did not pass the 95% CI borders, non-inferiority was considered established. In case of uncertainty of

the significance because of the relatively small number of patients analysed and the large number of

outcomes, Bonferroni correction was considered in case of a p-value 0.01<>0.05. Inter- and intra-examiner

measurements were repeated twice by two independent observers in a random order. A p-value of 0.05 was

considered to indicate statistical significance. All analyses were performed using SPSS (PASW Statistics

20.0, SPSS Inc.; IBM Corporation, Chicago, IL, USA).

Results

Inter- and intra-observer correlation

Measurements were repeated twice by two independent observers in a random order. For the radiographic

assessment, the interobserver intraclass correlation coefficient was 0.88 (95CI 0.83-0.92). The intraobserver

intraclass correlation coefficient was 0.89 (95CI 0.83- 0.97) for observer one and 0.83 (95CI 0.80-0.95) for

observer two. For the photographic assessment, the interobserver intraclass correlation coefficient was

0.93 (95CI 0.88-0.98). The intra-observer intraclass correlation coefficient was 0.93 (95CI 0.87- 0.96) for

observer one and 0.90 (95CI 0.88-0.96) for observer two. For ICAI and PES-WES, the interobserver intraclass

correlation coefficient were 0.88 (95CI 0.77-0.94) and 0.87 (95CI 0.75 -0.94), respectively. The reliability from

all different assessments proved to be acceptable.

Patients

Baseline and clinical characteristics of groups A (n=20) and B (n=20) as well as details on surgical and

prosthetic procedures are depicted in Table 1 and Figures 3 and 4. One patient in group B was lost to follow

up immediately after definitive crown placement. All patients received their assigned treatment.

Change in marginal bone level

Table 2 shows the mean MBL changes at the mesial and distal site after twelve months in relation to the time

point of connecting the definitive crown. Regarding differences in means, non inferiority was observed (at a

level of 0.9 mm), both after 3 months (mesially: Group A vs. B: difference in mean 0.02 mm (95%CI -0.42 to

0.46 mm, p=0.64, distally: Group A vs. B: difference in mean 0.06 mm (95%CI -0.40 to 0.52 mm, p=0.66) as

well as after 1 year (mesially: Group A vs. B: difference in mean 0.08 mm (95%CI -0.38 to 0.53 mm, p=0.71,

distally: Group A vs. B: difference in mean 0.09 mm (95%CI -0.37 to 0.56 mm, p=0.66).To analyze the uneven

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Table 1. Baseline characteristics and treatment specifications per study group.

Variable Group A (n=20)

Group B (n=20)

Mean age ±sd (range) 39.4±16.9 (19-70) 42.3±14.2 (23-66)

Male/female 5/15 8/12

Implant site location I1/I2/C 7/8/5 13/6/1

Cause of tooth loss • Fracture (crown or root) • Agenesis • Caries • Endodontic failure • Periodontal failure • Root resorption

7 6 0 2 0 5

10 0 1 6 0 3

Bone defect mean±sd (mm) 3.40±1.19 4.21±1.08

Length implant (mm) 13/15/18 2/16/2 2/9/9

Diameter (mm) 4.3/ 3.5 12/8 15/5

Type of final restoration • Screw-retained • Cement -retained

14 6

12 8

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distribution of the agenesis patients (6 vs. 0, see Table 1) additional analyses were performed, comparing

both groups with the agenesis patients excluded, as well as an a analysis in group A comparing the

differences between the agenesis patients and other patients, showing no significant differences between

both groups (data not shown).

Survival rate

No implants were lost during the study resulting in an implant survival rate of 100% at one year after

placement of the definitive crown for both groups.

Change in interproximal and midfacial peri-implant mucosal level

Table 2 shows the soft tissue level changes from the pre-operative situation up to 12 months after

placement of the definitive crown at the mesial, distal and mid-facial site. Again, the largest IML change

was observed early after placement of the definitive crown, with an observed statistical significant,

persisting difference with regard to the mesial papilla in both groups (0.89±0.46 mm (immediate) and

0.32±0.43 mm (delayed), p<0.001). Between the 1 and 12 months evaluation, only minor, non-significant

changes were observed with regard to IML and MML.

Clinical outcome

The health of the keratinized gingiva remained stable, and the plaque and bleeding indexes remained low

throughout the study period (Table 3). Even at one year of follow-up no plaque was seen in both groups.

Pocket probing depth remained stable for both groups on all four measured sites: mesial, distal, buccal

and palatal.

Aesthetic assessments

The ICAI and PES/WES scores are shown in Table 2. After one year, an acceptable clinical ICAI and PES/

WES outcome was seen in 94% patients of both groups A and B. The total aesthetic outcome was mainly

influenced by the appearance of the implant crown (WES) and to a lesser extent by the peri-implant mucosa

(PES). A positively significant difference in aesthetic outcome was measured over time within each group.

No significant difference was measured between both groups.

Patients’ satisfaction

At the first follow-up visit after definitive crown placement, no significant differences between both

groups were observed. After one year, however, VAS scores were 8.2±0.9 and 9.1±0.8 for groups A and B,

respectively (p<0.002). Regarding the OHIP-14 (Table 4), no statistical significances were observed between

both groups one year after definitive crown placement.

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Table 2. Changes regarding marginal bone level, marginal soft tissue level and aesthetic evaluation from pre-operative (Tpre), one month (T1) to 12 months (T12) after definitive crown placement.

Tpre Tpre P-value T1 T1 P-value T12 T12 P-value

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Variable

Group A

Group B

Group A

Group B

Group A

Group B

Marginal bone level in mm(±sd)

Mesial of implant 0.70 (±0.67)

0.68 (±0.64) 0.92 0.75

(±0.69)0.68 (±0.65) 0.73

Distal of implant 0.69 (±0.71)

0.64 (±0.63) 0.80 0.70

(±0.64)0.68 (±0.64) 0.68

Marginal soft tissue level changes in mm (±sd)

Mesial of implant 0.90 (±0.45)

0.44 (±0.45) 0.003 0.89

(±0.46)0.32 (±0.43) 0.001

Distal of implant 0.44 (±0.45)

0.78 (±0.67) 0.54 1.00

(±0.58)0.79 (±0.66) 0.33

Mid-facial of implant 1.15 (±0.81)

0.78 (±0.86) 0.18 0.95

(±0.62)0.85 (±0.86) 0.71

PES 7.00 (2.05)

6.90 (1.32) 0.63 7.80

(1.66)7.40 (1.59) 0.71 7.50

(1.59)7.40 (1.46) 0.79

WES 5.00 (2.33)

5.40 (1.65) 0.70 7.99

(1.73)7.60 (1.09) 0.68 8.10

(0.90)7.90 (1.08) 0.79

PES/WES 11.60 (3.33)

11.10 (3.46) 0.43 16.20

(2.20)15.10 (1.71) 0.38 15.80

(2.05)15.30 (2.11) 0.50

ICAI 9.6 (06.54)

14.10 (8.57) 0.23 3.80

(2.18)6.20 (3.94) 0.35 4.20

(2.38)5.2 (4.10) 0.37

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Figure 3. Immediate implant treatment with immediate provisionalization.

a Clinical situation pre-operative.

b. Pre-operative radiograph.

c. Clinical situation post-operative after one year.

d. Post-operative radiograph after one year.

3b

3a

3c

3b

3d

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Figure 4. Immediate implant treatment with delayed provisionalization.

a Clinical situation pre-operative.

b. Pre-operative radiograph.

c. Clinical situation post-operative after one year.

d. Post-operative radiograph after one year.

3b

4a

4c

4b

4d

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Table 3. Clinical outcome measures from pre-operative to 12 months after definitive crown placement.

Tpre Tpre P-value T1 T1 P-value T12 T12 P-value

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Variable

Group A

Group B

Group A

Group B

Group A

Group B

Papilla volume (papilla index 0/1/2/3/4)

Mesial 1.95 (1.10)

1.95 (0.85) 0.99 2.16

(0.83)2.37 (0.60) 0.38 2.35

(0.81)2.67 (0.77) 0.23

Distal 2.05 (0.99)

1.68 (0.67) 0.19 2.37

(0.76)2.00 (0.67) 0.12 2.45

(0.76)2.28 (0.75) 0.49

Health of gingiva (gingival index (0/1/2/3)

0.00 (0.00)

0.00 (0.00) NA 0.90

(0.31)0.79 (0.42) 0.35 0.80

(0.70)0.94 (0.24) 0.41

Amount of plaque (plaque index)

0.10 (0.31)

0.05 (0.23) 0.59 0.00

(0.00)0.05 (0.23) 0.31 0.00

(0.00)0.00 (0.00) NA

Bleeding after probing (bleeding index)

0.75 (0.55)

0.68 (0.58) 0.71 0.60

(0.60)0.47 (0.61) 0.52 0.25

(0.44)0.22 (0.43) 0.85

Pocket probing depth (mm)

Mesial 2.70 (0.80)

2.44 (0.71) 0.31 3.50

(0.83)3.21 (0.71) 0.25 2.95

(0.76)3.11 (0.32) 0.41

Distal 2.85 (1.09)

2.61 (0.70) 0.43 3.15

(0.49)3.21 (0.92) 0.80 3.05

(0.61) 3.50 (0.71) 0.41

Buccal 1.60 (0.75)

1.89 (0.96) 0.31 2.65

(1.42)2.79 (0.86) 0.72 3.05

(0.83)3.00 (0.59) 0.83

Palatal 1.65 (0.81)

2.06 (0.80) 0.13 2.30

(0.66)2.79 (0.42) 0.18 2.90

(0.55)2.89 (0.32) 0.94

NA = not applicable

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Table 4. OHIP scores from one month to one year of functioning.

Mean OHIP-14 Group A Group B

T0 –T1 P-value

Group A Group B

T1-T12 P-value

Variable

never/hardly ever/occasionally/fairly often/very often

never/hardly ever/occasionally/fairly often/very often

Question 1 Have you had trouble pronouncing any words because of problems with your teeth, mouth or dentures?

0/18/0/2/0 0/17/0/2/0 0.96 0/20/0/0/0

0/17/2/0/0 0.20

Question 2 Have you felt that your sense of taste has worsened because of problems with your teeth, mouth or dentures?

0/20/0/0/0 0/16/3/0/0 0.06 0/16/1/3/0

0/16/2/0/0 0.29

Question 3 Have you had a painful aching in your mouth?

0/15/2/3/0 0/14/2/3/0 0.90 0/20/0/0/0

0/17/2/0/0 0.60

Question 4 Have you found it uncomfortable to eat any foods because of problems with your teeth, mouth or dentures?

0/14/2/4/0 0/11/6/2/0 0.99 0/15/4/1/0

0/15/3/1/1 0.43

Question 5 Have you been self-conscious of your teeth, mouth or dentures?

0/14/3/2/1 0/15/2/2/0 0.22 0/13/4/3/0

0/16/2/1/0 0.65

Question 6 Have you felt tense because of problems with your teeth, mouth or dentures?

0/18/2/0/0 0/15/2/2/0 0.75 0/17/2/1/0

0/14/3/1/1 0.45

Question 7 Has your diet been unsatisfactory because of problems with your teeth, mouth or dentures?

0/19/1/0/0 0/18/0/1/0 0.33 0/14/4/1/0

0/15/4/0/0 0.29

Question 8 Have you had to interrupt meals because of problems with your teeth, mouth or dentures?

0/14/4/1/1 0/17/1/1/0 0.37 0/15/4/1/0

0/16/3/0/0 0.94

Question 9 Have you found it difficult to relax because of problems with your teeth, mouth or dentures?

0/14/1/5/0 0/17/1/1/0 0.38 0/13/4/3/0

0/15/2/2/0 0.54

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Question 10 Have you been a bit embarrassed because of problems with your teeth, mouth or dentures?

0/14/1/5/0 0/13/3/3/0 0.47 0/17/2/1/0

0/13/3/1/1 0.54

Question 11 Have you been a bit irritable with other people because of problems with your teeth, mouth or dentures?

0/16/2/2/0 0/17/2/0/0 0.37 0/14/4/1/0

0/15/2/2/0 0.39

Question 12 Have you had difficulty doing your usual jobs because of problems with your teeth, mouth or dentures?

0/18/2/0/0 0/17/2/0/0 0.23 0/15/4/1/0

0/15/3/1/0 0.61

Question 13 Have you felt that life in general was less satisfying because of problems with your teeth, mouth or dentures?

0/18/2/0/0 0/17/2/0/0 0.21 0/13/4/3/0

0/15/3/1/0 0.38

Question 14 Have you been totally unable to function because of problems with your teeth, mouth or dentures?

0/19/0/1/0 0/17/2/0/0 0.21 0/18/2/0/0

0/17/2/0/0 0.29

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Discussion

The present study showed that immediate placement and immediate provisionalization was not inferior to

immediate placement with delayed provisionalization with the difference in means of MBL between the two

treatment groups being smaller <0.90 mm, thereby rejecting the null-hypothesis. Only some statistically

significant differences were observed in VAS-score and mesial IML after one year. These differences were

not regarded clinically relevant.

Peri-implant hard and soft tissue dimensions

The results of the present study are in line with other clinical studies26-28 on immediate placement in

the aesthetic zone with regard to change in MBL. In a recent systematic review, a mean MBL change of

0.81±0.48 mm was reported.⁷ These results were based on 43 studies reporting on immediate placement

of single tooth implants in the aesthetic zone. This study is in line with these findings with a reported MBL

change after one year of 0.75±0.69 mm mesially and 0.68±0.65 mm distally for the immediate group and

0.70±0.64 mm and 0.68±0.64 mm for the delayed group). In this systematic review, a change of IML of

0.38±0.23 mm and a mean change of MML of 0.54±0.39 mm was reported, the mean change of IML and

MML reported in this study was within this range.⁷

It has been described that immediate implant placement is associated with an increased risk for recession

of the peri-implant tissues.9,29 In this study, in our opinion, recession of peri-implant tissues was still

clinically acceptable after one year (IML of 1.00±0.58 mm and MML 0.95±0.62 mm). The observed

significant difference between groups A and B with regard to the mesial IML, probably can be explained

by the absence of immediate support by a provisional crown in group B as well as the use of a removable

denture. Theoretically, after placement of a provisional crown, peri-implant tissues have the possibility to

gain height due to support of the provisional crown.

Clinical outcome

We reported a 100% survival rate of immediately placed implants in the aesthetic zone, comparable with

known numbers.5,7,30 With regard to the papilla volume, we showed that papilla volume gained after one

year. This phenomenon has also been demonstrated in studies involving conventional22,31 and immediate

implant placement.26,28 In this study, pocket probing depths and the health of the keratinized gingiva

remained stable throughout the study period, while the plaque and bleeding indexes remained low in both

groups.

Aesthetic assessments

PES/WES scores did not differ statistically between both groups and were comparable to the aesthetic

results published in the literature regarding single tooth implants in the aesthetic zone.14,32-34 This is an

important observation, as the present study specifically assessed differences in the aesthetic zone.

Obviously further improvement of the aesthetic results is always desirable.

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Patients’ satisfaction

Over the last years, there is an increasing focus on patient-reported outcome measures within the field

of implant dentistry.35 Immediate placement and provisionalization are known to be associated with high

subjective satisfaction rates.36 This is in line with the patients’ satisfaction perceived by the patients in

this study. Regarding the OHIP-14, no significant differences were observed between these groups during

the entire follow-up, again in line with other studies.32,37 The significant difference after one year in the VAS

score, though, is not considered to be a clinically relevant difference as more than a 13 point difference on

the 100-point VAS is needed to obtain a clinically relevant difference.38 In addition, the observed difference

might be explained by the fact that patients in group A were satisfied immediately, as provisionalization

was performed the same day, while the other patients had to deal with a removable denture for three

months making them even more satisfied with the final results as they had experienced the misery of

wearing a removable denture for three months.

Limitations of the study

Some limitations have to be addressed. First, and most important, regarding the non-inferiority design we

have to admit that the chosen maximal difference in means of <0.9 mm is debatable. In retrospect, a (much)

smaller difference in means would have been better to prove non-inferiority. For now, we can only conclude

that immediate provisionalization is not inferior to delayed provisionalization when considering a margin

<0.9 mm as equal. However, because the data shows that the difference in MBL between both groups in

fact is much smaller, it is reasonable to assume that with a smaller difference in means (and thus a larger

sample size), immediate provisionalization would also be non-inferior to delayed provisionalization. On

basis of these results (comparable results for both treatment designs), it also can be presumed that any

difference observed between both treatments when increasing the sample size will be clinically rather

irrelevant. Regarding the other outcome parameters we can only conclude that it seems that there is

not a large difference between both groups. However, as this study was not powered do detect relevant

differences for these outcome measures, no firm conclusions can be drawn from these observations.

The second limitation is directly linked to the imbalance between both groups after randomization. All

agenesis patients (n=6) were allocated to group A after randomization. Taking a closer look at these

patients, no significant differences were present between agenesia patients and patients with a failing

tooth for other reasons allocated to group A. It is therefore unlikely that this imbalance between both

groups influenced our results.

In this study a maximum bony defect of 5 mm was used. However, it is difficult to measure the bony defect

when the tooth is still in situ. The reasons of tooth loss can be very diverse, so randomization took only

place on the bony defect. Given the seemingly favourable outcomes of immediate placement in this study,

immediate placement in a larger bony defect should certainly be considered in future studies.

Conclusion

The present study showed that immediate placement and immediate provisionalization was non-inferior

compared with immediate placement with delayed provisionalization regarding MBL at a level <0.9 mm. The

outcome is hampered by the large margin for differences in means taken for non-inferiority. In this respect,

further research in larger groups of patients is warranted to monitor the outcome measures, also on the

long-term.

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NP. The microbiota associated with successful

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26. Lindeboom JA, Frenken JW, Dubois L, Frank M,

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27. Crespi R, Cappare P, Gherlone E, Romanos

GE. Immediate versus delayed loading of

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28. Palattella P, Torsello F, Cordaro L. Two-year

prospective clinical comparison of immediate

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30. Esposito M, Grusovin MG, Polyzos IP, Felice P,

Worthington HV. Interventions for replacing

missing teeth: dental implants in fresh

extraction sockets (immediate, immediate-

delayed and delayed implants). Cochrane

Database Syst Rev 2010;(9)(9):CD005968.

31. Henriksson K, Jemt T. Measurements of soft

tissue volume in association with single-

implant restorations: a 1-year comparative

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32. Raes F, Cosyn J, De Bruyn H. Clinical, Aesthetic,

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Loaded Single Implants in the Anterior Maxilla:

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Healed Ridges, and Grafted Sites. Clin Implant

Dent Relat Res 2012;

33. den Hartog L, Raghoebar GM, Slater JJ,

Stellingsma K, Vissink A, Meijer HJ. Single-

tooth implants with different neck designs:

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34. Santing HJ, Raghoebar GM, Vissink A, den

Hartog L, Meijer HJ. Performance of the

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consecutive patients. Clin Oral Implants Res

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35. McGrath C, Lam O, Lang N. An evidence-based

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subjects. J Clin Periodontol 2012;39 Suppl

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37. Raes F, Cooper LF, Tarrida LG, Vandromme H, De

Bruyn H. A case-control study assessing oral-

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4Immediate single-tooth implant

placement in bony defects in the

aesthetic zone:

a 1-year randomized controlled trial.

This chapter is an edited version of the manuscript:Slagter KW, Meij er HJ, Bakker NA, Vissink A, Raghoebar GM.

Immediate single-tooth implant placement in bony defects in the esthetic zone: a 1-year randomized controlled trial. Journal of Periodontology.

Epub ahead of publication. 2016;15:1-15.

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Abstract

Aim:

To assess whether outcome of immediate implant placement in the aesthetic zone in bony

defects was non-inferior to delayed implant placement after one year regarding marginal

bone level (MBL).

Materials and Methods:

Forty patients with a failing tooth in the aesthetic zone and a labial bony defect of ≥5 mm

after removal of a tooth were randomly assigned for immediate (n=20) or delayed (n=20)

implant placement. Second stage surgery and provisionalization occurred after three

months healing. Follow-up was at 1 month and 1 year after definitive crown placement.

The study was powered to detect a difference in MBL of >0.9 mm. Buccal bone thickness,

soft tissue peri-implant parameters, aesthetic indexes and patients’ satisfaction were also

assessed.

Results:

One year after definitive crown placement, MBL level loss was 0.49±0.46 mm mesially

and 0.49±0.46 mm distally for the immediate group and 0.45±0.41 mm and 0.68±0.64

mm for the delayed group, respectively. Regarding differences in means, non-inferiority

was observed after 1 year (mesially: immediate vs. delayed: difference in mean 0.04 mm

(95%CI -0.22 to 0.30 mm, p=0.40, distally: immediate vs. delayed: difference in mean 0.21

mm (95%CI -0.10 to 0.51 mm, p=0.58). No significant differences in the outcome variables

were observed.

Conclusion:

Immediate implant placement with delayed provisionalization was non-inferior to delayed

implant placement with delayed provisionalization in labial bony defects of ≥5 mm

regarding change in MBL. Although not powered for other outcome variables, no clinically

relevant differences were observed in these variables.

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Introduction

The survival of immediately placed and provisionalized implants in the aesthetic zone is very high.1,2,3

However, it is not just implant survival that determines the success of an implant treatment as implant

treatment in the aesthetic zone is also in need of a favourable hard and soft peri-implant tissue outcome.4,5

A recent randomized clinical trial6 verified this for marginal bone level (MBL) in extraction sockets with

no bony defects and showed that indeed the MBL outcome is favourable too. Although unknown to what

extent the peri-implant soft tissues react on missing support of hard peri-implant tissues, it has been

hypothesized that the risk on developing facial gingival recession is low when the bone labially from the

implants has no dehiscences and a sufficient thickness at implant placement.7 In this respect, it was

reported that large U- and UU-shaped defects are accompanied by more gingival recession 1-year after

immediate tooth replacement, reason why Kan et al8 recommended a delayed approach, viz. to combine

implant placement with hard and/or soft tissue grafting when a labial bone defect is present at implant

placement. Recently, however, it was reported that newer techniques allow for a favorable treatment

outcome of implants placed in fresh extractions sockets with labial plate dehiscences.9-11 Thus, an intact

labial plate is presumably not essential to allow for immediate implant placement with a favorable

outcome. No studies yet assessed the treatment outcome of implants placed in fresh extraction sockets

with labial plate dehiscences in the aesthetic zone in a prospective, randomized clinical trial design.

Therefore, the aim of this randomized controlled trial was to assess whether the 1 year treatment outcome

of immediate implant placement and delayed provisionalization is non-inferior regarding change in

marginal bone level (MBL) to delayed implant placement and delayed provisionalization in case of implant

placement in fresh extraction sockets with labial bony defects of ≥5 mm in the aesthetic zone.

Materials and methods

Study design

Between January 2010 and January 2012 all eligible consecutive patients >18 years with a failing tooth in

the maxillary aesthetic zone (incisor, canine or first premolar) referred for single tooth implant treatment

were asked to join this randomized clinical trial. Pre-operative, a cone beam computed tomography

(CBCT)-scan was made to assess whether there was sufficient bone on the palatal side to place an implant

as for primary stability of the implant sufficient palatinal bone is necessary in case of labial dehiscence.

Patients were excluded from participation in this study when they met one or more of the following criteria:

inadequate oral hygiene, insufficient mesio-distal width for implant placement, periodontal disease,

smoking, ASA (American Society of Anesthesiologists) score ≥II12, and a bony defect of <5 mm in vertical

direction of the labial socket wall after removal of the tooth. The size of the bony defect was determined

after extraction of the failing tooth. The shape of the osseous defect was assessed by a bone sounding

technique with a periodontal probe at the buccal, the mesial, and distal aspect of the failing tooth, and the

mesial and distal aspect of the immediately adjacent teeth.

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For allocation to either group a computerized random number generator was used. A research-nurse not

involved in the study blindly allocated the patients to (Figure 1 and 2):

- An immediate group: immediate placed implant (NobelActive, Nobel Biocare AB, Goteborg, Sweden)

and delayed provisionalization;

- A delayed group: delayed placed implant (NobelActive, Nobel Biocare AB, Goteborg, Sweden) and

delayed provisionalization.

Informed consent was obtained from all patients. The study was approved by the local medical ethical

committee (NL32240.042.10) and registered in a trial register (ISRCTN57251089).

Surgical protocol

Preoperatively, patients started prophylactic antibiotic therapy (amoxicillin 500mg t.i.d. for 7 days or

clindamycin 300mg q.i.d. in case of amoxicillin allergy). Oral disinfection consisted of a 0.2% chlorhexidine

mouthwash, twice daily for 7 days. All surgeries were performed under local anesthesia and performed

by the same experienced oral and maxillofacial surgeon (GR). In all cases, the failing teeth were removed

with a sulcular incision, careful detachment of the periodontal ligament and use of periotomes. After

removal of the tooth, the alveolus was meticulously cleansed and any alveolar debridement was removed

with a sterile gauze. If the sterile gauze was still contaminated, more cleaning took place. Before implant

placement, bone grafts were harvested from the maxillary tuberosity with the use of chisels. The wound of

the bone graft in the tuberosity region was closed with Vicryl 4-0 (Ethicon, Johnson&Johnson, Amersfoort,

The Netherlands).

Immediate placement group:

The implant site was prepared on the palatal side of the alveolus following the protocol of the manufacturer

using a surgical template based on the ideal position of the prospective implant crown. The last used burr,

depending on the diameter of the implant, was placed in the prepared alveolus. Next, the tuberosity bone

graft was shaped with the use of a forceps to match the labial bony defect. The bone graft was placed in the

extraction socket, with the cortical side facing the periosteum, under the periosteum covering the labial

plate defect. A mixture of autologous bone and Bio-Oss® (Geistlich, Wolhusen, Switzerland) spongiosa

granules (0.25-1.0 mm) was thightly packed into the remaining space between the burr and the bone

graft. Regarding the corono-apical position of the implants (NobelActive, Nobel Biocare AB, Goteborg,

Sweden) the shoulder of the implant was placed at a depth of 3 mm apical to the most apical aspect of

the prospective clinical crown, with help of the surgical template. Immediately after implant placement a

corresponding cover screw was placed. To achieve an optimal aesthetic outcome, next a soft tissue graft,

harvested from tuberosity region where the bone graft was taken from, was placed on top of the bone graft

and implant according to the method described in detail by Raghoebar et al.13 The wound was closed with

Ethilon 5-0 (Ethicon, Johnson&Johnson, Amersfoort, The Netherlands).

During the three months osseointegration phase, patients were allowed to wear a removable partial

denture not interfering with the wound. After three months, the implant was uncovered by a small

incision at the site of the cover screw, followed by an implant-level impression according to the procedure

described in the prosthetic protocol section.

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Figure 1. Cohort flow diagram.

Enrollment Assessed for eligibility (n=40)

Excluded (n=0) • Not meeting inclusion criteria (n=0) • Declined to participate (n=0) • Other reasons (n=0)

Allocated to intervention (n=20) • Received allocated intervention (n=20) • Did not receive allocated interven tion (give reasons) (n=0)

Lost to follow-up (give reasons) (n=0) Discontinued intervention (give reasons) (n=0)

Analysed (n=20) • Excluded form analysis (give reasons) (n=0)

Allocated to intervention (n=20) • Received allocated intervention (n=20) • Did not receive allocated interven tion (give reasons) (n=0)

Lost to follow-up (give reasons) (n=0) Discontinued intervention (give reasons) (n=0)

Analysed (n=20) • Excluded form analysis (give reasons) (n=0)

Randomized (n=40)

Allocation

Follow-Up

Analysis

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Figure 2A. Schedule of visits and procedures study group immediate placement and

delayed provisionalization.

Inclusion

Prosthetic phase

Healing phase

Follow-up phase

Pre-operative TPre

Screening and Measurements

Extraction &

Implant placement

& Delayed

provisionalization

Second phase surgery

& Provisional crown

Definitive crown and Follow-up

Day 0 (T0)

3 months (T3)

6 months (T6)

12 months (T12)

Follow-up

18 months (T18)

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Figure 2b. Schedule of visits and procedures study group delayed placement and

delayed provisionalization.

Inclusion

Prosthetic phase

Healing phase

Pre-operative TPre

Screening and Measurements

Extraction &

Guided Bone Regeneration

Implant placement

Second phase surgery

& Provisional crown

Definitive crown and Follow-up

Day 0 (T0)

3 months (T3)

6 months (T6)

9 months (T9)

12 months (T12)

Follow-up

21 months (T21)

18 months (T18)

Follow-up phase

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Delayed placement group:

The alveolus was locally augmented with the same procedure as described for the immediate group,

with exception of placement of an implant. After 3 months a pedicled mucoperiosteal flap was raised to

expose the maxilla, after which the NobelActive implant was placed according to the requirements of the

manufacture using a surgical template. The implants were placed, comparable to the implants placed in the

immediate placement group, 3 mm below the cervical junction of the adjacent teeth. The wound was primary

closed with Ethilon 5-0 (Ethicon, Johnson&Johnson, Amersfoort, The Netherlands). After three months

the implant was uncovered following the same procedure as described for the immediate group, again

followed by an implant-level impression. Patients were allowed to wear a removable partial denture until the

provisionalization took place.

Prosthetic protocol

An implant-level impression was made immediately after uncovering the implant. After the impression was

taken, a corresponding healing abutment was placed. A screw-retained provisional crown composed of

an engaging temporary abutment and composite was then fabricated in the dental laboratory. This same

day, the provisional crown was fastened directly onto the implant with 20 Ncm by a manual torque wrench.

A final open tray impression using polyether impression material (Impregum Penta, 3M ESPE, Seefeld,

Germany) was taken at implant level after a provisional phase of 3 months in both groups. In the dental

laboratory, one lab technician made the digital design of the definitive crown to the desired form of the

abutment. This digital design was used to retrieve individualized zirconia abutments (NobelProcera, Nobel

Biocare AB, Goteborg, Sweden). Depending on the location of the screw access hole, the final crown was

either cement-retained or screw-retained. Abutment screws were torqued with 32 Ncm. Cement-retained

crowns were cemented with glass ionomer cement (Fuji Plus, GC Europe, Leuven, Belgium). All prosthetic

procedures were performed by a single experienced prosthodontist (HM).

Outcome measures

Primary outcome measure of this study was the change in marginal peri-implant bone level (MBL) proximal

to the implant, from placement of the implant to one month (T1) after connecting the definitive crown and

from placement of the implant to one year (T12) after connecting the definitive crown.

Secondary outcome measures included buccal bone thickness (BBT), implant survival, change in

interproximal peri-implant mucosa (IML) and midfacial peri-implant mucosal level (MML) as compared

with the gingival level of the pre-operative failing tooth. Furthermore, papilla volume, health of keratinized

gingiva, amount of plaque, amount of bleeding and pocket probing depth were assessed. Aesthetic

outcome was assessed by means of objective indices (Implant Crown Aesthetic Index (ICAI)14, the pink

esthetic score (PES)15 and the white esthetic score (WES).16,17 Patients’ satisfaction was assessed using the

Oral Health Impact Profile (OHIP) index18 and the Visual Analogue Scale (VAS)19 on a 0-10 scale.

Radiographic assessments

To calculate changes in MBL, one month (T1) and one year (T12) after placement of the definitive crown,

a standardized digital peri-apical radiograph was taken with an individualized aiming device20, pre-

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operatively (Tpre), immediately following implant placement (baseline T0), one month (T1), and twelve

months (T12) after definitive crown placement. The vertical distance from the shoulder of the implant to the

first-bone-to-implant contact was measured at the distal and mesial site of the implant. The radiographs of

T1 and T12 were analyzed using the manufacturer-provided implant diameter as a reference. Measurements

were performed independently by two examiners (KS and Harry Slagter), after which the average of both

measurements was used.

To calculate buccal bone thickness (BBT) labial of the implant, one month (T1) and one year (T12) after

placement of the definitive crown a CBCT scan was made. The scanner (iCAT 3D exam scanner,KaVo Dental

GmbH, Biberach, Germany) was validated for measuring bone thickness by Fourie et al.21 To allow for

reproducible measurements, a CBCT imaging and software protocol was developed and validated.22 Area

of interest was the distance from the central axis of the implant to the outer contour of the buccal bone

at the neck of the implant. Buccal bone thickness measurements (in mm) were performed calculating the

distance to the buccal bone outline minus the radius of the interior contour of the implant (as provided by

the implant company). Measurements were performed independently by two examiners (KS and HM), after

which the average of both measurements was used.

Survival rate

Survival rate was defined as the percentage of functional implants one year after definitive crown

placement. The criteria for successful osseointegration according to Smith & Zarb (1989) were adapted.

Photographic assessments

Before implant placement (Tpre) at T1 and at T12, standardized digital photographs (Nikon D300s, Nikon

Corporation,Yurakucho, Tokyo, Japan) were taken using a technique as described earlier.17 A manual

periodontal probe (Williams Color-Coded probe; Hu-Friedy, Chicago, IL, USA) with known dimensions was

held in close proximity and parallel to the long axis of the adjacent tooth to calibrate the photographs. Full

screen analysis of the photographs was performed using a digital picture editing program (Keynote, Apple

Inc, Cupertino, CA, USA). The changes in IML and in MML were compared with the original gingival level

of the failing tooth. These measurements were independently performed by two examiners (KS and Harry

Slagter) after which the average of both measurements was used.

Clinical assessments

The following clinical variables were assessed at T1 and T12 at the implant and adjacent teeth before

implant placement (Tpre):

- Papilla volume: assessing the mesial and distal papilla adjacent to the implant using the papilla

index23;

- Amount of plaque: assessed at four sites per implant/adjacent tooth (mesial, buccal, distal and

palatinal) using the modified plaque index24;

- Amount of bleeding: using the modified sulcus bleeding index24;

- Gingiva: using the gingival Index25;

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- Probing pocket depth: assessed at four sites per implant/adjacent tooth (mesial, buccal, distal and

palatinal) using a manual periodontal probe (Williams Color-Coded probe; Hu-Friedy, Chicago, IL, USA)

measuring to the nearest 1 mm. All data were recorded by a single one blinded examiner (KS).

Aesthetic assessments

The aesthetic outcome was assessed on standardized digital photographs (Nikon D300s, Nikon

Corporation,Yurakucho, Tokyo, Japan taken at Tpre and T1, and T12 in both groups. An additional

photograph was taken of implant crowns replacing the lateral of canine capturing the contra lateral tooth.

Peri-implant mucosa and implant crown aesthetic outcomes were determined using ICAI14 and PES-WES.16,17

Measurements were performed independently by two examiners (KS and Diederik Hentenaar).

Patients’ satisfaction

Patients’ satisfaction was surveyed at T1 and T12 using the validated OHIP-14 questionnaire. Overall

satisfaction was assessed using a 100-mm visual analogue scale (VAS).

Statistical analysis

For determination of the sample size, G*power version 3.1 was used.26 A radiographic change in MBL of

>0.9 mm (SD 1 mm) after 12 months of definitive crown placement was regarded as a relevant difference

between study groups.1 With an expected effect-size of 0.9 mm, an alpha of 0.05 and a power of 0.80,

38 patients were required, 19 in each group. 40 patients were included to account for anticipated drop-

out rate. Shapiro-Wilk test, together with normality plots were used to assess normal distribution of

the continuous variables. Differences between groups were evaluated by one-way analyses of variance

(ANOVA) for continuous data and by Fisher’s exact test or chi-Square test for categorical data. Regarding

MBL, T-tests for equality of means with associated confidence intervals (CI) were calculated. If the

difference of 0.9 did not pass the 95% CI borders, non-inferiority was considered established. In case of

uncertainty of the significance because of the relatively small number of patients analysed and the large

number of outcomes, Bonferroni correction was considered in case of a p-value 0.01<>0.05. A p-value of

0.05 was considered to indicate statistical significance. All analyses were performed using SPSS (PASW

Statistics 20.0, SPSS Inc.; IBM Corporation, Chicago, IL, USA).

Results

Inter-and intra-observer correlation

The inter- and intra-observer correlations for both the radiographic and photographic measurements were

very high. For details see Slagter et al.6

Patients

Baseline characteristics and treatment specifications of the immediate group (n=20) and delayed group

(n=20) are shown in Table 1 and Figure 3 and 4. All patients received their assigned treatment (Figure 1).

No extensive bleedings at the donor and receptor site were observed.

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Table 1. Baseline characteristics and treatment specifications per study group.

Variable Immediate group (n=20)

Delayed group (n=20)

Age Mean±SD Range

43.7 ±13.9 18-63

48.6 ±16.4 20-72

Gender Male Female

11 9

7 13

Cause of tooth loss

Fracture (crown or root) Agenesis Caries Endodontic failure Periodontal failure Root resorption

9 0 0 8 0 3

9 0 1 5 2 3

Bone defect Mean±SD (mm) 8.35 ±2.18 8.65 ±1.76

Implant locationIncisor 1 Incisor 2 Canine

12 5 3

14 6 0

Implant length13 mm 15 mm 18 mm

1 12 7

6 10 4

Implant diameter 3.5 mm 4.3 mm

5 15

5 15

Type of final restoration Screw-retained Cement-retained

14 6

12 8

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Three patients (immediate: group 1; delayed: group 2) had an antral perforation due to harvesting

the tuberosity bone. The wound overlying the antral perforation was primary closed and healing was

uneventful. Wound healing at the grafting/implantation site was undisturbed with the exception of

one patient (group 2) in whom a small bone sequester had to be removed. After removal of the bone

sequester, wound healing was uneventful and the remaining bone was sufficient for implant placement. No

complications were observed during the follow up.

Marginal bone level

MBL loss at the mesial and distal site after 1 month and 12 months after placement of the definitive crown

was comparable for both treatment approaches (Table 2). Non-inferiority for the change in MBL between

the groups was observed, both for the 1 month (mesially: immediate group vs. delayed group: difference in

mean 0.04 mm (95%CI-0.24- to 0.23 mm, p=0.83, distally: 0.23 mm (95%CI-0.84 to 0.54 mm, p=0.70) and

1 year (mesially: 0.04 mm (95%CI -0.22 to 0.30, p=0.40, distally: 0.21mm (95%CI -0.10 to 0.51 mm, p=0.58)

time point.

Buccal bone level

Mean buccal bone thickness at the neck of the implant 1 month and 12 months after placement of the

definitive crown is shown in Table 2. Buccal bone thickness did not change between between T1 and T12.

Survival rate

One year implant survival rate was 100% in both groups.

Interproximal and midfacial peri-implant mucosal level

IML and MML, did not change significantly between with time in both groups (Table 2).

Clinical outcome

Plaque, bleeding and gingival indexes as well as the pocket probing depth were low and remained low

throughout the study period (Table 3).

Aesthetic assessments

At the 1-year evaluation, no significant differences in ICAI as well as PES/WES were seen between the

groups (Table 2). The aesthetic outcome was mainly dependent on the appearance of the implant crown

and less by the aspect of the peri-implant mucosa, and did not differ between the groups.

Patients’ satisfaction

OHIP-14 scores did not differ between the groups (Table 4; p>0.05). Overall satisfaction scores one year

after placement of the crown were 8.4±1.4 and 8.1±1.3 for the immediate and delayed group, respectively.

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Table 2. Changes regarding marginal bone level, marginal soft tissue level and aesthetic evaluation from pre-operative (Tpre), one month (T1) to 12 months (T12) after definitive crown placement.

Tpre Tpre P-value T1 T1 P-value T12 T12 P-value

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Mean (sd)

Variable

Group A

Group B

Group A

Group B

Group A

Group B

Marginal bone level in mm(±sd)

Mesial of implant 0.49 (±0.46)

0.45 (±0.41) 0.79 0.56

(±0.39)0.51 (±0.43) 0.74

Distal of implant 0.71 (±0.51)

0.48 (±0.47) 0.15 0.74

(±0.51)0.54 (±0.45) 0.18

BBTchanges in mm Buccal of implant (mean ±sd)

1.01 (±0.55)

0.79 (±0.46) 0.19 1.00

(±0.47)0.71 (±0.28) 0.07

Marginal soft tissue level changes in mm (±sd)

Mesial of implant 0.15 (±0.18)

0.18 (±0.16) 0.73 0.15

(±0.16)0.15 (±0.16) 0.99

Distal of implant 0.17 (±0.16)

0.23 (±0.17) 0.32 0.18

(±0.18)0.21 (±0.17) 0.53

Mid-facial of implant 0.13 (±0.28)

0.30 (±0.49) 0.20 0.15

(±0.28)0.34 (±0.55) 0.17

PES 7.00 (2.10)

6.90 (1.30) 0.63 7.80

(1.66)7.40 (1.59) 0.71 7.50

(1.59)7.40 (1.46) 0.79

WES 5.00 (2.33)

5.40 (1.65) 0.70 7.99

(1.73)7.60 (1.09) 0.68 8.10

(0.90)7.90 (1.08) 0.79

PES/WES 10.68 (3.40)

11.10 (3.46) 0.43 16.20

(2.20)15.10 (1.71) 0.38 15.80

(2.05)15.30 (2.11) 0.50

ICAI 9.60 (6.54)

14.10 (8.57) 0.23 3.80

(2.18)6.20 (3.94) 0.35 4.20

(2.38)5.2 (4.10) 0.37

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3b

3a

3c

3b

3d

Figure 3. Immediate implant treatment with delayed provisionalization.

a Clinical situation pre-operative.

b. Pre-operative radiograph.

c. Clinical situation post-operative.

d. Post-operative radiograph.

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4a

4c

4b

4d

Figure 4. Delayed implant treatment with delayed provisionalization.

a Clinical situation pre-operative.

b. Pre-operative radiograph.

c. Clinical situation post-operative.

d. Post-operative radiograph.

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Table 3. Clinical outcome measures pre-operative (Tpre), and one month (T1) and 12 months (T12) after definitive crown placement.

Tpre Tpre P- value T1 T1 P-

value T12 T12 P- value

Variable

Immediate group

Delayed group

Immediate group

Delayed group

Immediate group

Delayed group

Papilla index: 0/1/2/3/4

Mesial (#patient) 0/7/2/11/0 2/6/6/6/0 0.17 1/5/3/11/0 2/8/4/6/0 0.45 0/3/8/9/0 0/6/5/9/0 0.43

Distal (#patient) 0/7/5/8/0 2/6/6/6/0 0.53 1/5/8/6/0 5/6/5/4/0 0.28 0/3/8/9/0 0/7/7/6/0 0.32

Gingival index: 0/1/2/3 (#patient)

19/1/0/1 17/1/1/1 0.55 18/2/0/0 20/0/0/0 0.35 18/2/0/0 20/0/0/0 0.24

Plaque index: 0/1/2/3 (#patient)

18/2/0/0 20/0/0/0 0.47 20/0/0/0 20/0/0/0 NA 18/1/1/0 20/0/0/0 0.35

Bleeding index: 0/1/2/3 (#patient)

9/9/2/0 9/6/3/2 0.39 11/7/1/0 12/8/0/0 0.59 11/9/0/0 15/5/0/0 0.16

Pocket depth in mm

Mesial (mean ±sd) 3.0±1.7 3.3± 1.7 0.51 3.1± 0.6 3.2± 0.7 0.80 3.3±0.7 3.6±0.8 0.27

Distal (mean ±sd) 3.3±1.1 3.6±1.6 0.43 3.6±0.7 3.3±0.7 0.25 3.5±0.8 3.8±0.8 0.33

Buccal (mean ±sd) 1.6±0.8 2.3±1.2 0.10 2.8±0.8 3.3±0.9 0.17 3.2±0.8 3.3±0.7 0.53

Palatal (mean ±sd) 2.2±0.9 2.9±1.9 0.12 2.8±0.4 2.9±0.6 0.76 2.7±0.6 3.1±0.5 0.09

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Table 4. Oral Health Impact Profile18scores at baseline (T1) and one year (T12) of functioning.

Mean OHIP-14 T1 P-value T12 P-value

Immediate group Delayed group

Immediate group Delayed group

Variable

never/hardly ever/occasionally/fairly often/very often

never/hardly ever/occasionally/fairly often/very often

Question 1 Have you had trouble pronouncing any words because of problems with your teeth, mouth or dentures?

0/17/3/0/0 0/14/5/1/0 0.41 0/19/1/0/0

0/16/3/1/0 0.32

Question 2 Have you felt that your sense of taste has worsened because of problems with your teeth, mouth or dentures?

0/18/2/0/0 0/16/2/2/0 0.35 0/19/1/0/0

0/18/1/1/0 0.60

Question 3 Have you had a painful aching in your mouth?

0/11/7/2/0 0/9/10/1/0 0.59 0/9/9/2/0

0/10/8/2/0 0.95

Question 4 Have you found it uncomfortable to eat any foods because of problems with your teeth, mouth or dentures?

0/12/7/1/0 0/11/5/4/0 0.34 0/16/3/1/0

0/16/2/2/0 0.77

Question 5 Have you been self-conscious of your teeth, mouth or dentures?

0/10/4/4/2 0/11/4/5/0 0.54 0/13/4/3/0

0/15/3/1/0 0.53

Question 6 Have you felt tense because of problems with your teeth, mouth or dentures?

0/12/5/3/0 0/14/3/3/0 0.72 0/11/5/4/0

0/16/1/3/0 0.15

Question 7 Has your diet been unsatisfactory because of problems with your teeth, mouth or dentures?

0/17/3/0/0 0/16/4/0/0 0.68 0/19/1/0/0

0/16/4/0/0 0.17

Question 8 Have you had to interrupt meals because of problems with your teeth, mouth or dentures?

0/18/2/0/0 0/18/2/0/0 1.00 0/18/2/0/0

0/20/0/0/0 0.24

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Question 9 Have you found it difficult to relax because of problems with your teeth, mouth or dentures?

0/14/1/5/0 0/17/2/1/0 0.38 0/16/3/1/0

0/17/3/0/0 0.60

Question 10 Have you been a bit embarrassed because of problems with your teeth, mouth or dentures?

0/15/5/0/0 0/13/6/1/0 0.54 0/17/2/1/0

0/13/3/1/1 0.54

Question 11 Have you been a bit irritable with other people because of problems with your teeth, mouth or dentures?

0/16/2/2/0 0/17/2/0/0 0.37 0/15/5/0/0

0/16/2/2/0 0.19

Question 12 Have you had difficulty doing your usual jobs because of problems with your teeth, mouth or dentures?

0/11/7/1/1 0/12/7/1/0 0.79 0/17/3/0/0

0/16/3/1/0 0.60

Question 13 Have you felt that life in general was less satisfying because of problems with your teeth, mouth or dentures?

0/14/4/1/0 0/15/3/2/0 0.68 0/18/1/1/0

0/18/1/1/0 1.00

Question 14 Have you been totally unable to function because of problems with your teeth, mouth or dentures?

0/19/1/0/0 0/20/0/0/0 0.31 0/19/0/1/0

0/17/3/0/0 0.13

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Discussion

The present study showed that immediate placement with delayed provisionalization was not inferior

to delayed placement with delayed provisionalization at a level of >0.9 mm MBL. Although not a priori

powered to compare the other outcome variables, no clinically relevant differences were observed

regarding clinical, esthetic and patient-reported outcomes too. Immediate placement offers a shorter

treatment time due to the lower number of surgical procedures by combining extraction, implant

placement, and bone grafting in one operative procedure.27-29

Clinical outcomes

Change in MBL in this study is considerably less than the generally accepted magnitude of up to 1 mm for

the first year after implant placement described in the systematic review of Lang et al.1 and the 0.81±0.48

mm according to the systematic review of Slagter et al.3 concerning immediate implant placement. It has

to be mentioned that MBL loss usually predominantly occurs during the first year after immediate implant

placement and hardly progresses thereafter.1 Thus, the 1-year results are considered to reflect the level

of MBL related to a specific treatment in healthy subjects, a result that supports the immediate implant

placement approach.

A successful aesthetic outcome is presumably dependent on establishment of an optimal three-

dimensional implant position within the available bone dimensions as well as the maintenance of

adequate buccal bone over the buccal implant surface.30,31 In the present study, the buccal bone thickness

appeared at least to be stable up to 1 year after implant placement and provisionalization in both patient

groups and was thus considered to be independent of timing of implant insertion. Literature regarding

BBT is scarce. Comparison with other studies, although measured in a different study design, learned that

in the present study BBT after 1 year for immediate placed implants was more than the value of 0.16 mm

thickness reported in the immediate implant group of Raes et al.32 but less than the 2.12 mm BBT reported

by Degidi et al.33 For the delayed placed implants, BBT in the present study was more than the 0.20 mm

reported by Raes et al.32

Regarding the peri-implant soft tissues, the phenomenon biotype has been reported to affect the aesthetic

result.34 Possibly the thickness of the mucosa can positively influence the stability of the peri-implant soft

tissues. In future studies, the effect of biotype on treatment outcome should be an integral part of the

treatment design.

Aesthetic assessments

Although not upfront powered, the PES/WES and ICAI scores were comparable for the studied approaches

and were comparable to results published in the literature regarding immediately and delayed placed

single tooth implants placed in the aesthetic zone.16,35,36 The scores of the pink component of PES/WES

and ICAI were favorable and comparable for the immediate and delayed approaches, again supporting

immediate placement of implants in larger bony defects when primary stability of the implant can be

achieved.

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Patients’ satisfaction

In the field of implant dentistry there is an increasing focus on patient-reported outcome measures.37

Immediate placement with immediate provisionalization is associated with high satisfaction rates.38 This

is in line with the satisfaction perceived by patients with immediate implant placement in this study.

Regarding the OHIP-14, no differences were observed between both groups during the entire follow-up,

again in line with other studies regarding immediate implant placement.39,40 The two protocols, while

yielding comparable results in terms of clinical outcomes and patient satisfaction, differed considerably

in time to teeth and the number of scheduled visits (Figure 2), with the immediate implant placement

reducing both the time and visit number to final restoration.

Limitation

The procedure to replace a failing tooth in the aesthetic zone with a bony defect with an immediate implant

is a complex procedure. Raghoebar et al13 showed that gingival mid-labial aesthetics most benefitted from

a full thickness palatal graft compared to a connective tissue graft or closing with a membrane. Due to the

complexity of this procedure, to achieve an optimal result it was recommended that the surgery should be

done by experienced surgeons.13 Therefore, in the current study all surgeries were performed by one single

experienced surgeon. The latter approach compromises the applicability of the reported approach for

general applications.

Conclusion

Immediate placement with delayed provisionalization is non-inferior regarding a change in MBL of >0.9

mm to delayed placement with delayed provisionalization in labial bony defects of ≥5 mm in the aesthetic

zone after a 1-year follow-up. In addition, although not powered for these outcome variables, no clinically

relevant differences in other outcomes were observed.

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systematic review on survival and success

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compromised sockets: a novel technique. Eur J

Esthet Dent 2013;8:432-443.

11. Ahead of print. Sarnachiaro GO, Chu SJ,

Sarnachiaro E, Gotta SL, Tarnow DP. Immediate

implant placement into extraction sockets with

labial plate dehiscence defects: a clinical case

series. [published online ahead of print April

27, 2015]. Clin Implant Dent Relat Res 2015; doi:

10.1111/cid.12347

12. Little JP. Consistency of ASA grading.

Anaesthesia 1995;50:658-659.

13. Raghoebar GM, Slater JJ, Hartog L, Meijer

HJ, Vissink A. Comparison of procedures for

immediate reconstruction of large osseous

defects resulting from removal of a single tooth

to prepare for insertion of an endosseous

implant after healing. Int J Oral Maxillofac Surg

2009;38:736-743.

14. Meijer HJ, Stellingsma K, Meijndert L, Raghoebar

GM. A new index for rating aesthetics of

implant-supported single crowns and adjacent

soft tissues - the Implant Crown Aesthetic Index.

Clin Oral Implants Res 2005;16:645-649.

15. Furhauser R, Florescu D, Benesch T, Haas R,

Mailath G, Watzek G. Evaluation of soft tissue

around single-tooth implant crowns: the

pink esthetic score. Clin Oral Implants Res

2005;16:639-644.

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16. Belser UC, Grutter L, Vailati F, Bornstein MM,

Weber HP, Buser D. Outcome evaluation of

early placed maxillary anterior single-tooth

implants using objective esthetic criteria:

a cross-sectional, retrospective study in 45

patients with a 2- to 4-year follow-up using

pink and white esthetic scores. J Periodontol

2009;80:140-151.

17. Buser D, Halbritter S, Hart C, et al. Early implant

placement with simultaneous guided bone

regeneration following single-tooth extraction

in the esthetic zone: 12-month results of a

prospective study with 20 consecutive patients.

J Periodontol 2009;80:152-162.

18. van der Meulen MJ, John MT, Naeije M,

Lobbezoo F. Developing abbreviated OHIP

versions for use with TMD patients. J Oral

Rehabil 2012;39:18-27.

19. Carlsson AM. Assessment of chronic pain. I.

Aspects of the reliability and validity of the

visual analogue scale. Pain 1983;16:87-101.

20. Meijndert L, Meijer HJ, Raghoebar GM, Vissink

A. A technique for standardized evaluation

of soft and hard peri-implant tissues in

partially edentulous patients. J Periodontol

2004;75:646-651.

21. Fourie Z, Damstra J, Schepers RH, Gerrits PO,

Ren Y. Segmentation process significantly

influences the accuracy of 3D surface

models derived from cone beam computed

tomography. Eur J Radiol 2012;81:e524-30.

22. Online-only article. Slagter KW, Raghoebar GM,

Vissink A, Meijer HJA. Inter- and intraobserver

reproducibility of buccal bone measurements

at dental implants with cone beam computed

tomography in the esthetic region. International

Journal of Implant Dentistry 2015, 1:8;

doi:10.1186/s40729-015-0007-1.

23. Jemt T. Regeneration of gingival papillae after

single-implant treatment. Int J Periodontics

Restorative Dent 1997;17(4):326-333.

24. Mombelli A, van Oosten MA, Schurch E,Jr, Land

NP. The microbiota associated with successful

or failing osseointegrated titanium implants.

Oral Microbiol Immunol 1987;2:145-151.

25. Löe H. The Gingival Index, the Plaque Index and

the Retention Index Systems. J Periodontol.

1967;38:610–616.

26. Faul F, Erdfelder E, Buchner A, Lang AG.

Statistical power analyses using G*Power 3.1:

tests for correlation and regression analyses.

Behav Res Methods 2009;41:1149-1160.

27. De Rouck T, Collys K, Cosyn J. Single-tooth

replacement in the anterior maxilla by means of

immediate implantation and provisionalization:

a review. Int J Oral Maxillofac Implants

2008;23:897-904.

28. De Rouck T, Collys K, Wyn I, Cosyn J. Instant

provisionalization of immediate single-tooth

implants is essential to optimize esthetic

treatment outcome. Clin Oral Implants Res

2009;20:566-570.

29. den Hartog L, Raghoebar GM, Stellingsma K,

Vissink A, Meijer HJ. Immediate non-occlusal

loading of single implants in the aesthetic

zone: a randomized clinical trial. J Clin

Periodontol 2011;38:186-194.

30. Buser D, Martin W, Belser UC. Optimizing

esthetics for implant restorations in the

anterior maxilla: anatomic and surgical

considerations. Int J Oral Maxillofac Implants

2004;19.

31. Grunder U, Gracis S, Capelli M. Influence of the

3-D bone-to-implant relationship on esthetics.

Int J Periodontics Restorative Dent 2005;25:113-

119.

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32. Raes F, Renckens L, Aps J, Cosyn J, De Bruyn

H. Reliability of circumferential bone level

assessment around single implants in healed

ridges and extraction sockets using cone beam

CT. Clin Implant Dent Relat Res 2013;15:661-

672.

33. Degidi M, Daprile G, Nardi D, Piattelli A.

Immediate provisionalization of implants

placed in fresh extraction sockets using a

definitive abutment: the chamber concept. Int J

Periodontics Restorative Dent 2013;33:559-565.

34. Kan JY, Rungcharassaeng K, Lozada JL,

Zimmerman G. Facial gingival tissue

stability following immediate placement and

provisionalization of maxillary anterior single

implants: a 2- to 8-year follow-up. Int J Oral

Maxillofac Implants 2011;26:179-187.

35. den Hartog L, Raghoebar GM, Slater JJ,

Stellingsma K, Vissink A, Meijer HJ. Single-

tooth implants with different neck designs:

a randomized clinical trial evaluating the

aesthetic outcome. Clin Implant Dent Relat Res

2013;15:311-321.

36. Santing HJ, Raghoebar GM, Vissink A, den

Hartog L, Meijer HJ. Performance of the

Straumann Bone Level Implant system

for anterior single-tooth replacements in

augmented and nonaugmented sites: a

prospective cohort study with 60 consecutive

patients. Clin Oral Implants Res 2013;24:941-

948.

37. McGrath C, Lam O, Lang N. An evidence-based

review of patient-reported outcome measures

in dental implant research among dentate

subjects. J Clin Periodontol 2012;39:193-201.

38. Hartlev J, Kohberg P, Ahlmann S, Andersen

NT, Schou S, Isidor F. Patient satisfaction and

esthetic outcome after immediate placement

and provisionalization of single-tooth implants

involving a definitive individual abutment. Clin

Oral Implants Res 2014;25:1245-1250.

39. Raes F, Cooper LF, Tarrida LG, Vandromme H, De

Bruyn H. A case-control study assessing oral-

health-related quality of life after immediately

loaded single implants in healed alveolar

ridges or extraction sockets. Clin Oral Implants

Res 2012;23:602-608.

40. Raes F, Cosyn J, De Bruyn H. Clinical, Aesthetic,

and Patient-Related Outcome of Immediately

Loaded Single Implants in the Anterior Maxilla:

A Prospective Study in Extraction Sockets,

Healed Ridges, and Grafted Sites. Clin Implant

Dent Relat Res 2013;15:819-835.

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5Inter- and intraobserver

reproducibility of buccal bone

measurements at dental implants

with cone beam computed

tomography in the aesthetic region.

This chapter is an edited version of the manuscript:Slagter KW, Raghoebar GM, Vissink A, Meij er HJA.

Inter- and intra-observer reproducibility of buccal bone measurements at dental implants with cone beam computed tomography in the esthetic region.

International Journal of Implant Dentistry 2015, 1:8; doi:10.1186/s40729-015-0007-1.

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Abstract

Background:

Sufficient buccal bone is important for optimal aesthetic results of implant treatment in

the anterior region. It can be measured with cone beam computed tomography (CBCT),

but background scattering and problems with standardization of the measurements are

encountered. The aim was to develop a method for reliable, reproducible measurements on

CBCTs.

Materials and Methods:

Using a new method, buccal bone thickness was measured on 10 CBCTs at 6 positions

along the implant axis. Inter- and intra-observer reproducibility was assessed by repeated

measurements by two examiners.

Results:

Mean buccal bone thickness measured by observer one and two was 2.42 mm (sd:0.50) mm

and 2.41 mm (sd:0.47), respectively. Interobserver intraclass correlation coefficient was 0.96

(95%CI 0.93-0.98). The mean buccal bone thickness of the first measurement and the second

measurement of observer one was 2.42 mm (sd:0.50) and 2.53 mm (sd:0.49), respectively,

with an intra-observer intraclass correlation coefficient of 0.93 (95%CI 0.88-0.96). The mean

buccal bone thickness of the first measurement and the second measurement of observer

two was 2.41 mm (sd:0.47) and 2.52 mm (sd:0.47), respectively, with an intra-observer

intraclass correlation coefficient of 0.96 (95%CI 0.93-0.97).

Conclusion:

Applying the methods used in this study, CBCTs are suitable for reliable and reproducible

measurements of buccal bone thickness at implants.

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Introduction

Single-tooth implant placement in the aesthetic zone is a highly reliable treatment option for replacing a

failing tooth.1-4 Yet, research interest has shifted from implant survival towards optimal preservation of soft

and hard peri-implant tissues.5-7 Especially in the aesthetic region, buccal bone and its preservation is one

of the key factors in aesthetic outcome.8 Computerized tomography (CT) scans and cone beam CTs (CBCTs)

are commonly used for presurgical planning and to predict bone density and potential stability of dental

implants.9 Next to this, CTs and CBCTs also allow for measuring bone at dental implants during follow-

up.10,11 The quality and accuracy of a three-dimensional (3D) model derived from a (CB)CT is dependent on

scanner related factors such as type of scanner, field of view (FoV), artifacts and voxel size.12 In addition,

patient related factors such as patient position and metal artifacts13, and operator related factors as the

segmentation process or interpretation of the (CB)CT are of influence.14 It has been reported that buccal

bone thickness at implant sites can be measured with CBCT, but background scattering and problems with

standardization of the measurements are frequently encountered.15 In view of the aforementioned, there is

need for a reliable, reproducible method to facilitate measurements. The use of 3D image diagnostic and

treatment planning software programs in combination with software programs for tracking and registration

of the exact position of existing dental implants in radiographs can be of help.16

The aim of the current study was to develop a reproducible method based on 3D image diagnostic and

treatment planning software programs for buccal bone measurements at implants on CBCTs.

Materials and Methods

Ten patients with a dental implant in the aesthetic zone (region 13 to 23) were included. Patients were part

of a randomized controlled trial on aesthetics; the study was approved by the local Medical Ethic Board

(METC 2010.246) as well as that written informed consent was obtained from all patients. The CBCT scans

were made with an iCAT 3D exam scanner (KaVo Dental GmbH, Biberach, Germany), which scanner was

validated for measuring bone thickness by Fourie et al.17 The method error of this scanner is very small,

i.e. 0.05 mm (95 CI 0.03-0.07). The standard used voxel size was 0.30 and FoV was 100 x100 mm on the

CBCT scans. Bone measurements at implants on the CBCT scans was done using 3D image diagnostic and

treatment planning software (Nobelclinician, version 2.1 (Nobel Biocare - Guided Surgery Center, Mechelen,

Belgium). A novelty is that this program, regularly used pre-operatively, was employed to measure the

buccal bone thickness (in mm), after implant surgery. To allow for reproducible measurements, a CBCT

imaging and software protocol was developed.

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Table 1. Flow diagram of CBCT imaging and measurements to calculate bone thickness buccally of implants.

CBCT of patient

Determination and registration of position of implant with MIRIT

Measurements from central axis of planning implant to outer contour of buccal bone with Measurement

Tool in Nobelclinician

Import of patient DICOM-file and implant DICOM-file into Maxilim

Alignment of planning implant and registered implant with Research Tool

in Nobelclinician

Import of patient DICOM-file into Nobelclinician

Calculation of buccal bone thickness by substraction of radius of implant

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CBCT imaging and software protocol

Acquired CBCT Digital Imaging and Communications in Medicine (DICOM) datasets were transferred to a

computer. The CBCT images were exported in DICOM multi-file format and imported into Maxilim, version

2.3 (Medicim, Sint-Niklass, Belgium). Maxilim is a medical image computing program assessing the

patients head anatomy and is used for diagnostics and preoperative planning of maxillofacial surgery. The

input information for Maxilim is a 3D dataset, often (CB)CT data. The DICOM files of all patients were set

continuously on Hounsfield Unit (HU) isovalue 280. The implant used was set on HU isovalue 130. With

Multimodality Image Registration using Information Theory (MIRIT), which has an accuracy of a subvoxel,

the exact position of the implant could be recognized, determined and implemented in the patients DICOM

files16. The MIRIT procedure is based on recognizing image similarities. The degree of similarity between

intensity patterns in two images is determined and, consequently, the recognized image is registered

automatically into one coordinate system. Image similarities are broadly used in medical imaging to

enhance diagnostics. In the software program Nobelclinician, the patients DÌCOM files were opened with

the same HU isovalue of 280. An extra research tool was added to this software program by the program

makers, so that the DICOM file from Maxilim was recognized by this program and the exact position of the

implant, as determined in Maxilim, could be aligned with a planning implant in NobelClinician. Due to

the alignment of a planning implant (with a known configuration) and an actual inserted implant into one

image, measurements could take place at the exact buccal midline of the implant (Figure 1). The display of

the implant and surrounding structures was set on bone value, so that the outline of the bony structures

could be seen and measured. The buccal bone measurements at midline of the implant were performed

with the standard provided measurement tools in the software program of Nobelclinician.

Measuring procedure

The implant and patient dataset were exactly aligned by the MIRIT method, so that the distance from the

central axis of the implant to the outer contour of the buccal bone could be measured. Area of interest

was the upper 5mm section of the implant, beginning at the neck of the implant towards the apical

direction. Exact dimensions along the implant axis of each implant configuration used in the study was

provided by the manufacturer. Buccal bone measurements (in mm) were performed calculating the

distance to the buccal bone outline minus the radius of the interior contour of the implant. These buccal

bone measurements were done for 5 mm at each millimeter along the axis, beginning at the neck of the

implant (Figure 2). Measurements were repeated twice (with time interval to prevent recollection) by two

independent operators (HM and KS) in a random order. Flow diagram of the consecutive steps has been

depicted in Table 1.

Statistical analysis

Continuous variables were expressed as a mean with standard deviation. Interobserver and intra-observer

variability was assessed using two-way mixed intraclass correlation coefficient single measures analysis18.

All analyses were performed using SPSS software (version 20.0).

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Figure 1. Due to the alienation of the patients` DÌCOM fi les by MIRIT, the exact position of the implant was defi ned. As

such, the measurements could take place in the exact correct buccal direction.

Figure 1. Due to the alienation of the patients` DÌCOM fi les by MIRIT, the exact position of the implant was defi ned. As such, the measurements could take place in the exact correct buccal direction.

Figure 2. Measurements were performed at each millimeter along the axis of the implant for

5mm, beginning at the neck of the implant.

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Results

The mean buccal bone thickness measured by observer one and two was 2.42 mm (sd:0.50) and 2.41

mm (sd:0.47), respectively. Interobserver intraclass correlation coefficient was 0.96 (95%CI 0.93-0.98).

The mean buccal bone thickness of the first measurement and the second measurement of observer one

was 2.42 mm (sd:0.50) and 2.53 mm (sd:0.49), respectively, with an intra-observer intraclass correlation

coefficient of 0.93 (95%CI 0.88-0.96). The mean buccal bone thickness of the first measurement and the

second measurement of observer two was 2.41 mm (sd:0.47) and 2.52 mm (sd:0.47), respectively, with

an intra-observer intraclass correlation coefficient of 0.96 (95%CI 0.93-0.97).

Discussion

Intra-observer and interobserver agreement was very high with measurements on CBCTs of bone buccally

of dental implants. Apparently, the method is clear and measurements can be performed reproducibly.

Moreover, measurements are not observer dependent, meaning that results of different observers in

different studies can be compared with each other. In previous studies buccal bone thickness was

also measured, but the exact position of these measurements at the surface of the implant was not

determined by 3D image-based diagnostic and treatment planning software programs.10,11,15 It is important

to perform measurements of bone thickness at the same position at implants to make comparison in

time possible. Because of the cylindrical contour of the implant, thickness of bone can vary considerably

in the mesio-distal direction. The combination of the software programs MIRIT (for determination and

registration of the implant position in Maxilim) and Research Tool in Nobelclinician (for alignment of

planning implant and registered implant) makes the method reproducible.

Scattering of the titanium dental implant makes it difficult to perform measurements from the bone-

to-implant boundary to the buccal outer contour of the bone19. The combination of Research Tool in

Nobelclinician (exact positioning of the planning implant) and Measurement Tool in Nobelclinician

(for measurements from central axis of the implant) makes it possible to bypass the scattering area.

Measurements are corrected by subtraction of the known radius of implant, resulting in the actual

thickness of bone. Measurements are not directly possible in NobelClinician, because the image

recognizing program MIRIT can only be executed in the configuration of Maxilim. It would be desirable if

the total procedure could be carried in one program, being NobelClinician.

Conclusions

When applying 3D image-based software programs according to the set-up used in this study, CBCTs are

suitable for reliable and reproducible measurements of buccal bone thickness at implants.

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List of abbreviations

CBCT: Cone Beam Computed Tomography

CT: Computerized Tomography

FoV: Field of View

3D: three-Dimensional

DICOM: Digital Imaging and Communications in Medicine

HU: Hounsfi eld Unit

MIRIT: Multimodality Image Registration using Information Theory

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109

References

1. Den Hartog L, Slater JJ, Vissink A, Meijer

HJ, Raghoebar GM. Treatment outcome of

immediate, early and conventional single-tooth

implants in the aesthetic zone: a systematic

review to survival, bone level, soft-tissue,

aesthetics and patient satisfaction. J Clin

Periodontol. 2008;35:1073-86.

2. De Rouck T, Collys K, Cosyn J. Single-tooth

replacement in the anterior maxilla by means of

immediate implantation and provisionalization:

a review. Int J Oral Maxillofac Implants.

2008;23:897-904.

3. Esposito M, Grusovin MG, Polyzos IP, Felice P,

Worthington HV. Timing of implant placement

after tooth extraction: immediate, immediate-

delayed or delayed implants? A Cochrane

systematic review. Eur J Oral Implantol.

2010;3:189-205.

4. Jung RE, Zembic A, Pjetursson BE, Zwahlen M,

Thoma DS. Systematic review of the survival

rate and the incidence of biological, technical,

and aesthetic complications of single crowns on

implants reported in longitudinal studies with

a mean follow-up of 5 years. Clin Oral Implants

Res. 2012;23( Suppl 6):2-21.

5. Hammerle CH, Araujo MG, Simion M, Osteology

Consensus Group 2011. Evidence-based

knowledge on the biology and treatment of

extraction sockets. Clin Oral Implants Res.

2012;23(Suppl 5):80-2.

6. Botticelli D, Berglundh T, Lindhe J. Hard-tissue

alterations following immediate implant

placement in extraction sites. J Clin Periodontol.

2004;31:820-8.

7. Jemt T. Regeneration of gingival papillae after

single-implant treatment. Int J Periodontics

Restorative Dent. 1997;17:326-33.

8. Meijer HJ, Stellingsma K, Meijndert L, Raghoebar

GM. A new index for rating aesthetics of implant-

supported single crowns and adjacent soft

tissues - the Implant Crown Aesthetic Index. Clin

Oral Implants Res. 2005;16:645-9.

9. Sennerby L, Andersson P, Pagliani L, Giani C,

Moretti G, Molinari M, Motroni A. Evaluation

of a Novel Cone Beam Computed Tomography

Scanner for Bone Density Examinations in

Preoperative 3D Reconstructions and Correlation

with Primary Implant Stability. Clin Implant Dent

Relat Res. 2015;17(5):844-53.

10. Kan JY, Roe P, Rungcharassaeng K, Patel RD, Waki

T, Lozada JL, Zimmerman G. Classification of

sagittal root position in relation to the anterior

maxillary osseous housing for immediate

implant placement: a cone beam computed

tomography study. Int J Oral Maxillofac Implants.

2011;26:873-6.

11. Miyamoto Y, Obama T. Dental cone beam

computed tomography analyses of

postoperative labial bone thickness in maxillary

anterior implants: comparing immediate and

delayed implant placement. Int J Periodontics

Restorative Dent. 2011;31:215-25.

12. Kamburoglu K, Murat S, Kilic C, Yuksel S,

Avsever H, Farman A, et al. Accuracy of

CBCT images in the assessment of buccal

marginal alveolar peri-implant defects: effect

of field of view. Dentomaxillofac Radiol.

2014;43:20130332.

13. Ritter L, Mischkowski RA, Neugebauer J,

Dreiseidler T, Scheer M, Keeve E, Zöller JE. The

influence of body mass index, age, implants,

and dental restorations on image quality

of cone beam computed tomography. Oral

Surg Oral Med Oral Pathol Oral Radiol Endod.

2009;108:e108-16.

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14. Besimo CE, Lambrecht JT, Guindy JS. Accuracy of

implant treatment planning utilizing template-

guided reformatted computed tomography.

Dentomaxillofac Radiol. 2000;29:46-51.

15. Roe P, Kan JY, Rungcharassaeng K, Caruso JM,

Zimmerman G, Mesquida J. Horizontal and

vertical dimensional changes of peri-implant

facial bone following immediate placement

and provisionalization of maxillary anterior

single implants: a 1-year cone beam computed

tomography study. Int J Oral Maxillofac

Implants. 2012;27:393-400.

16. Maes F, Collignon A, Vandermeulen D, Marchal

G, Suetens P. Multimodality image registration

by maximization of mutual information. IEEE

Trans Med Imaging. 1997;16:187-98.

17. Fourie Z, Damstra J, Schepers RH, Gerrits PO,

Ren Y. Segmentation process significantly

influences the accuracy of 3D surface

models derived from cone beam computed

tomography. Eur J Radiol. 2012;81:e524-30.

18. Shrout PE, Fleiss JL. Intraclass correlations:

uses in assessing rater reliability. Psychol Bull.

1979;86:420-8.

19. Parsa A, Ibrahim N, Hassan B, Syriopoulos K,

van der Stelt P. Assessment of metal artefact

reduction around dental titanium implants

in cone beam CT. Dentomaxillofac Radiol.

2014;43:20140019.

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113

6Buccal bone measurements at dental

implants the aesthetic region:

a 1 year follow-up cone -beam

computed tomography study.

This chapter is an edited version of the manuscript: KW Slagter, GM Raghoebar, NA Bakker, A Vissink, HJA Meij er.

Buccal bone measurements at dental implants the aesthetic zone: a 1 year follow-up cone beam computed tomography study. Submitted.

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Abstract

Background: Sufficient buccal bone thickness (BBT) is important for optimal aesthetic results of implant

treatment in the aesthetic zone. BBT measurements can be done with cone beam computed

tomography (CBCT), but studies are scarce.

Aim:To assess the mean amount of BBT as a function of time after implant placement and relate

it to immediate and delayed placed implants in the aesthetic zone with a 1 year follow-up

using CBCT-scans.

Materials and Methods: After 1 month and 1 year of definitive crown placement, BBT was measured on CBCTs of

80 patients, part of 2 randomized clinical trials. Patients were divided in 4 study groups

according bony defect (<5 or ≥5 mm) and timing of implant placement (immediate or

delayed). Area of interest was the upper 5mm section of the implant, beginning at the neck

of the implant towards the apical direction and measured in steps of 1 mm along the axis of

the implant).

Results:BBT 1 year after placement of the definitive crown, varied for the immediate placed

implants of study group 1 from 1.52(sd:0.89) to 2.04(sd:0.77) mm (i.e., at the level of the

upper 5 mm of the implant); for study group 2 from 1.08(sd:0.55) to 1.44(sd:0.72) mm and

for study group 3 from 1.00(sd:0.47) to 1.29(sd:0.72) mm. BBT varied from 0.71(sd:0.28)

to 0.92(sd:0.57) mm for the delayed placed implants in study group 4. Mean loss of BBT

between 1 month and 1 year was negigible and independent of the size of the buccal bone

defect (<5 or ≥5 mm) prior to implant insertion and timing of implant insertion.

Conclusion:BBT at dental implants in the aesthetic zone measured on CBCTs, appears to be stable

for immediate and delayed placed implants after placement of the definitive crown,

independent of the size of buccal bone defect prior to implant insertion and timing of

provisionalization.

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Introduction

Single-tooth immediate implant placement in the aesthetic zone is a highly reliable treatment option

for replacing a failing tooth.1-3 Particularly in the aesthetic zone, establishment and maintenance of

healthy peri-implant hard and soft tissues is crucial.4,5 The presence of sufficient bone volume is the most

important prerequisite to achieve primary stability in case of immediate implant placement in an extraction

socket. Peri-implant bone preservation could be considered as one of the key factors in aesthetic

outcome.6 The morphological assessment of bone volume is of great interest to clinicians. In the literature

there is insufficient evidence to set a threshold for minimum buccal bone thickness to ensure the aesthetic

outcome and the long-term stability.6-8 In the aesthetic zone there is data of buccal bone dimensions at

different apical positions when the tooth is still in situ.9 Mean buccal bone thickness (BBT) varied from

0.6 mm to 0.8 mm, measured at different locations at central incisors and lateral incisors.9 The lack of

clinical data regarding bone thickness at buccal aspect of dental implants is probably related to frequently

encountered difficulties in standardization of the measurements. Cone-beam computed tomography

(CBCT) has proven to be a useful tool that has been successfully employed for various dental procedures.10

The choice of an accurate and reliable imaging modality is clinically important in terms of postoperative

monitoring of bone volume stability and to choose an adequate treatment approach.9 The CBCT might be

used for evaluation of implant buccal bone dimension.11-13 The use of 3D image diagnostic and treatment

planning software programs in combination with software programs for tracking and registration of the

exact position of existing dental implants in radiographs can be of help. In view of the aforementioned,

there is need for more studies which measure BBT at single tooth implants in the aesthetic zone on CBCT-

scans. To the best of our knowledge, no clinical trials yet assessed the amount of implant buccal bone

with a reproducible measure method on CBCT-scans at different apical positions along the implant axis.

It is therefore not known how reliable the CBCT-scan is to assess BBT as a function of time after implant

placement in the aesthetic zone.

The aim of the present study was to assess the mean buccal bone thickness (BBT) as a function of time and

relate it to immediate and delayed placed implants in the aesthetic zone in after 1 month and 1 year follow-

up using CBCT-scans.

Material and methods

To measure BBT on a CBCT-scan were 80 patients included with an immediate or delayed placed implant in

the aesthetic region (region 13 to 23) of the maxilla (Figure 1). Patients were part of two randomized clinical

trials. Both trials14,15 were approved by the local Medical Ethic Board (METC 2010.246) and registered in

a trial register (www.isrtcn.com: ISRCTN57251089) as well as that written informed consent was obtained

from all patients. Patients were divided according the bony defect after removal of the failing tooth before

implant placement. Due to sample size calculation, the two trials consisted each out of 20 patients per

study group, with a total of 4 study groups (3 study groups with immediate implant placement and 1 study

group with delayed implant placement).

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Figure 1. Cohort flow diagram.

Enrollment Assessed for eligibility (n=80)

Excluded (n=0) • Not meeting inclusion criteria (n=0) • Declined to participate (n=0) • Other reasons (n=0)

Allocated to intervention (n=40) • Received allocated intervention (n=40) • Did not receive allocated interven tion (give reasons) (n=0)

Lost to follow-up (give reasons) (n=1, patient did not show up at appointments) Discontinued intervention (give reasons) (n=0)

Analysed (n=39) • Excluded form analysis (give reasons) (n=0)

Allocated to intervention (n=40) • Received allocated intervention (n=40) • Did not receive allocated interven tion (give reasons) (n=0)

Lost to follow-up (give reasons) (n=0) Discontinued intervention (give reasons) (n=0)

Analysed (n=40) • Excluded form analysis (give reasons) (n=0)

Randomized (n=80)

Allocation

Follow-Up

Analysis

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A research-nurse not involved in the study blindly allocated by a computerized random number the

patients in:

Study A with patients with a buccal bony defect of <5 mm:

- Group 1 (n=20) : immediate placed implant (NobelActive, Nobel Biocare AB, Goteborg, Sweden) and

immediate provisionalization;

- Group 2 (n=20): immediate placed implant (NobelActive) and delayed provisionalization.

Study B with patients bony defect of ≥5 mm:

- Group 3 (n=20): immediate placed implant (NobelActive) and delayed provisionalization;

- Group 4 (n=20): delayed placed implant (NobelActive) and delayed provisionalization.

For the present study to measure changes in the BBT at the level of implants as a function of time, CBCT

scans were made after one month and 1 year after placement of the definitive crown (iCAT 3D exam

scanner,KaVo Dental GmbH, Biberach, Germany). This scanner was validated for measuring bone thickness

by Fourie et al.16 The method error of this scanner is very small, i.e. 0.05 mm (95 CI 0.03-0.07). The standard

used voxel size was 0.30 and FoV was 100 x100 mm on the CBCT scans. Bone measurements at implants

on the CBCT-scans were done using 3D image diagnostic and treatment planning software (Nobelclinician,

version 2.1 (Nobel Biocare - Guided Surgery Center, Mechelen, Belgium). To allow for reproducible

measurements, a CBCT imaging and software protocol was developed and validated.17

Measuring procedure

Acquired CBCT Digital Imaging and Communications in Medicine (DICOM) datasets were transferred to a

computer. The CBCT images were exported in DICOM multi-file format and imported into a medical image

computing program, Maxilim, version 2.3 (Medicim, Sint-Niklass, Belgium). With Multimodality Image

Registration using Information Theory (MIRIT), which has an accuracy of a subvoxel, the exact position of

the implant could be recognized, determined and implemented in the patients DICOM files.18 The implant

and patient dataset were exactly aligned by the MIRIT method, so that the distance from the central axis

of the implant to the outer contour of the buccal bone could be measured. Area of interest was the upper

5 mm section of the implant, beginning at the neck of the implant towards the apical direction. Exact

dimensions along the implant axis of each implant configuration used in the study was provided by the

manufacturer. Buccal bone measurements (in mm) were performed calculating the distance to the buccal

bone outline minus the radius of the interior contour of the implant. These buccal bone measurements

were done for 5 mm at each millimeter along the axis beginning at the neck of the implant (M0) towards

apical (M1,M2,M3,M4,M5) (Figure 2). Measurements were done (with time interval to prevent recollection)

by two independent operators (HM and KS) in a random order. This after validation of the measurement

procedure17 and an interobserver intraclass correlation coefficient of 0.96 (95%CI 0.93-0.98) and an

intra-observer intraclass correlation coefficient of 0.93 (95%CI 0.88-0.96) for examiner one and an intra-

observer intraclass correlation coefficient of 0.96 (95%CI 0.93-0.97) for examiner two.

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Figure 2a. Measurements were performed at each millimeter along the axis of the implant for 5 mm,

beginning at the neck of the implant.

Figure 2b. Actual measurements beginning at the neck of the implant of the axis of the implant for 5

mm towards apical.

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Statistical analysis

Friedman’s test was used to compare between bone thickness measurements at diff erent levels. In

case of uncertainty of the signifi cance because of the relatively small number of patients analysed and

the large number of outcomes, Bonferroni correction was considered in case of a p-value 0.01<>0.05. A

p-value of 0.05 was considered to indicate statistical signifi cance. All analyses were performed using

SPSS (PASW Statistics 20.0, SPSS Inc.; IBM Corporation, Chicago, IL, USA).

Results

One patient from study group 2 did not show up at appointments and was therefore excluded from

the study, which lead to evaluation of CBCT’s of 79 patients. Baseline charasteristics and treatment

specifi cations are presented in Table 1. The mean and standard deviation values of buccal bone thickness

(BBT) at diff erent levels 1 year after defi nitive crown placement are presented per study and study group

in Table 2.

In study A, with bony defects of <5 mm, the BBT in mm varied at the diff erent apical positions between

1.58(0.55)- 2.12(0.78) in group 1 (immediate placement and immediate provisonalization) and 1.10(0.70)-

1.46(0.82) in group 2 (immediate placement and delayed provisonalization) after 1 month with a

signifi cant diff erence at M1,M2,M3 and M4 (1-4mm apical). After 1 year the BBT in mm varied between

1.52(0.89)- 2.04(0.77) in group 1 and 1.08(0.55)- 1.44(0.72) in group 2 with a signifi cant diff erence at

M1,M2 and M3.

In study B, with bony defects of ≥5 mm, the BBT in mm varied at the diff erent apical positions between

1.11(0.65)-1.29(0.60) in group 3 (immediate placement and delayed provisonalization) and 0.79(0.46)-

0.93 (0.59) in group 4 (immediate placement and delayed provisonalization) after 1 month with a

signifi cant diff erence at M1. After 1 year the BBT in mm varied between 1.00(0.47) – 1.29 (0.72) in group 3

and 0.71(0.28) – 0.92 (0.57) in group 4 with a signifi cant diff erence at M0 (neck) and M1.

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Table 1. Baseline characteristics and treatment specifications per study group.

Variable

Immediate

Group 1 (n=20)

Immediate

Group 2 (n=20)

Immediate

Group 3 (n=20)

Delayed

Group 4 (n=20)

Age Mean ± SD Range

39.4±16.9 19-70

42.3±14.2 23-66

43.7 ±13.9 18-63

48.6 ±16.4 20-72

Gender Male Female

5 15

8 12

11 9

7 13

Implant location

Incisor 1 Incisor 2 Canine

7 8 5

13 6 1

12 5 3

14 6 0

Table 2. Buccal bone measurements and changes after 1 month and 1 year.

Group 1 (n=20)

Group 2 (n=19)

Level of sign.

Group 3 (n=20)

Group 4 (n=20)

Level of sign.

Measurements 1 month

Mean (sd) in mm

Mean (sd) in mm

Mean (sd) in mm

Mean (sd) in mm

M0 (at neck) 1.84 (0.91) 1.27 (0.82) 0.06 1.01 (0.55) 0.79 (0.46) 0.19

M1 2.05 (0.80) 1.39 (0.94) 0.03* 1.29 (0.60) 0.88 (0.57) 0.03*

M2 2.12 (0.78) 1.46 (0.82) 0.02* 1.19 (0.61) 0.93 (0.59) 0.18

M3 2.08 (0.63) 1.39 (0.76) 0.01* 1.26 (0.61) 0.92 (0.62) 0.08

M4 1.89 (0.54) 1.31 (0.75) 0.01* 1.25 (0.67) 0.85 (0.66) 0.06

M5 1.58 (0.55) 1.10 (0.70) 0.07 1.11 (0.65) 0.82 (0.71) 0.18

Measurements 1 year

M0 (at neck) 1.52 (0.89) 1.28 (0.85) 0.41 1.00 (0.47) 0.71 (0.28) 0.07

M1 1.94 (0.79) 1.37 (0.78) 0.04* 1.25 (0.53) 0.81 (0.46) 0.01*

M2 2.04 (0.74) 1.44 (0.72) 0.02* 1.28 (0.67) 0.92 (0.57) 0.08

M3 1.91 (0.64) 1.39 (0.63) 0.02* 1.29 (0.72) 0.90 (0.55) 0.06

M4 1.66 (0.71) 1.24 (0.58) 0.07 1.24 (0.70) 0.85 (0.58) 0.06

M5 1.57 (0.90) 1.08 (0.55) 0.43 1.14 (0.66) 0.77 (0.59) 0.06

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Discussion

A successful aesthetic outcome is suggested to be dependent on establishment of an optimal 3D implant

position within the available bone dimensions and the maintenance of adequate buccal bone over the

buccal implant surface19,20 but the amount of buccal bone is not known. The position of the implant in

relation to the bucco-oral dimension of the alveolar ridge is thought to influence the degree of bone

remodeling following implant placement.21 When there is no buccal bone present due to a bony defect

after extraction, the position and depth of the placed implant could be different compared to an intact

extraction socket or healed site. In the study of El Nahass and Naiem (2015) a mean buccal bone thickness,

in relation to natural incisors still in situ, of 0.57 mm and 0.84 mm was found in the first 4 mm towards

apically. This means that due to the surgical procedure with the slightly palatal placement of the implant

and augmentation of the buccal space in the extraction socket between implant and buccal wall, more

thickness of buccal bone is present at dental implants compared to natural teeth.

The reason behind the 6 measurements (M0-M5) performed after 1 month and 1 year after placement

of the definitive crown is to investigate the buccal bone thickness at different apical positions, clinically

relevant with dental implants in the aesthetic zone. No measurements for BBT at different positions along a

dental implant are known in the literature. Although measured in a different study design, a mean value of

0.16 (0.21) mm BBT is found in an immediate implant group of Raes et al.22 and 2.12 (0.92) mm BBT found

by Degidi et al.23 These numbers are in line for the immediate placed implants in this study. For delayed

placed implants, only a mean amount of 0.20 (0.22)mm is described by Raes et al.22 This number is lower

then the mean amount of BBT in this study.

Loss of buccal bone is inevitable, mainly as a consequence of the disappearance of bundle bone. Therefore

information on the original buccal bone contour prior to removal of the tooth should be provided to

measure the amount of change before and after implant placement. On post-operative CBCTs it is not

known how much of the original contour has been changed after dental implant treatment. It would be

interesting to include preoperative dimensions on CBCT-scans in relation to the actual position of the

placed implant on a post-operative CBCT’scan. More insight would be gained on alterations in BBT due

to the surgical procedure and occurring during the follow-up period. Consequently, implant positioning

in relation to the bucco-oral dimensions of the alveolar ridge, which is thought to influence the degree of

bone remodeling, could then be evaluated.6

Limitations of the study

Some limitations have to be addressed. The interpretation of the buccal bone adjacent to dental implants

on the resolution of the CBCT is insufficient in comparison with light microscopy.11 In the case of very thin

buccal bone, CBCT images seem not always reliable due to background scattering and problems with

standardization of the measurements.22,24,25 The quality and accuracy of a three-dimensional (3D) model

derived from a CBCT is dependent on scanner related factors such as type of scanner, field of view (FoV),

artifacts and voxel size.12 In addition, patient related factors such as patient position and metal artifacts26,

and operator related factors as the segmentation process or interpretation of the CBCT are of influence.27

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Conclusion

Buccal Bone Thickness at dental implants in the aesthetic zone measured on CBCTs, appears to be stable

for immediate and delayed placed implants after placement of the definitive crown, independent of the

size of buccal bone defect prior to implant insertion and timing of provisionalization.

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References

1. Esposito M, Grusovin MG, Polyzos IP, Felice P,

Worthington HV. Timing of implant placement

after tooth extraction: immediate, immediate-

delayed or delayed implants? A Cochrane

systematic review. Eur J Oral Implantol 2010

Autumn;3(3):189-205.

2. Lang NP, Pun L, Lau KY, Li KY, Wong MC. A

systematic review on survival and success

rates of implants placed immediately into fresh

extraction sockets after at least 1 year. Clin Oral

Implants Res 2012 Feb;23 Suppl 5:39-66.

3. Slagter KW, den Hartog L, Bakker NA, Vissink

A, Meijer HJ, Raghoebar GM. Immediate

placement of dental implants in the esthetic

zone: a systematic review and pooled analysis.

J Periodontol 2014 Jul;85(7):e241-50.

4. den Hartog L, Slater JJ, Vissink A, Meijer

HJ, Raghoebar GM. Treatment outcome of

immediate, early and conventional single-tooth

implants in the aesthetic zone: a systematic

review to survival, bone level, soft-tissue,

aesthetics and patient satisfaction. J Clin

Periodontol 2008 Dec;35(12):1073-1086.

5. Cosyn J, Hooghe N, De Bruyn H. A systematic

review on the frequency of advanced recession

following single immediate implant treatment. J

Clin Periodontol 2012 Jun;39(6):582-589.

6. Merheb J, Quirynen M, Teughels W. Critical

buccal bone dimensions along implants.

Periodontol 2000 2014 Oct;66(1):97-105.

7. Klinge B, Flemmig TF, Working Group 3. Tissue

augmentation and esthetics (Working Group

3). Clin Oral Implants Res 2009 Sep;20 Suppl

4:166-170.

8. Teughels W, Merheb J, Quirynen M. Critical

horizontal dimensions of interproximal and

buccal bone around implants for optimal

aesthetic outcomes: a systematic review. Clin

Oral Implants Res 2009 Sep;20 Suppl 4:134-

145.

9. El Nahass H, Naiem SN. Analysis of the

dimensions of the labial bone wall in the

anterior maxilla: a cone-beam computed

tomography study. Clin Oral Implants Res 2015

Apr;26(4):e57-61.

10. Sennerby L, Andersson P, Pagliani L, Giani

C, Moretti G, Molinari M, et al. Evaluation of

a Novel Cone Beam Computed Tomography

Scanner for Bone Density Examinations

in Preoperative 3D Reconstructions and

Correlation with Primary Implant Stability. Clin

Implant Dent Relat Res 2015 Oct;17(5):844-53.

11. Razavi T, Palmer RM, Davies J, Wilson R, Palmer

PJ. Accuracy of measuring the cortical bone

thickness adjacent to dental implants using

cone beam computed tomography. Clin Oral

Implants Res 2010 Jul;21(7):718-725.

12. Kamburoglu K, Murat S, Kilic C, Yuksel S,

Avsever H, Farman A, et al. Accuracy of

CBCT images in the assessment of buccal

marginal alveolar peri-implant defects:

effect of field of view. Dentomaxillofac Radiol

2014;43(4):20130332.

13. Ritter L, Elger MC, Rothamel D, Fienitz T,

Zinser M, Schwarz F, et al. Accuracy of peri-

implant bone evaluation using cone beam CT,

digital intra-oral radiographs and histology.

Dentomaxillofac Radiol 2014;43(6):20130088.

14. Slagter KW, Meijer HJ, Bakker NA, Vissink

A, Raghoebar GM. Feasibility of immediate

placement of single-tooth implants in the

aesthetic zone: a 1-year randomized controlled

trial. J Clin Periodontol 2015 Jun 26. doi:

10.1111/jcpe.12429. [Epub ahead of print]

15. Slagter KW, Meijer HJ, Bakker NA, Vissink

A, Raghoebar GM. Immediate placement of

single-tooth implants in the esthetic zone: a

1-year randomized controlled trial. J Periodontol

2016;15:1-15.

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16. Fourie Z, Damstra J, Schepers RH, Gerrits PO, Ren

Y. Segmentation process significantly influences

the accuracy of 3D surface models derived from

cone beam computed tomography. Eur J Radiol

2012 Apr;81(4):e524-30.

17. Kirsten W Slagter, Gerry M Raghoebar,

Arjan Vissink, Henny J A Meijer. Inter- and

intraobserver reproducibility of buccal bone

measurements at dental implants with cone

beam computed tomography in the esthetic

region. International Journal of Implant Dentistry

2015, 1:8.

18. Maes F, Collignon A, Vandermeulen D, Marchal

G, Suetens P. Multimodality image registration

by maximization of mutual information. IEEE

Trans Med Imaging 1997 Apr;16(2):187-198.

19. Buser D, Martin W, Belser UC. Optimizing

esthetics for implant restorations in the anterior

maxilla: anatomic and surgical considerations.

Int J Oral Maxillofac Implants 2004;19

Suppl:43-61.

20. Grunder U, Gracis S, Capelli M. Influence of the

3-D bone-to-implant relationship on esthetics.

Int J Periodontics Restorative Dent 2005

Apr;25(2):113-119.

21. Qahash M, Susin C, Polimeni G, Hall J, Wikesjo

UM. Bone healing dynamics at buccal peri-

implant sites. Clin Oral Implants Res 2008

Feb;19(2):166-172.

22. Raes F, Renckens L, Aps J, Cosyn J, De Bruyn

H. Reliability of circumferential bone level

assessment around single implants in healed

ridges and extraction sockets using cone

beam CT. Clin Implant Dent Relat Res 2013

Oct;15(5):661-672.

23. Degidi M, Daprile G, Nardi D, Piattelli A. Buccal

bone plate in immediately placed and restored

implant with Bio-Oss((R)) collagen graft: a 1-year

follow-up study. Clin Oral Implants Res 2013

Nov;24(11):1201-1205.

24. Naitoh M, Nabeshima H, Hayashi H, Nakayama

T, Kurita K, Ariji E. Postoperative assessment

of incisor dental implants using cone-beam

computed tomography. J Oral Implantol

2010;36(5):377-384.

25. Roe P, Kan JY, Rungcharassaeng K, Caruso JM,

Zimmerman G, Mesquida J. Horizontal and

vertical dimensional changes of peri-implant

facial bone following immediate placement

and provisionalization of maxillary anterior

single implants: a 1-year cone beam computed

tomography study. Int J Oral Maxillofac Implants

2012 Mar-Apr;27(2):393-400.

26. Ritter L, Mischkowski RA, Neugebauer J,

Dreiseidler T, Scheer M, Keeve E, et al. The

influence of body mass index, age, implants,

and dental restorations on image quality of

cone beam computed tomography. Oral Surg

Oral Med Oral Pathol Oral Radiol Endod 2009

Sep;108(3):e108-16.

27. Besimo CE, Lambrecht JT, Guindy JS. Accuracy of

implant treatment planning utilizing template-

guided reformatted computed tomography.

Dentomaxillofac Radiol 2000 Jan;29(1):46-51.

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7General discussion

&

Conclusions

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General Discussion and Conclusions

The PhD research described in this thesis was performed to provide evidence for the use of immediately

placed dental implants and/or provisionalization in the aesthetic zone. At the start of this PhD project in

2009, studies with immediate implant placement were scarce. Based on the studies performed in this

PhD study one could say in general that the 1-year results of immediately placed dental implants and/or

provisionalization in the aesthetic zone are comparable and very promising.

Current knowledge

A Cochrane review on replacement of a single tooth with an immediate, early or delayed implant in a

fresh extraction socket after tooth extraction evaluated success, complications, aesthetics and patient

satisfaction among immediate, early and delayed implants and whether and when augmentation

procedures are necessary and which is the most effective augmentation technique.1 The authors

concluded that there was insufficient evidence to determine the possible advantages and disadvantages

of immediate, early (immediate-delayed) and delayed implants. However, the authors mentioned

that immediate and early (immediate-delayed) implants may be at a higher risk of implant failure and

complications than delayed implants, while the aesthetic outcome might be better when placing implants

just after tooth extraction. Moreover, there is yet insufficient evidence whether placement of implants in

fresh extraction sockets have to be combined with augmentation procedure as well as which augmentation

techniques is superior when indicated.

A systematic review was performed specifically assessing the clinical outcome of immediate placed

implants in the aesthetic zone.2 This review (Chapter 2) learned that timing of provisionalization was not

associated with outcome in terms of implant survival, which allows for immediate provisionalization after

immediate implant placement. Regarding risk factors for change in marginal bone level (MBL), immediate

provisionalization was associated with less bone loss, which is, to our opinion, a clinically relevant

observation. Furthermore, the use of a flap and connective tissue graft was significantly associated with

more bone loss. Unfortunately, the few included randomized clinical studies were based on short-term

results (1 year), and studies with a longer follow-up period are needed to predict the aesthetic outcome on

the long term. In future, we will report on the long-term results of our randomized clinical trials.

In future trials, not only interproximal bone level dimensions should be taken into account, but also buccal

bone level and buccal bone thickness. Loss of buccal bone after removal of a tooth is inevitable but there

is insufficient evidence to set a threshold for minimum buccal bone thickness needed buccally of the

implant to ensure the aesthetic outcome and the long-term stability.3-5 For example, most studies do not

investigate the size of the bony defect after extraction. However, it has been hypothesized that an intact

labial bony plate of the failing tooth might minimize facial gingival recession.6 Recently, due to altering

techniques, the literature also reports a favourable treatment outcome of immediate implant placement in

extraction sockets with buccal plate dehiscences.7-9 Thus, probably an intact buccal plate is not essential

for immediate implant placement if the implant can be placed with sufficient primary stability. The current

lack of clinical data regarding bone thickness at the buccal aspect of dental implants is probably related

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to frequently encountered difficulties in how to reliably measure buccal bone thickness. A method was

introduced to reliably measure buccal bone thickness after implant placement (Chapter 5), but still no

reliable method is available to measure buccal bone thickness before implant placement.

Besides clinical and radiographic outcomes of the peri-implant tissues, aesthetic evaluation and patient-

centered outcomes are gaining interest in the literature.10-12 The combination of unfavourable bony

defects after extraction and thin overlying soft tissues are a considerable aesthetic risk for maintaining

an acceptable long-term aesthetic outcome for immediately placed implants despite ideal placement and

synchronous hard or soft tissue grafting procedures.6 The aesthetic result is mainly determined by the

shape of these pink soft peri-implant tissues and the contour and colour of the definitive crown.

Immediate placement and provisionalization in the aesthetic zone has some important advantages for

the patient: the patient immediately benefits from this treatment method which can substantially have

a positive impact on the patient’s quality of life. Thus, patient satisfaction scales have to be applied,

in addition to the already used treatment outcome parameters and aesthetic indexes in future studies

assessing the treatment outcome of immediate placement of dental implants in the aesthetic zone (see

Chapters 3 and 4). An aesthetic evaluation by professionals and a patient-centered outcome on quality of

life should be a requirement for publications on single tooth replacement in the aesthetic zone.

Clinical outcome

Survival

In both clinical trials (Chapters 3 and 4) the survival rate of the immediate placed implants was 100%.

Survival rate was defined as the percentage of functional implants one year after definitive crown

placement. This is consistent with the one-year survival rates of around 98% in the literature.1,13 In a

systematic review13, factors were analyzed: reasons for extraction, antibiotic use, position of implant

(anterior vs. posterior, maxilla vs. mandible) and type of loading. Only the regimen of antibiotic use

reduced the survival rate significantly because provision of antibiotics may have helped to prevent post-

operative infection.

Peri-implant hard tissue dimensions

The presence of sufficient bone volume is the most important prerequisite to achieve primary stability in

case of immediate implant placement in an extraction socket. The size of the bony defect after extraction is

considered a considerable aesthetic risk for immediately placed implants despite ideal placement.14 Thus,

peri-implant bone preservation is thought to be a key factor determining the outcome of peri-implant hard

tissues as Marginal Bone level (MBL) and the amount of Buccal Bone Thickness (BBT).4

In two clinical studies (Chapter 3 and 4) the outcome of single-tooth implants in the aesthetic zone were

assessed. Patients were divided according to buccal bony defects of <5 mm and ≥5 mm. Unfortunately,

in the literature, yet no publications are available indicating the effect of the size of the bony defects

on treatment outcome. Although, not supported by evidence, recent studies report that buccal plate

dehiscences possibly not influence the outcome of immediate implant placement.7-9 To achieve primary

stability in case of immediate implant placement in an extraction socket is leading regarding a favourable

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outcome, but it is not an easy procedure. Due to the complexity of the surgery (bone augmentation and soft

tissue grafting in the same operation) the studies in this thesis focused only on the treatment outcome of

immediate placement.

Marginal Bone level

Marginal Bone Level (MBL) change was the primary outcome measure for both clinical studies. MBL led to

comparable outcomes in all patient groups subject to evaluation of immediate and delayed placement and

independent of the size of buccal bone defect prior to implant insertion and timing of provisionalization.

The change in MBL in this study is considerably less than the generally accepted magnitude of up to 1

mm for the first year after immediate implant placement described in the literature.2,13 MBL loss usually

predominantly occurs during the first year after immediate implant placement and hardly progresses

thereafter.13 Changes in MBL will probably not progress after this first year, but a longer follow-up period is

needed.

Change in Buccal Bone level

A successful aesthetic outcome is suggested to be dependent on establishment of an optimal three-

dimensional implant position within the available bone dimensions and the maintenance of adequate

Buccal Bone Thickness (BBT) along the implant axis.15,16 If there is no buccal bone present due to a bony

defect after extraction, the position and depth of the placed implant could be different compared to

an intact extraction socket or healed site. In the present clinical studies, BBT at dental implants in the

aesthetic zone, measured on CBCTs, appeared to be stable after 1 year, irrespective whether immediate

or delayed implant placement used, and independent of size of defect, timing of implant insertion and

provizionalisation. Still the interpretation of BBT adjacent to dental implants on the resolution of the

CBCT is insufficient in comparison with light microscopy.17 In the case of very thin buccal bone, CBCT

images seem not always reliable due to background scattering and problems with standardization of

the measurements.18-20 The quality and accuracy of a three-dimensional (3D) model derived from a CBCT

is dependent on scanner related factors such as type of scanner, field of view (FoV), artifacts and voxel

size.21,22 In addition, patient related factors such as patient position and metal artifacts23, and operator

related factors as the segmentation process or interpretation of the CBCT are of influence.24 Although

precise BBT measurements on CBCT scans rely on various factors, standardized measurements should be

an integral part of the treatment evaluation as the amount of BBT influences the treatment outcome.

Peri-implant soft tissues dimensions

It has been described that immediate implant placement is associated with an increased risk for recession

of peri-implant tissues.25,26 A midfacial recession of 1 mm is reported for the outcome of immediate implant

placement.25,26 Larger bony defects are accompanied by a higher frequency and magnitude of facial gingival

recession (>1.5 mm) 1-year after immediate tooth replacement.6 Recession of the peri-implant tissues in

our clinical studies were clinically acceptable after one year. Due to support of a provisional crown, peri-

implant tissues have the possibility to establish their form around an anatomically shaped crown. In the

aesthetic zone it is therefore a must to use a provisional crown before placement of the definitive crown.

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All other parameters as the health of the keratinized gingiva remained stable throughout the study period,

while the plaque and bleeding indexes remained low in all groups. Participating patients seem to be well

aware of the necessity of an adequate oral hygiene to keep healthy peri-implant tissues on the long term.

Good oral hygiene instructions by the treatment provider are therefore a must.

The health, shape and form of the soft peri-implant tissues mainly determine the aesthetic result. It is

therefore interesting that primary outcome measures in studies are particularly survival or the hard peri-

implant tissues (MBL). The reason could be because the hard tissue dimensions support to a large extent

the soft tissues. A shift towards outcome measures in soft peri-implant tissues is thought to be more

logical in the aesthetic zone.

Aesthetic assessments

The clinical studies (Chapter 3 and 4) specifically asses the differences in the aesthetic zone. Interestingly,

aesthetic scores did not differ between groups with regard to buccal bony defects of <5 mm or ≥5 mm. This

is an important observation as differences in treatment outcome could have been expected. The aesthetic

result is mainly determined by the shape of healthy pink soft peri-implant tissues and the contour and

colour of the definitive crown. The total aesthetic outcome in these clinical studies was mainly influenced

by the appearance of the implant crown (WES) and to a lesser extent by the peri-implant mucosa (PES).27

The PES/WES28 and ICAI29 scores were comparable to results published in the literature regarding

immediately, early and delayed placed single tooth implants in the aesthetic zone.30-32

Patient-centered outcome

There is an increasing focus on patient-centered outcome measures within the field of implant dentistry.33

Immediate placement and provisionalization are known to be associated with high subjective satisfaction

rates.12,34 The Visual Analogue Scales (VAS)35 and the Oral Health Impact Profile (OHIP)36 scores are in line

with the patients’ satisfaction in our clinical studies. Regarding the OHIP-14, no differences were observed

between both studies of all four groups during the entire follow-up, again in line with other studies

regarding immediate implant placement.10,11 It seems that the advantage of immediate placement offering

a shorter treatment time due to the lower number of surgical procedures by combining extraction, implant

placement, and bone grafting in one operative procedure37 is experienced through the eyes of patients as a

contribution to quality of life.

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Future perspectives

In the clinicial studies in this thesis patients were divided according to buccal bony defects of <5 mm or ≥5

mm. In the literature there is no division in the size or shape of bony defects.7,9,38 It is difficult to measure

the exact dimensions of a bony defect when the failing tooth is still in situ. The diverse various osseous

defects in the remaining alveolus after extraction can therefore pre-operatively not be predicted. It would

be interesting to include the pre-operative peri-implant bone dimensions of the CBCT scan in relation to

the actual position of the implant post-operatively. When information is available on the pre-operative BBT

prior to removal of the failing tooth, it could be measured how much of this contour has been changed after

dental implant treatment and what the influence is of the exact size and shape of the bony defect on the

treatment outcome of immediate implant placement in the aesthetic zone.

In the literature there is insufficient evidence to set a threshold for minimum BBT to ensure the aesthetic

outcome and the long-term stability.4,5 If standardized measurements are an integral part of the treatment

evaluation, insight would be gained on alterations in BBT due to the surgical procedure and the

remodeling process in the follow-up period. Not only BBT should be investigated with these standardized

measurements, also interproximal and palatinal peri-implant bone dimensions as well as changes in BBT

in the period between implant placement and provisionalization as this period was not assessed in the

current study.

In the systematic review2 timing of provisionalization was not associated with outcome in terms of

implant survival or changes in peri-implant hard and soft tissues. In the clinical study of buccal bony

defects of <5 mm immediate provisionalization was non-inferior to delayed provisionalization. In buccal

bony defects of ≥5 mm the results of immediate implant placement were very promising. In larger bony

defects in the aesthetic zone it would be therefore interesting to investigate if immediate implant

placement with immediate provisionalization is non-inferior to immediate implant placement with delayed

provisionalization.

The phenomenon biotype is gaining interest.39 A thick or thin biotype could be of influence on the final

aesthetic result. In the literature is described that biotype could be altered to gain more favourable

results.40,41 Possibly the thickness of the mucosa can positively influence the stability of the peri-implant

soft tissues. If pre- and post-operatively biotype is measured, possible alterations in the thickness of the

mucosa can be investigated. In future studies, the effect of biotype on treatment outcome in the aesthetic

zone should be an integral part of the treatment design.

Immediate single implant placement in the aesthetic zone shows good short-term results. The question

remains how the performance is on the long term. Further research in prospective studies on immediate

placed implants is warranted with a longer follow-up period than one year, preferably a follow-up of at

least five years. If these studies, which are expected to be available in the next five years, show that

immediate implant placement is stable on the long term, immediate implant placement should become the

first treatment option if there is a failing single tooth in the aesthetic zone. If the tooth is already missing,

the benefit of one operation combining implant placement and bone grafting in one operative procedure

should be the first treatment option.

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Conclusions

Immediate placement and/or provisionalization of dental implants in the aesthetic zone results in an

excellent short-term treatment outcome in terms of survival, clinical outcome, aesthetic indexes and

patient-centered outcome. Prerequisite is, however, primary stability of the implant.

Specific conclusions are:

- immediate implant placement with immediate provisionalization is non-inferior to immediate

placement with delayed provisionalization in case of labial bony defects <5 mm;

- immediate implant placement with delayed provisionalization is non-inferior to delayed placement

with delayed provisionalization in case of labial bony defects ≥5 mm;

- buccal bone at dental implants in the aesthetic zone, measured on CBCTs, is stable in thickness

during the first year, irrespective of immediate or delayed placement as well as independent

of the size of buccal bone defect prior to implant insertion and timing of implant insertion and

provisionalization.

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PJ. Accuracy of measuring the cortical bone

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Weber HP, Buser D. Outcome evaluation of

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29. Meijer HJ, Stellingsma K, Meijndert L,

Raghoebar GM. A new index for rating

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31. Santing HJ, Raghoebar GM, Vissink A, den

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32. den Hartog L, Raghoebar GM, Slater JJ,

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33. McGrath C, Lam O, Lang N. An evidence-based

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37. De Rouck T, Collys K, Cosyn J. Single-tooth

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38. da Rosa JC, Rosa AC, da Rosa DM, Zardo CM.

Immediate Dentoalveolar Restoration of

compromised sockets: a novel technique. Eur J

Esthet Dent 2013;8(3):432-443.

39. Kan JY, Rungcharassaeng K, Lozada JL,

Zimmerman G. Facial gingival tissue

stability following immediate placement and

provisionalization of maxillary anterior single

implants: a 2- to 8-year follow-up. Int J Oral

Maxillofac Implants 2011;26(1):179-187.

40. Lee A, Fu JH, Wang HL. Soft tissue biotype

affects implant success. Implant Dent

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Notes

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8Summary

&

Samenvatting

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Summary

In the aesthetic zone, the tendency to place single-tooth dental implants immediately after extraction

of a failing tooth, preferably combined with immediate provisionalization, is growing. This tendency is

probably related to evolving society factors, with more demanding patients and a wish for direct result.

Chapter 1 describes the background of immediate dental implant placement in a fresh extraction socket in

the aesthetic zone and the shift towards the peri-implant hard and soft tissues instead of implant survival

as outcome measure. The general aim of the research described in this thesis was to assess the treatment

outcome of immediate dental implant placement in the aesthetic zone. The treatment outcome included

outcome measures as changes in the hard and soft tissue peri-implant tissues, implant survival, aesthetic

evaluation and patient reported outcome with a 1-year follow-up.

A systematic review was performed to systematically assess the clinical outcome of immediately placed

implants in the aesthetic zone (Chapter 2) after one year. Based on 43 studies reporting on immediate

placement of single tooth implants in the aesthetic zone, a pooled analysis was done. Survival of

immediately placed implants was excellent, being 97% after at least one year follow-up. A mean Marginal

Bone Level (MBL) of 0.81±0.48 mm loss was reported for the peri-implant hard tissues. For the peri-implant

soft tissues, a loss of Interproximal Mucosa Level (IML) 0.38±0.23 mm and a loss of Midfacial Mucosa Level

(MML) of 0.54±0.39 mm were reported. Overall, immediate placement with immediate provisionalization of

dental implants in the aesthetic zone results in excellent short-term treatment outcome in terms of implant

survival and minimal change of peri-implant hard and soft tissue dimensions.

A randomized clinical trial is described in Chapter 3 assessing the outcome of single-tooth implants in the

aesthetic zone in bony defects of <5 mm. In this study 40 patients with a failing tooth in the aesthetic zone

were randomly assigned for immediate placement with immediate provisionalization (n=20) or immediate

implant placement with delayed provisionalization (n=20). Follow-up was at 1 month and after 1 year after

placement of the definitive crown. The primary outcome measure was MBL change. Apart from MBL, survival,

soft tissue peri-implant parameters, aesthetic indexes and patient satisfaction were assessed. A MBL change

after one year of 0.75±0.69 mm mesially and 0.68±0.65 mm distally for the immediate group and 0.70±0.64

mm and 0.68±0.64 mm for the delayed group were found. Both study groups had a 100% survival rate.

Recession of the peri-implant tissues for the immediate group were clinically acceptable after one year (IML

of 1.00±0.58 mm and MML 0.95±0.62 mm). This randomized clinical trial showed that immediate placement

and immediate provisionalization was non-inferior regarding MBL to immediate placement with delayed

provisionalization. In addition no clinically relevant differences in other outcomes were observed.

In Chapter 4 a randomized clinical trial is described assessing the outcome of single-tooth implants in the

aesthetic zone in bony defects of ≥5 mm. In this study 40 patients with a failing tooth in the aesthetic zone

were randomly assigned for immediate implant placement with delayed provisionalization (n=20) or delayed

implant placement with delayed provisionalization (n=20). Follow-up was at 1 month and after 1 year after

placement of the definitive crown. The primary outcome measure was MBL change. Other

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outcome measures were survival, soft tissue peri-implant parameters, aesthetic indexes and patient

satisfaction. One year after definitive crown placement, MBL level loss was 0.49±0.46 mm mesially and

0.49±0.46 mm distally mm for the immediate group and 0.45±0.41 mm and 0.68±0.64 mm for the delayed

group. Recession of the peri-implant tissues was clinically acceptable after one year in both groups (IML

0.15±0.16 versus 0.21±0.27 mm and MML 0.15±0.16 versus 0.34±0.55 mm). This randomized clinical trial

showed that immediate placement with delayed provisionalization was non-inferior to delayed placement with

delayed provisionalization in labial bony defects of ≥5 mm. In addition, no clinically relevant differences in

other outcomes were observed.

The aim of the study described in Chapter 5 was to develop a method for reliable, reproducible buccal bone

thickness (BBT) measurements on cone beam computed tomography (CBCT)-scans. A novelty is that this

program, regularly used pre-operatively, was employed to measure the BBT (in mm), after implant surgery.

Inter- and intra-observer reproducibility was assessed by repeated measurements by two examiners on 10

CBCTs at 6 positions along the implant axis. Mean BBT measured by observers one and two was 2.42±0.50 mm

and 2.41±0.47 mm, respectively. Interobserver intraclass correlation coefficient was 0.96 (95%CI 0.93-0.98)

and an intraobserver intraclass correlation coefficient of 0.93 (95%CI 0.88-0.96) for observer one and an

intraobserver intraclass correlation coefficient of 0.96 (95%CI 0.93-0.97) for observer two, respectively. From

this study it can be concluded that CBCTs are suitable for reliable and reproducible measurements of buccal

bone thickness at implants. 1 year after definitive crown placement, BBT at dental implants in the aesthetic

zone measured on CBCT’s appears to be stable for immediate and delayed placed implants in the aesthetic

zone, independent of the size of buccal bone defect prior to implant insertion and timing of provisionalization.

The purpose of the study described in Chapter 6 was to assess BBT using CBCTs and relate it to immediate

and delayed placed implants in the aesthetic zone after 1 month and 1 year follow-up after definitive crown

placement. BBT was measured with the approach described in chapter 5 on CBCTs of 80 patients divided in

4 study groups according to the bony defect (<5 or ≥5 mm) and timing of implant placement (immediate or

delayed). For the purpose of this study, the area of interest in the aesthetic zone was the upper 5 mm section

buccal of the implant, beginning at the neck of the implant towards the apical direction and measured in

steps of 1mm along the axis of the implant. BBT 1 year after placement of the definitive crown, varied for the

immediate placed implants of study group 1 from 1.52±0.89 to 2.04±0.77 mm (i.e., at the level of the upper 5

mm of the implant); for study group 2 from 1.08±0.55 to 1.44±±0.72 mm and for study group 3 from 1.00±0.47

to 1.29±0.72mm. BBT varied from 0.71±0.28 to 0.92±0.57 mm for the delayed placed implants in study group

4. BBT at dental implants in the aesthetic zone measured on CBCTs, appears to be stable for immediate and

delayed placed implants after placement of the definitive crown, independent of the size of buccal bone

defect prior to implant insertion and timing of provisionalization.

Chapter 7 includes the discussion and conclusion of the outcomes of the research performed in this thesis.

The main conclusion is that immediate placement of dental implants in the aesthetic zone results in an

excellent short-term treatment outcome in terms of survival, clinical outcome, aesthetic indexes and patient

satisfaction. There is a need for long-term prospective studies with a follow-up of more >1 year.

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Samenvatting

Bij enkeltandsvervanging in de esthetische zone bestaat de tendens om na extractie van een niet te

behouden tand een implantaat te plaatsen in de extractiealveole, bij voorkeur in combinatie met een

tijdelijke kroon. Deze tendens past bij het huidige tijdsbeeld: veeleisende patiënten met de wens voor een

direct resultaat.

In hoofdstuk 1 wordt kort het hoe en waarom van het direct plaatsen van implantaten in de extractiealveole

in de esthetische zone beschreven. Ook wordt aandacht geschonken aan de verschuiving in de

uitkomstmaat voor het meten van succes van een implantaat, namelijk de verschuiving van het

overlevingspercentage van implantaten als voornaamste uitkomstmaat naar de conditie van de peri-

implantaire harde en zachte weefsels.

Het doel van het in dit proefschrift beschreven onderzoek was het evalueren van het behandelresultaat één

jaar na het direct plaatsen van implantaten in de extractiealveole van een enkel element in de esthetische

zone (enkeltandsvervanging). Als uitkomstmaten werden veranderingen in de harde en zachte weefsel

peri-implantaire weefsels, het overlevingspercentage van de implantaten, een objectieve beoordeling van

het esthetische resultaat en de beoordeling door de patiënt zelf gebruikt.

In hoofdstuk 2 wordt de uitkomst van een systematische literatuurstudie naar de klinische uitkomst van

direct geplaatste implantaten in de esthetische zone beschreven. Gebaseerd op 43 aan de kwaliteitscriteria

voldoende studies, waarin enkeltandsvervanging met direct geplaatste implantaten in de esthetische

zone werd beschreven, werd een gepoolde analyse uitgevoerd. Het overlevingspercentage van de in deze

regio direct geplaatste implantaten was uitstekend: 97% na ten minste één jaar follow-up. Het gemiddelde

verlies aan Marginaal Bot Niveau (MBN) bedroeg van 0,81 ± 0,48 mm, het gemiddelde verlies van het

Interproximale Mucosa Niveau (IMN) bedroeg 0,38 ± 0,23 mm en het gemiddelde verlies van het Midfaciale

Mucosa Niveau (MMN) 0,54 ± 0,39 mm. Op basis van de uitkomsten van de systematische literatuurstudie

werd geconcludeerd, dat het direct plaatsen bij enkeltandsvervanging in combinatie met een directe

tijdelijke kroon in de esthetische zone resulteert in uitstekende kortetermijn resultaten. De resultaten

betreffen zowel de conditie van de peri-implantaire harde en zachte weefsel als het overlevingspercentage

van de implantaten. De beschikbare gegevens waren onvoldoende om een uitspraak te doen over een

objectieve beoordeling van het te bereiken esthetische resultaat en de tevredenheid van de patiënt.

In hoofdstuk 3 wordt een gerandomiseerde klinische studie in de esthetische zone beschreven naar

het behandelresultaat van enkeltandsvervanging bij direct geplaatste implantaten in botdefecten van

<5 mm. In dit onderzoek werden 40 patiënten met een niet te behouden tand in de esthetische zone at

random in 2 groepen ingedeeld. Één groep: het direct plaatsen van een implantaat in de extractiealveole

met daarop direct een tijdelijke kroon (n=20) of één groep: het direct plaatsen van een implantaat in

de extractiealveole met daarop een conventionele tijdelijke voorziening (partiele plaatprothese; n=20).

Een veelheid aan uitkomstmaten werd één maand en één jaar na het plaatsen van de definitieve kroon

gemeten. De primaire uitkomstmaat was verandering in het MBN. Naast MBN, waren de uitkomstmaten het

overlevingspercentage van de implantaten, de conditie van de zachte peri-implantaire weefsels, de

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uitkomst van esthetische indexen en de mate van patiënttevredenheid. Één jaar na het plaatsen van de

definitieve kroon werd een MBN verlies van 0,75 ± 0,69 mm mesiaal en 0,68 ± 0,65 mm distaal van het

implantaat gemeten in de directe tijdelijke kroon groep en een verlies van 0,70 ± 0,64 mm mesiaal en 0,68

± 0,64 mm distaal in de groep die eerst was voorzien van een conventionele tijdelijke voorziening. Geen

enkel implantaat is in beide groepen verloren gegaan. Ook de mate van recessie van de peri-implantaire

weefsels één jaar na het plaatsen van de definitieve kroon bij de directe groep lag op een klinisch

aanvaardbaar niveau (IMN 1,00 ± 0,58 mm, MMN 0,95 ± 0,62 mm). Deze gerandomiseerde klinische

studie toonde aan, dat het direct plaatsen van een implantaat met daarop direct een tijdelijke kroon niet

onderdoet voor de uitkomst van het direct plaatsen van een implantaat met daarop een conventionele

tijdelijke voorziening wat betreft verandering in het MBN. Ook in de andere uitkomstmaten werden geen

klinisch relevante veranderingen gemeten.

In hoofdstuk 4 wordt een gerandomiseerde klinische studie in de esthetische zone beschreven aangaande

het behandelresultaat van solitair direct geplaatste implantaten in alveoles met botdefecten ≥ 5mm. In dit

onderzoek werden 40 patiënten met een niet te behouden tand in de esthetische zone gerandomiseerd

in 2 groepen: Of direct plaatsen van een implantaat in de extractiealveole (n=20) of het conventioneel

plaatsen van het implantaat na een genezingsperiode van 3 maanden (n=20). Wederom werd een

veelheid aan uitkomstmaten één maand en één jaar na het plaatsen van de definitieve kroon bepaald.

De primaire uitkomstmaat was verandering in het MBN. Naast MBN, werden als uitkomstmaten het

overlevingspercentage van de implantaten, de conditie van de zachte peri-implantaire weefsels, de

uitkomst van esthetische indexen en de mate van patiënttevredenheid bepaald. Eén jaar na het plaatsen

van de definitieve kroon bedroeg het MBN verlies 0,49 ± 0,46 mm mesiaal en 0,49 ± 0,46 mm distaal voor

de directe implantaat groep en 0,45 ± 0,41 mm en 0,68 ± 0,64 mm voor de conventionele implantaat groep.

In beide onderzoeksgroepen bleek de mate van recessie van de peri-implantaire weefsels op een klinisch

aanvaardbaar niveau te liggen (IMN 0,15 ± 0,16 versus 0,21 ± 0.27 mm en MMN 0,15 ± 0,16 versus 0,34

± 0.55 mm). In deze gerandomiseerde klinische studie werd aangetoond, dat de uitkomst van het direct

plaatsen van een implantaat in een extractie alveole niet onderdoet voor het conventioneel plaatsen van

het implantaat in geval van een labiaal botdefect ≥5 mm. Ook in de andere uitkomstmaten werden geen

klinisch relevante verschillen gemeten.

Het doel van de in hoofdstuk 5 beschreven studie was het ontwikkelen van een methode om betrouwbaar

en reproduceerbaar de buccale botdikte (BBD) te kunnen meten met behulp van zogenaamde

cone beam computed tomography (CBCT). Aangetoond werd dat middels het daartoe ontwikkelde

computerprogramma inderdaad de BBD (in mm) ter plaatse van het implantaat kan worden gemeten. De

inter- en intra-observator reproduceerbaarheid werd bepaald op basis van herhaalde metingen door twee

onderzoekers, namelijk op 6 posities buccaal langs de implantaat as op 10 CBCTs. De gemiddelde BBD

gemeten door onderzoekers één en twee bedroeg, respectievelijk, 2,42 ± 0,50 mm en 2,41 ± 0,47 mm. De

interobserver intraclass correlatiecoëfficiënt bedroeg 0,96 (95% BI 0,93-0,98). De intra-observer intraclass

correlatiecoëfficiënt bedroeg 0,93 (95% BI 0,88-0,96) voor onderzoeker één en 0,96 (95% BI 0,93-0,97)

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voor onderzoeker twee. Uit deze studie werd geconcludeerd dat CBCTs geschikt zijn voor het betrouwbaar

en reproduceerbaar meten van de BBD ter plaatse van implantaten.

Het doel van de in hoofdstuk 6 beschreven studie was: om de buccale botdikte (BBD) te meten met behulp

van CBCTs en de BBD te relateren aan direct en conventioneel geplaatste implantaten in de esthetische

zone tijdens één maand en één jaar follow-up. BBD werd gemeten op CBCTs met het in hoofstuk 5

beschreven en geteste softwareprogramma bij 80 patiënten verdeeld in 4 studiegroepen na leiding

van het botdefect na extractie(<5 or ≥5 mm) en het tijdstip van plaatsen (direct of conventioneel). Het

aandachtsgebied in de esthetische zone was de eerste 5 mm labiaal van het implantaat, te beginnen bij de

hals van het implantaat en werd gemeten met een interval van 1 mm parallel aan de as van het implantaat.

BBD (in mm) variëerde voor direct geplaatse implantaten van studiegroep 1 van 1.52±:0.89 tot 2.04±0.74

mm ter plaatse van de bovenste 5 mm van het implantaat; voor studiegroep 2 van 1.08±0.58 tot 1.44±0.72

mm en voor studiegroep 3 van 1.00±:0.47 tot 1.29±:0.72 mm. De BBD variëerde van 0.71±0.28 tot 0.92±0.57

mm voor de conventioneel geplaatste implantaten in studiegroep 4. BBD bij enkeltandsvervanging in

de esthetische zone is stabiel voor direct en conventioneel geplaatste implantaten en onafhankelijk van

de grootte van het buccale botdefect vóórafgaand aan het implanteren en het tijdstip van de tijdelijke

voorziening.

De overkoepelende discussie en conclussies uit dit promotieonderzoek worden beschreven in hoofdstuk

7. De belangrijkste conclusie is, dat bij enkeltandsvervanging in de esthetische zone het direct plaatsen

van tandheelkundige implantaten in een extractiealveole resulteert in uitstekende kortetermijn resultaten

(1-jaars resultaten). Wat betreft het overlevingspercentage van de implantaten, de conditie van de peri-

implantaire zachte en harde weefsels, de uitkomst van de esthetische indexen en de tevredenheid van

de patiënt. Of deze techniek ook op de lange termijn leidt tot goede uitkomsten, moet nog nader worden

onderzocht.

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9Dankwoord

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Dankwoord

De inhoud van dit proefschrift is naast ondersteuning van vele cappuccino’s, jazz en klassieke muziek

vooral tot stand gekomen door de hulp van vele verschillende personen. De tijd is gekomen voor het

schrijven van het dankwoord. Al typend heb ik geen idee waar en met wie ik moet beginnen. Het is slechts

een weergave van mijn idee over ieders rol in dit proefschrift. Martin Bril omschreef het treffend: “Geen

idee is ook een idee. Geen idee is het durven volgen van een enkel woord, een paar noten, een plotselinge

penseelstreek; geen idee is vertrouwen, en angst. Wat er in je zit, weet je pas als het er uit is.” Dat dit

proefschrift er nu uit is, had alleen gekund door ideeën, suggesties, interesse en tijd van een ieder die mijn

pad gekruist heeft de afgelopen jaren, waarvoor heel veel dank.

Een eerste dank gaat uit naar de patiënten die hebben geparticipeerd in het onderzoek. Dankzij hun tijd en

bereidwilligheid is de inhoud van dit proefschrift geworden tot wat het is.

Prof. dr. G.M. Raghoebar, hooggeleerde eerste promotor, beste Gerry. Naast een bekwaam chirurg, ben

je vooral een fijne begeleider. Jouw toegankelijkheid zorgde ervoor dat de lijnen kort bleven. Praktisch

gerichte oplossingen waren door jou toedoen altijd voor handen. Ik dank je voor de leerzame momenten

ten tijde van de chirurgie, maar vooral voor je begrip en interesse voor mijn activiteiten buiten het

onderzoek. Ik heb het persoonlijke contact als zeer plezierig ervaren. Hartelijk dank hiervoor!

Prof. dr. H.J.A. Meijer, hooggeleerde tweede promotor, beste Henny. Van mijn promotores heb ik met jou de

meeste tijd in auto’s en steden doorgebracht. Door jouw toedoen weet ik nu waar ik in Mechelen moet zijn

voor de juiste culinaire plekken. We zijn er ook samen achter gekomen waar je in Mechelen niet moet zijn

als je na werktijd de nooduitgang neemt en langs het spoor moet lopen om bij het hotel terug te komen.

Had me toch maar over het hek laten klimmen…Hartelijk dank voor je enthousiasme, organisatorische

talent, klinische ervaring en vooral het doen van vele CBCT metingen in dit onderzoek.

Prof. dr. A. Vissink, hooggeleerde derde promotor, beste Arjan. Jouw snelheid van werken en vermogen

om te schakelen zijn haast niet te bevatten. Jouw inzet om altijd het beste uit een manuscript te willen

halen bleef tot aan het allerlaatste toe 100 procent. Ik ben je hier erkentelijk voor, omdat op deze manier

een promovendus ook altijd het beste uit zichzelf leert halen. Vooral dank ik je voor je toegankelijkheid en

plezierige manier van samenwerken.

Prof. dr. M.S. Cune, prof. dr. G.J. Meijer en prof. dr. E.B. Wolvius, hooggeleerde leden van de

beoordelingscommissie. Dank voor uw bereidheid om zitting te nemen in de beoordelingscommissie en

voor de tijd die u hebt genomen om dit manuscript te beoordelen.

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Prof. dr. F.K.L. Spijkervet, geachte professor. Graag dank ik u voor de gelegenheid die u mij heeft

geboden om mijn promotieonderzoek te kunnen afronden op de afdeling Mondziekten-, Kaak- en

Aangezichtschirurgie van het Universitair Medisch Centrum Groningen. De open en prettige sfeer op de

afdeling is een stimulans voor het doen en voltooien van onderzoek.

Prof. dr. L.G.M. de Bont, geachte professor. Mijn dank voor de mogelijkheid die u mij heeft gegeven dit

promotieonderzoek te starten op de afdeling Mondziekten-, Kaak- en Aangezichtschirurgie.

Dr. N.A. Bakker, lieve Klaas. Niet genoeg etentjes om publicaties te vieren kunnen uitdrukken hoe

dankbaar ik je ben voor je steun en kennis, maar vooral voor je vriendschap. De steuntjes in mijn rug die

je hebt gegeven voor dit proefschrift zijn ontelbaar. Ik heb je leren kennen in 2002 tijdens mijn eerste

studieweek in Groningen. Wat hebben we leuke dingen ondernomen al die afgelopen jaren. Op de een

of andere manier maakte je het toch wel vaak spannend en heb ik regelmatig bijzondere situaties met

je meegemaakt. De afgelopen jaren zijn niet eenvoudig voor je geweest. Ik vind het fijn dat je ook deze

momenten met mij hebt willen delen, dit maakt voor mij onze vriendschap nog dierbaarder. Ik wens jou

en je gezin al het geluk van de wereld toe en dank je dat je vandaag mijn paranimf wilt zijn.

Dr. Y.C.M. de Waal, lieve Yvonne. Ook jou ken ik al sinds mijn eerste studieweek in Groningen. Naast een

geweldige collega ben je vooral een hele fijne en lieve vriendin. Ik ben blij dat we naast cappuccino’s,

wetenschappelijk onderzoek en congressen e.d. ook vooral andere dingen delen. Onze vriendschap is

de afgelopen jaren verdiept, door samen vreugdevolle momenten te delen, maar helaas ook verdrietige.

Ik kijk uit naar nieuwe leuke momenten samen met onze gezinnen. Ik vond het een eer jouw paranimf te

mogen zijn. Dank je wel dat jij vandaag mijn paranimf wilt zijn.

Mw. E. Wartena, beste Esther. Als ervaren onderzoeksassistente wist jij als geen ander hoe belangrijk

de logistiek en planning is bij patiënt- gebonden onderzoek. Ik ben je erg dankbaar voor je inzet en

ondersteuning door je snelle en zorgvuldige handelen. Jouw geheugen is fenomenaal. Aan de hand van

jouw patiënt omschrijving wist ik altijd exact wie er op de afspraak zou verschijnen. Daarnaast hartelijk

dank voor de leuke en gezellige samenwerking.

Mw. M.A. Bezema, mw. H.H. Kooistra-Veenkamp, mw. T.A.P. Schens-Mooi, mw I.J. Valkema, beste

Ans, Ria, Tally en Ingrid. Hartelijk dank voor jullie ondersteuning bij het behandelen van de

onderzoekspatiënten en zorgvuldige werk achter de schermen. Dankzij jullie kwamen de patiënten en

materialen ’s ochtends en ’s middags altijd weer op de juiste plaats terecht.

Mw. L.M.E. Kamstra-Dooper, mw. E.J.G. van Luijk-Voshaar, mw. A. van Oploo-Talens, mw. A. Poppinga,

mw. A. Prins-Schutter, mw. Y. Sanders-Niessen, beste Liliane, Emmy, Tiny, Anne, Anja en Yvonne.

Hartelijk dank voor al jullie tijd en het maken van de vele röntgenfoto’s en CBCT’s tijdens jullie drukke

programma. Een aantal van jullie heb ik zelfs tot aan jullie welverdiende pensioen vele verzoeken

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voorgelegd. Dank ook voor jullie interesse in mijn onderzoek en het feit dat jullie het belang van de patiënt

altijd voorop willen stellen.

Dhr. A.K. Wietsma en dhr. A. Beekes, beste Anne en Ashwin. Hartelijk dank voor het meedenken voor

praktische oplossingen omtrent tandtechnische vraagstukken en het vervaardigen van vele boormallen.

Fijn dat jullie ondanks jullie drukke programma altijd tijd voor mij wilden maken.

Dhr W. Van der Ven en dhr M. van der Veen, beste Menno en Wim. Veel dank voor jullie inzet en die van

jullie collega’s van het Gronings Tandtechnisch Laboratorium met betrekking tot het tandtechnische

aspect van dit onderzoek. Er zijn heel wat afdrukken de revue gepasseerd voor (tijdelijke) kronen en

andere benodigdheden. Jullie flexibiliteit en meedenken om een passende oplossing voor de patiënten

te bedenken heeft geleid tot grote tevredenheid van de patiënten. Hartelijk dank voor de goede

samenwerking.

Dhr M.F. de Wit en drs. J. van der Meer, beste Marnix en Joerd. Hartelijk dank voor het meedenken voor

mogelijkheden omtrent de CBCT’s. Joerd nog een extra dank voor alle heerlijke cappu’s!

Mw. N.E. Geurts-Jaeger, mw. L. Kempers, mw. A. de Vries, mw. S. Wiersema, dhr H.B. de Jonge en dhr. R.M.

Rolvink, beste Nienke, Lisa, Angelica, Fieke, Harry en Richard. Bedankt voor jullie secretariële, technische

en facilitaire ondersteuning. Hartelijk dank voor het meedenken en aandragen van oplossingen als deze

nodig waren.

Dr. L. den Hartog, beste Laurens. Mede dankzij jouw hulp, werd mijn eerste publicatie een feit. Ik dank je

voor je hulp en het meedenken omtrent dit onderzoek en voor de gezelligheid tijdens alle congressen.

C. Boven MSc, dr. F. Guljé , drs. C. Jensen, dhr D. Hentenaar, W. Van Nimwegen MSc, drs. C. Pol, dr. E.

Santing, drs. U. Schepke, dr. W. Slot, dr. C. Stellingsma, dr. G. Telleman, E. Zuiderveld MSc, beste Carina,

Felix, Charlotte, Diederik, Wouter, Christiaan, Eric, Ulf, Wim, Cees, Gerdien en Elise. Als implantologie tak

en mede-onderzoekers, dank ik jullie allen hartelijk voor de interesse in mijn onderzoek en de gezelligheid

tijdens de EAO congressen. Diederik, nogmaals dank voor alle esthetische metingen in de patiëntgebonden

onderzoeken!

Alle mede-onderzoekers en AIO’s van de afdeling Mondziekten-, Kaak- en Aangezichtschirurgie en in het

bijzonder Anne, Ferdinand, Joep, Lukas, Michiel, Nico, Petra, Rodney, Sebastiaan en Willem. Hartelijk dank

voor jullie belangstelling en leuke contacten rond diverse koffieautomaten en lunchtafels.

De administratie wil ik nog apart bedanken voor alle (telefonische) gesprekken en schriftelijke

administratie van de vele patiënten. En daarnaast alle niet met name genoemde medewerkers van de

afdeling Mondziekten-, Kaak- en Aangezichtschirurgie. Hartelijk dank voor de plezierige samenwerking.

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Alle collega’s van Tandartspraktijk de Reijenburg te Veldhoven. Dank voor jullie interesse en

belangstelling voor mijn werkzaamheden buiten en op onderzoeksgebied. Ook al reis ik vandaag de dag

minder vaak af naar het zonnige zuiden, het blijft altijd heel erg leuk om met jullie samen te werken.

Alle collega’s van Buijs Tandartsen te Groningen. Dank voor jullie interesse en ondersteuning bij al mijn

verzoeknummers voor diverse tandheelkundige werkzaamheden.

Alle collega’s van Dental Clinics Hardegarijp. Heel veel dank dat ik naast mijn promotieonderzoek, hier

met zoveel plezier kan werken. Elke pauze met jullie is een feest. Pini en alle collega’s, hartelijk dank

voor jullie interesse, begrip en de mogelijkheden die jullie boden om naast mijn werk, mijn onderzoek te

kunnen afronden.

Drs. E.W.J. de Boer, dr. D. Berghuis-Rickert en drs. J.M. Ijzerman-Schuurhuis. Lieve Esther, Daniela en

Marleen. Wat was en is het toch fijn om naast collega’s, ook kamergenoten met jullie te zijn. Naast de up’s

en down’s te delen op onderzoeksgebied, ben ik jullie zo dankbaar voor jullie oprechte interesse en hulp

wanneer nodig. Bovenal geniet ik van de gezellige momenten buiten het onderzoek om. Ik ben blij dat we

de moeite nemen af te spreken voor een update omtrent niet-gerelateerde onderzoeksonderwerpen. Dat

houden we erin!

Lieve Eva, dank je wel dat jij al jaren mijn coach bent en mij attendeert op de mooie wereld om ons heen.

Lieve tandheelkunde vriendinnetjes: Corine, Eefje, Iris, Nicole, Marjan en Marloes. Dankbaar ben ik dat

we naast de ervaringen over ons vak, vooral de ervaringen over andere zaken kunnen delen. Ik ben blij

dat we de tijd nemen om elkaar te blijven zien en op te zoeken, ook al zijn we inmiddels overal na ons

afstuderen door het land verspreid .

Lieve vrienden en vriendinnen: o.a Anouk, Charlotte, Danique, Dirk, Evelien, Jianhua, Maurits, Maria,

Marijke, Melanie en iedereen die weet dat zij tot dit rijtje behoren. Sommige van jullie ken ik al sinds mijn

jeugd, andere wat korter. Sommige van jullie zie ik vaak, andere minder frequent en andere vooral tijdens

de kerstdiners. Toch weet ik dat het bij elk van jullie goed zit en dat als we elkaar zien het leuk en gezellig

is. Daar ben ik jullie zeer dankbaar voor!

Lieve “party-nimfen”: Anne-Marie, Jorien, Mirjam en Wietse. Ik ben dankbaar voor de band die ik met

jullie elk afzonderlijk heb en alles wat ik met jullie deel en al meegemaakt heb. Jullie zijn fantastische

vrienden. Ik hoop op nog zoveel leuke ervaringen en momenten van samen zijn. Dank jullie wel voor al

het begrip en steun tijdens mijn afwezigheid op momenten waar ik verstek liet gaan om het afronden van

mijn proefschrift voor te laten gaan, hoewel ik graag bij jullie had willen zijn. Laten we gauw vele nieuwe

leuke momenten met elkaar gaan delen!

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Lieve Buijs familie. Lieve Aad & Heleen, dank voor het bijspringen de afgelopen jaren voor Mees als zijn

moeder weer eens achter de laptop zat. Maar vooral dank voor jullie interesse en betrokkenheid ten allen

tijde bij ons gezin. Janne & Kaman, Jauke & Minna, jullie zijn de beste schoonbroertjes en zusjes die ik me

kan wensen. Dank voor al jullie gezelligheid tijdens de Buijs bijeenkomsten.

Lieve Cathinka, fijn dat je als mijn peettante altijd zo geïnteresseerd in mij bent en dankbaar ben ik voor de

vele leuke trips die we hebben mogen en zullen ondernemen.

Lieve zusjes, Margit & Annique. Wat ben ik toch blij met jullie. Ik ben trots op dat een ieder van jullie het

pad kiest, dat bij haar past. Zo verschillend als we zijn, zo sterk is ook de band tussen ons! Waar jullie ook

gaan, ik zal er altijd voor jullie zijn en ik weet dat ik ook altijd bij jullie terecht kan.

Lieve mama, nu ik zelf moeder ben, begrijp ik waarom jij altijd zo je uiterste best hebt gedaan voor ons

alledrie. Al die uurtjes (sprookjes) voorlezen heeft ertoe geleid dat het lezen van al die wetenschappelijke

artikelen een stuk sneller ging. Daarnaast voel ik me gezegend dat je me zoveel talen, kennis en cultuur

hebt proberen bij te brengen, waardoor dit heeft geleid to vele verschillende interesses. Ik ben blij dat als

je op Mees past, hem ook zoveel probeert bij te brengen. Ik hoop op meer tijd samen om dit te kunnen

blijven delen.

Lieve papa, naast het plezier voor ons vak, hockey en kunst, delen wij vooral de liefde voor muziek en met

name de jazz. Aan de vele mooie herinneringen van geweldige concerten, springt vooral de road trip naar

Montreux en de bezoeken aan het North Sea Jazz eruit. Daarnaast ook zoveel dank voor het meten van

alle röntgenfoto’s. Je eerste schreden op wetenschappelijk gebied zijn nu in de literatuur vastgelegd. Het is

maar goed dat je zoveel geduld hebt, wat overigens al bleek tijdens de opvoeding van je drie dochters. Ik

ben zo blij dat jij nog steeds fit op het hockeyveld rondloopt en ik jou nu kan komen aanmoedigen in plaats

van andersom. Dankbaar ben ik voor de aanmoedigingen van jou en mama die ik mijn hele leven heb

gehad om te doen en te kiezen wat leuk is en goed voelt.

Lieve Jap, dat ik dit proefschrift heb afgerond, komt mede door jouw onvoorwaardelijke liefde en steun.

Als geen ander weet jij wat het is om een proefschrift te voltooien. Je bent en blijft de rust zelve als mijn

impulsiviteit weer eens met me aan de haal gaat. Toch weet jij altijd de balans in ons gezin te bewaren

en af en toe de juiste koerswijziging door te voeren. Ook al werken we beiden heel hard, ik ben blij dat

we proberen te genieten van wat er op ons pad komt, de vele mooie reizen en de leuke dingen die we

ondernemen, maar vooral van onze kleine Mees. De toekomst is ons allen onbekend, toch verheug ik me

op mijn toekomst met jou en ons gezin. Dank je wel voor je liefde, jouw eerlijkheid en oprechtheid. Ik hou

van je!

Lieve Mees, mama is zo blij en gelukkig met jou. De afgelopen jaren heb ik ontwikkelingen op allerlei

gebieden mogen meemaken, maar jij bent de grootste ontwikkeling en verrijking van mijn leven. Van jouw

komst heb ik misschien wel het meeste geleerd, waarvoor ik je heel erg dankbaar ben. Vanaf nu gaan we

nog meer plezier maken en samen spelen, joepie!

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Curriculum Vitae

Kirsten Slagter was born on July 3th 1983 in Utrecht, the Netherlands. After finishing

secondary school in 2001, she studied History of Art at the University of Connecticut,

Connecticut (USA). In 2002 she started studying Dentistry at the University of Groningen.

During her study, she was part of the board of the dental student faculty association

Archigenes and member of several committees. She did an internship for several months,

in 2007 at the University of the Western Cape, South Africa. In 2007 she graduated with the

distinction cum laude. After her graduation she worked as a volunteer in several countries

for dental health care organisations. Kirsten started in 2009 her PhD research project at

the University of Groningen and combined this with her work as general dental practitioner

in Groningen, Hardegarijp and Veldhoven. She participated in several committees for the

Royal Dutch Society for Dentistry (KNMT) and was a columnist (2007-2012) for the KNMT.

In 2013 she became a registered implantologist and is currently a member of the junior

committee of the Dutch Society of Oral Implantology (NVOI). Kirsten Slagter lives together

with Jappe Buijs and together they have a son Mees (2014).

Kirsten Slagter

Ubbo Emmiusingel 33

9711 BC Groningen

The Netherlands

[email protected]