Scientific Documentation

Scientif

Table

1. I1.1

1.2

1.3

1.4

1.5

2. T3. M

3.1

3.1

3.1

3.1

3.1

3.1

3.2

3.2

3.2

3.3

3.4

4. B4.1

4.2

4.3

4.4

4.5

4.6

4.7

5. R

ic Documen

of Conte

ntroduction

The suc The bra2 Etching3 Monobo4 The me5

Technical D

Materials sc

Adhesio.1 Tens.2 Tens.3 Shea.4 Shea.5 Conc Etching2

2.1 Scan2.2 Mech

Toleran3 User to4

Biocompatib

Introduc Cytotox2 Genoto3 Skin irri4 Sensitiz5 Conclus6 Toxicolo7

References

ntation Mon

nt

.................

ccess of gla

and Monobo

g with hydro

ond Etch &

echanism ...

Data for Mon

cience and p

on to restor

ile strength

ile strength

ar bond stre

ar bond stre

clusion: ......

g effect of M

nning electro

hanical prop

nce to conta

lerance .....

bility ...........

ction ..........

xicity ..........

oxicity .........

itation and s

zation ........

sions: ........

ogical data

.................

nobond Etch

..................

ass ceramic

ond ............

ofluoric acid

Prime .......

..................

nobond Etch

physical inv

rative mater

on various

of various

ngth of vari

ngth on IPS

..................

Monobond E

on microsco

perties (flex

amination ...

..................

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skin damag

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h & Prime

..................

cs ...............

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h & Prime ..

vestigations

rials ............

s substrates

adhesives a

ious adhesi

S e.max CA

..................

Etch & Prime

ope investig

ural strengt

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gation .........

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s on IPS e.m

mers on IPS

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ydrofluoric a

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Page

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max CAD ..

S e.max CA

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e 1 of 22

........... 2

........... 2

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........... 4

........... 5

........... 6

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........... 9

........... 9

........... 9

......... 11AD .... 12......... 13......... 14......... 14......... 14......... 16......... 17......... 18......... 19......... 19......... 19......... 19......... 19......... 20......... 20......... 20......... 21

Scientif

1. Int

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allows ealing of theond to the reength of th

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ceramicsuccessful alnce IPS Eme [1,2,3] Thi

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[4]. With tess and o

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ceramic

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onobond S 1991. It proof glass cer

as launcheddifferent re

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ar Vivadentsubstrates. e bottle. Its

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n. Fluoride sium to formeven in dilualso be obsmis and evinjuries to

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is very toxm insoluble te solutionsserved sincven the deethe underl

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of trimethomber of stu with Vario

nd Plus alls the silanecould be p

s showed tication of aions in the

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ssolute statdeeper tissuxic due to salts. This

s) can causece the fluoreper subcuaying bone

plication of great benef

e 4 of 22

xypropyl udies [1] link II or

ows the e plus a proved in

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its high induces

e painful ride ions utaneous e due to

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Scientif

Mo1.4

Fig. 4: S& Prime

ic Documen

onobond E

SEM photo e. R&D Ivoc

ntation Mon

Etch & Prim

Monoballowsstep. Ia newroughnefficiewith MEtch &streng

of the etch clar Vivaden

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bond Etch s etching anIt contains w polyfluoriness patternt for bond

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IPS e.max aan, FL

s a single tion of the xypropyl mee etching sless pronou

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Page

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onobond Ets faster duuoric acid. Asay is with ts. The healits milder r

efore dispoature.

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ond Etch& P.

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ond Etch &

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tch & Primeue to less Although Ma XTT50 valu

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f Monobond

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nobond Etch

e the pretreapplication

Monobond Eue of 1970.1he user is inere is no rt necessar

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pplied onto

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ains on the

de reacts w

d surface a

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eatment of steps and

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Fast Green

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xypropyl

Scientific Documentation Monobond Etch & Prime Page 7 of 22

Fig. 5: Structure of Ammonium polyfluoride

Ammonium polyfluoride reacts with the silicon in the glass ceramic without release of HF due to the high chemical affinity between silicon and fluoride. By 19F-NMR spectroscopy (see fig. 6) the absence of HF can be confirmed.

After the extraoral application the remaining liquid is thoroughly rinsed off. After drying a thin silane layer in molecular scale remains at the luting surface (see fig. 3), which reacts via the methacrylate group with the luting composite during curing.

Ammoniumpolyfluorid

HF

156.6ppm

165.8ppm

-120 -140 -160 -180 -200 [ppm]

Fig. 6: 19F-NMR spectrum of ammonium polyfluoride and HF (D20/EtOD). R&D Ivoclar Vivadent AG, Schaan, FL

Scientific Documentation Monobond Etch & Prime Page 8 of 22

2. Technical Data for Monobond Etch & Prime

Product Product category

Monobond Etch & Prime Primer for silica glass ceramics

Function

Substance/Component

Weight

Etchant

Ammonium polyfluoride

15 - 25 Silane

Silane methacrylate

Solvent

Alcohol and water 75 - 85

Pigment

Colourant < 1

Characteristics1 Unit Specification Example value

Bond strength2 MPa 20 493

1 Physical properties,

2 Tensile bond strength (24h), light-cured, with dual-curing resin-based dental luting material 3 IPS e.max CAD, Multilink Automix

Scientif

3. Ma

Ad3.1Monobobond bethe casin variou

Bonding(SBS) measurmeasur

Tensile measurbondingrestoratpreviousthen de

Since thdiameteeach ot

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Fig. 7: T

3.1.1 T R

The bonTest spas refer

To cond(IPS e.

ic Documen

aterials s

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g strength and tensi

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he results aer of the spher to a lim

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duct the mmax CAD,

ntation Mon

science a

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al) accordisize is adh

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elow showsals.

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of Monobotched with h

easuremenIVAG), leu

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and phys

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ned using vstrength (pplied paraplied perpe

nts should dless depen

onto a ping to thehesively boble universa

dependent the results [9, 10].

s a typical

sile strength

various subAG, Schaan

ond Etch & hydrofluoric

ts, ceramicucite (IPS E

h & Prime

sical inve

als gent and as ceramic) and

Monobond Et conditions

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demonstratendent on thprepared, fe instructiononded to theal testing m

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d the test pes can only

suring the

mic substraith Monobo

ricated usin), lithium m

Page

strong ando confirm thn extensivel

hear bond ar bond nsile bond

shear bond f the materbstrate blonother bloce tensile str

procedure (y be compa

tensile stre

ates was evond Plus we

ng lithium dmetasilicate

e 9 of 22

durable at this is ly tested

strength strength strength

strength rial. The ck (e.g. ck of a rength is

(e.g. the ared with

ength of

valuated. ere used

disilicate (Celtra,

Scientific Documentation Monobond Etch & Prime Page 10 of 22

Dentsply) and feldspar (Mark II, Vita) and conditioned either with 5% hydrofluoric acid gel (IPS Ceramic Etching Gel) and Monobond Plus according to the manufacturer's instructions or with Monobond Etch & Prime. Subsequently, the specimens were bonded to Multicore Flow cylinders using Variolink Esthetic (see Fig. 7: Test specimen for tensile strength testing. Whilst the reaction time required for hydrofluoric acid etching varied from material to material, Monobond Etch & Prime allowed all the ceramic samples to be conditioned using the same contact time (scrubbing for 20s; leaving to react for 40s).

To determine the aging resistance of the adhesive bond, a number of specimens were artificially aged by subjecting them to thermocycling (10,000 cycles between 5 and 55C). After thermocycling, the tensile bond strength was determined using a universal testing machine (Z010, Zwick-Roell).

Fig. 8: Tensile bond strength on different ceramic materials: Monobond Etch & Prime (MB E&P) versus Monobond Plus (MBP) with hydrofluoric acid etching (HF), both in combination with Variolink Esthetic as the luting composite. The test specimens were examined after 24-h immersion in water or after 10,000 episodes of thermocycling between 5 and 55C (10k TC).

Monobond Etch & Prime was also tested in combination with Multilink Automix on IPS e.max CAD and IPS Empress CAD samples. In this combination, Monobond Etch & Prime also showed tensile bond strength values comparable to the conventional combination of hydrofluoric acid etching plus Monobond Plus.

0

10

20

30

40

50

60

70

e.max CAD Empress CAD Celtra Mark II

Zugh

aftu

ng [M

Pa]

Zughaftung mit Variolink Esthetic

HF/MBP 24h

HF/MBP 10kTC

MB E&P 24h

MB E&P 10kTC

Scientific Documentation Monobond Etch & Prime Page 11 of 22

Fig. 9: Tensile bond strength on different ceramic materials: Monobond Etch & Prime (MBEP) compared with Monobond Plus (MBP) and hydrofluoric acid etching (HF), both in combination with Multilink Automix as the luting composite. The test specimens were examined after 24-h immersion in water or after 10,000 thermocycles between 5 and 55C (10k TC).

Conclusion: Monobond Etch & Prime produces a similarly high aging-resistant adhesive bond on various ceramic materials as Monobond Plus after hydrofluoric acid etching.

3.1.2 Tensile strength of various adhesives and primers on IPS e.max CAD R&D Ivoclar Vivadent AG, Schaan, FL

Some manufacturers claim that their universal adhesives can generate a sufficiently strong bond to both the tooth structure and restorative material and are therefore suitable for being used as a bonding agent on ceramic materials after hydrofluoric acid etching. The bonding strength of various product combinations consisting of adhesive / primer and luting composite was examined in relation to the following products:

Manufacturer Primer / Adhesive Luting composite 3M ESPE HF Scotchbond Universal RelyX Ultimate Kerr HF Optibond XTR Nexus NX-3 BISCO HF Allbond Universal Duolink Ivoclar Vivadent HF Monobond Plus Variolink Esthetic DC

no HF Monobond Etch & Prime Table 2

The following tensile bond strength results were measured on sandblasted titanium or sandblasted & anodized titanium samples after 24 hours and after 10k TC:

0

10

20

30

40

50

60

70

e.max CAD Empress CAD

Tens

ile B

ond

Stre

ngth

[MPa

]Tensile Bond Strength with Multilink Automix

HF/MBP 24h

HF/MBP 10kTC

MBEP 24h

MBEP 10kTC

Scientific Documentation Monobond Etch & Prime Page 12 of 22

Fig. 10: Tensile bond strength of various adhesives and primers on IPS e.max CAD

* RU/SBU, DL/ABU: 1 debonding episode each (included as a value of 0 MPa in the mean value calculation)

** NX3/OBX: 2 debonding episodes each (with each episode being given 0 MPa in the mean value calculation)

Conclusion: The investigation has shown that Monobond Etch & Prime produces an adhesive bond that is similarly strong and reliable as the bond established with Monobond Plus after hydrofluoric acid etching. By contrast, the universal adhesives resulted in a clearly weaker adhesive bond with spontaneous bond rupturing occurring in some samples in the course of thermocycling.

3.1.3 Shear bond strength of various adhesives and primers on IPS e.max CAD R&D Ivoclar Vivadent AG, Schaan, FL

Similar to the tensile bond strength investigation described in Section 3.1.2, the shear bond strength was also evaluated in a comparison with other systems. The following adhesives / primers and luting composites were tested:

Manufacturer Primer / Adhesive Luting composite3M ESPE HF Scotchbond Universal RelyX Ultimate Kerr HF Optibond XTR Nexus NX-3 BISCO HF Allbond Universal Duolink Ivoclar Vivadent HF Monobond Plus Multilink Automix

no HF Monobond Etch & Prime Table 3

0

10

20

30

40

50

60

VariolinkEstethicMonobondPlus

RelyxUltimateScotchbondUniversal

NexusNX3OtpibondXTR

DuolinkAllbondUniversal

VariolinkEstethicMonobondEtch&Prime

Tensile

Bond

Strength

[MPa

]TensileBondStrengthone.maxCAD

initial 10kThermocycles

Scientif

Fig. 11:Monobo

ConclustrengthMonoboadhesivthermoc

3.1.4 S M

The sheby Proftest spedirectly use diffe

Fig. 12:(MBP) o

0

10

20

30

40

50

60

SBS

(24h

) [M

Pa]

0

10

20

30

40

50

ShearB

ondS

tren

gth[

MPa

]

ic Documen

Shear bonond Plus (H

sion: The h investigatond Plus aves - excecycling.

Shear bondM. Irie, Oka

ear bond st. Irie at Okaecimens accompared

erent metho

Shear bonon IPS e.ma

0

0

0

0

0

0

0

MonoEtch&

Multilink

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0

0

0

0

0

0

ntation Mon

d strength oF) and vario

shear bondtion: the hi

and Monoboept for S

d strength ayama Univ

rength of Mayama Univccording to with the sh

ods.

d strength vax CAD.

obond&Primek Automix

M

M

ar Bon

30min

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nobond Etch

on IPS e.maous univers

d strength iighest and ond Etch &cotchbond

on IPS e.mersity, Japa

Monobond Eversity. TheISO TR 1

hear bond s

value of Mo

Monobond Plus

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nd StreSBS

rBondS

h & Prime

ax CAD: cosal adhesive

nvestigationmost relia

& Prime. TUniversal

max CAD an

Etch & Prime bond stre1405: 2003strength va

onobond Etc

s

x

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ngth oS (24h, 37C

1d

Strength

omparison oes

n showed aable bond sThe adhesiv

failed

e on IPS ength values

3 [11, 12]. lues obtain

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nd XTR

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on IPS eC) SBS

h

of Monobond

a similar picstrengths wve bonds o

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(MBEP) an

Bond UniversalDuolink

e.max CS (10kTC)

MBEP

MBP

Page

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cture as thewere achievof all the utand stress

was also exermined on e results car investigati

nd Monobon

l Scotchbond URelyX Ult

CAD

13 of 22

rime,

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Etch & Prime.max CA

ength invesoviding an sives.

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acid has to t, the applic

materials: sc

icroscope AG, Schaan

bond Etch scanning e

flat ceramEmpress CAconditioned ructions forcohol and cscanning ele

erials and ap

Ceramic hing Gel

20 s with water 60s with water 30s with water 60s with water

h & Prime

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cation of Mocrub for 20s

investigatin, FL

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r use and cleaned in ectron micro

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Mono

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processes u

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Page

comparativnt after 30

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14 of 22

vely high minutes

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Scientific Documentation Monobond Etch & Prime Page 15 of 22

Fig. 13: SEM images of glass-ceramic samples after conditioning with hydrofluoric acid or Monobond Etch & Prime Monobond Etch & Prime produced a clear etching pattern on all the ceramic materials investigated; the etching effect, however, was less pronounced than the etching effect of hydrofluoric acid. Although the etching effect of Monobond Etch & Prime is weaker than that of hydrofluoric acid, it is still strong enough to produce sufficient microretention for a reliable adhesive bond, as confirmed by the bond strength measurements (see Section 3.1)

Without conditioning Monobond Etch & Prime (60s)

IPS Ceramic Etching Gel ((reaction time b/w 20 -

60s, depending on material; acc. to IfU)

IPS e.max CAD

IPS Empress CAD

Celtra

Mark II

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Fig. 14:5% hyd The scabecomeprolonga substreaction

3.2.2 M R

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16 of 22

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Fig. 15:Etch & P

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17 of 22

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20

30

40

50

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totoxicity xicity refers T assay is liferation in educes there cytotoxic

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enotoxicityxicity refersmaterial.

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have an etan irritating

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19 of 22

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s: Etch & Primnature of Mo etch glass

of the exth the patienEtch & Pr

ctions, howsis of the non-genoto

shown that nstructions y potential

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nobond Etch

has been cots are not arial's etchingetching effeoric acid, wuse of hydrces.

ntains methnsitization, win patients te material nd avoiding, made of

compounds

me is slightlyMonobond Es-ceramic mtraoral applnt. rime contai

wever, are exinformationoxic.

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Scientific Documentation Monobond Etch & Prime Page 21 of 22

5. References [1] R. Frankenberger, M. Taschner, F. Garcia-Godoy, A. Petschelt, N. Krmer: Leucit-reinforced glass ceramic inlays and onlays after 12 years; J. Adhes. Dent. 10, 393 (2008)

[2] A. A. Galiatsatos, D. Bergou: Six-year clinical evaluation of ceramic inlays and onlays; Quintessence Int. 39, 407 (2008)

[3] P. C. G, C. F. Selz, A. Voulgarakis, S. Stampf, C. F. Stappert: Prospective clinical study of press-ceramic overlap and full veneer restorations: 7-year results; Int. J. Prosthodont. 27,355 (2014)

[4] R. Stenberg, L. Matsson: Clinical evaluation of glass ceramic inlays (Dicor); Acta Odontol. Scand. 51, 91 (1993)

[5] A. Della Bona, J. R. Kelly: The clinical success of all-ceramic restorations; J. Am. Dent. Assoc. 139, 8S (2008)

[6] A. Attia, M. Kern: Long-term resin bonding to zirconia ceramic with a new universal primer; J. Prosthet. Dent. 105, 319 (2011)

[7] X. F. Meng, K. Yoshida, N. Gu: Chemical adhesion rather than mechanical retention enhances resin bond durability of a dental glass-ceramic with leucite crystallites; Biomed. Mater. 5, 044101 (2010)

[8] M. zkan, A. Allahbeickaraghi, M. Dndr: Possible hazardous effects of hydrofluoric acid and recommandations for treatment approach: a review; Clin. Oral. Invest. 16, 15 (2012)

[9] S.D. Heintze, V. Rousson (2011). Pooling of dentin microtensile bond strength data improves clinical correlation. J Adhes Dent 13:107-10.

[10] S.S .Scherrer, P.F. Cesar, M.V. Swain (2010). Direct comparison of the bond strength results of the different test methods: a critical literature review. Dent Mater 26:e78-93.

[11] M. Irie, Y. Maruo, G. Nishigawa, K. Suzuki, D.C. Watts (2010). Physical properties of dual-cured luting-agents correlated to early no interfacial-gap incidence with composite inlay restorations. Dent Mater 26:608-15.

[12] E.C Munksgaard, M. Irie, E. Asmussen (1985). Dentin-polymer bond promoted by Gluma and various resins. J Dent Res 64:1409-11.

[13] L. Xiaoping, R. Dongfeng, N. Silikas; Dent. Mater. 30, e330 (2014)

Scientific Documentation Monobond Etch & Prime Page 22 of 22

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Ivoclar Vivadent AG Research & Development Scientific Services Bendererstrasse 2 FL - 9494 Schaan Liechtenstein Contents: Dr. Thomas Vlkel and Dr. Erik Braziulis Edition: March 2015