RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKABANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE

AND ADDRESS

(IN BLOCK LETTERS)

DR. CHANDRASHEKAR RAJU

DEPARTMENT OF ORAL AND MAXILLOFACIAL

SURGERY,M. S. RAMAIAH DENTAL COLLEGE,

BANGALORE-560054

2. NAME OF THE INSTITUTION M. S. RAMAIAH DENTAL COLLEGE

BANGALORE

3. COURSE OF STUDY AND

SUBJECT

MASTER OF DENTAL SURGERY(MDS)

ORAL AND MAXILLOFACIAL SURGERY

4. DATE OF ADMISSION OF

COURSE

27-07-2013

5. TITLE OF THE TOPIC

“EFFICACY OF INWARD FRAGMENTATION TECHNIQUE VERSUS

CONVENTIONAL TECHNIQUE IN THE SURGICAL REMOVAL OF IMPACTED

MANDIBULAR THIRD MOLAR”

6. Brief resume of intended work

6.1 Need for the study:

The extraction of impacted mandibular third molars is one of the most commonly performed

minor procedures in Oral and Maxillofacial surgery. It involves the manipulation of both soft

and hard tissues causing immediate post-operative sequelae. Conventional surgical extraction

of impacted mandibular third molar requires lateral and distal bone removal to allow

mobilization of the tooth. Morbidity following third molar surgery is currently being

discussed with the aim of reducing intraoperative as well as postoperative complications.

Recently a shift in paradigms can be observed towards atraumatic techniques in third molar

surgery. In this regard, a new technique called inward fragmentation technique (IFT) has

evolved in selective cases of third molar impactions which does not involve rising of flap or

bone removal.

Evidence regarding the efficacy of IFT is sparse, therefore this study aims to compare the

outcomes of conventional technique versus IFT in the surgical removal of impacted

mandibular third molars.

6.2 Review of literature:

Third molar extraction remains one of the most ubiquitous procedures performed by oral and

maxillofacial surgeons, and most third molar surgeries are performed without intra or post-

operative difficulties. In all surgical procedures, proper preoperative planning and the

blending of surgical technique with surgical principles is of paramount importance for

decreasing the incidence of complications. They may occur intraoperatively or develop in the

postoperative period. The four most common postoperative complications of third molar

extraction reported in the literature are localized alveolar osteitis (AO), infection, bleeding,

and paresthesia. Surgical removal of third molars is often associated with postoperative

pain, swelling, and trismus 1, 2.

Accessibility is a key issue in removal of impacted teeth. A full-thickness mucoperiosteal

flap must be elevated to allow for visualization and placement of retractors, drilling

equipment, elevators, and forceps. The lower third molar incision most commonly used is an

envelope flap that extends from the mesial of the first molar to the ramus with lateral

divergence of the posterior extension to avoid lingual nerve injury. With this flap an anterior

vertical releasing incision at the distal aspect of the first or second molar is made. In either

flap design the incision must be full thickness. The extent of the flap reflection should be

limited to the external oblique ridge laterally. Reflecting beyond this point leads to increased

dead space and more edema.3

Adoption of bone removal plus tooth section technique minimizes the possibility of exerting

too much pressure when removing wisdom teeth. Merely removing bone and extracting or

elevating a wisdom tooth afterwards causes it to hinge at its apex. Removing bone to the

level of the cement enamel junction of the tooth is useful for access as well as enabling us to

section the tooth into several segments. Having more tooth segments reduces the tooth size

and the possibility of hinging the root over inferior alveolar nerve. This is because the

segments are taken out one by one, leaving the apical portion with plenty of space coronally

for the root segment to be elevated.4

Extraction of an impacted mandibular third molar may result in a temporary or permanent

injury of the IAN. Although the incidence of such a complication is relatively low, its

frequency increases as the roots of the impacted tooth move closer to the IAN. To overcome

the risk of IAN injury, intentional odontectomy has also been proposed.5

The morbidity rates involving different methods frequently used for surgical removal of

impacted third molars are not completely resolved. The use of a surgical method with

minimum postoperative complication is needed.6

Modern Dentistry is based on conservative thinking taking into consideration that the reason

for lateral and distal bone removal for mandibular third molar extraction is to allow an

outward directed mobilization, a modern technique should provide a technical solution which

preservation of the mandibular architecture without the removal of bone necessary for

outward mobilization. This may be achieved by systematic and precise space making

procedure in order to provide stepwise fragmentation and inward mobilization of the tooth.7

6.3 Objectives of the study

To evaluate two different techniques in terms of:

1. Duration of surgery

2. Bone height in relation to operative site

3. Post-operative sequelae

4. Limitations of inward fragmentation technique if any

7. Materials And Methods:

7.1 Source of data

Patients reporting to the Department of Oral and Maxillofacial Surgery, M. S. Ramaiah

Dental College and Hospital requiring bilateral surgical removal of impacted mandibular

third molars.

Sample size: Fixing alpha at 5% and beta at 20% and to have power of the study at 80%,

estimated sample size is 15.

Type of study: A randomized controlled clinical study

Inclusion criteria

Healthy individuals in the age group of 18-35 years with bilaterally impacted

mandibular third molars.

Mandibular third molar completely or partially impacted with the absence of acute

inflammatory symptoms.

Exclusion criteria

Horizontally impacted mandibular third molars

Patients in whom the second molar is missing or is indicated for extraction

Subjects with any underlying systemic disease or compromised immunity

Pregnant women and lactating mother

7.2 Method of collection of data.

After pre-operative evaluation and obtaining written informed consent, all the patients

included in the study will be allocated into two groups as follows:

Group A: Patients undergoing surgical removal of impacted mandibular third molar by

Conventional Technique on one side.

Group B: Patients undergoing removal of the impacted mandibular third molar using

the Inward Fragmentation Technique on the opposite side.

All the patients undergoing surgical procedure will be advised a 5 day course of oral

antibiotic and analgesic. Patients will be advised to take soft diet for 3 days and rinse oral

cavity using chlorhexidine mouth wash for 7 days postoperatively.

Follow up:

Patients will be evaluated for the following parameters:

Preoperative

1.Type of impaction

a. Clinical

b. Radiological

2. Mouth opening

Measurement of inter-incisal distance using a divider and scale.

3. Baseline measurement to assess post operative swelling by measuring distance

between

Point A :- Tragus and soft tissue pogonion

Point B :- Tragus and lateral corner of mouth

Point C :- Lateral corner of the eye and angle of mandible

4. Bone height

In relation to impacted third molar using Panoramic radiograph (OPG).

Intraoperative: Duration of surgery

Post operative: The following parameters are assessed on day 1, day 3 day 7 and

after 1 month.

1. Pain:- using Visual analogue scale

2. Mouth opening: - Measurement of inter-incisal distance using a divider and scale.

3. Swelling:- Measuring distance between

Point A :- Tragus and soft tissue pogonion

Point B :- Tragus and lateral corner of mouth

Point C :- Lateral corner of the eye and angle of mandible

4. Bone height

In relation to operative site using Panoramic radiograph (OPG).

5. Assessment of delayed healing or infection

STATISTICAL TESTS:

Student’s t-test would be employed to compare all the parameters between

experimental and control sides.

Repeated measures ANOVA would be used to assess the change in parameters in

different time intervals.

7.3 Does the study require any investigations or interventions to be conducted on the

patients or other humans or animals? ( If so please describe briefly)

YES.

Investigations:

Intraoral periapical radiograph

Panoramic radiograph (OPG)

Interventions:

All patients will undergo routine oral prophylaxis prior to the surgical procedure

A written informed consent will be taken from the patient prior to surgical

removal of impacted mandibular third molar.

7.4 Has Ethical clearance been obtained from your institution in case of 7.3?

YES

8. List Of References

1. Gary F. Bouloux, Martin B. Steed, Vincent J. Perciaccante, Complications of Third Molar

Surgery, Oral Maxillofacial Surg Clin N Am 19 (2007); 117–128

2. Abel Garcia Garcia, Francisco Gude Sampedro, Jose Gandara Rey, Mercedes Gallas

Torreira: Trismus and pain after removal of impacted lower third molars, J Oral Maxillofac

Surg 55:1223-1226, 1997

3. Sam E. Farish, Gary F. Bouloux, General Technique of Third Molar Removal , J Oral

Maxillofacial Surg Clin N Am 19 (2007) 23–43

4. Ngeow WC; Tooth section technique for wisdom teeth, Int J Oral Maxillofac Surg 38:908,

2009

5. Landi L,Manicone PF,Piccinelli S,Raja A,Raja R:A novel surgical approach to impacted

mandibular third molars to reduce the risk of paresthesia;a case series, J Oral Maxillofac

Surg 68(5):969-974, 2010

6. Praveen G,Rajesh P,Neelakandan RS,Nandagopal CM: Comparison of morbidity following

the removal of mandibular third molar by lingual split,surgical bur and simplified split bone

technique. Indian J Dent Res 2007;18:15-8.

7. Engelke W,et al.,Removal of impacted mandibular third molars using an inward

fragmentation technique(IFT)-Method and first results,journal of cranio-maxillo-facial

surgery(2013) 1-7.

INFORMED CONSENT

TITLE: “EFFICACY OF INWARD FRAGMENTATION TECHNIQUE VERSUS CONVENTIONAL TECHNIQUE IN THE SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR”

UNDERTAKING BY THE INVESTIGATOR:

Your consent to participate in the above study is sought. You have the right to refuse consent or withdraw the same during any part of the study without giving any reason. We undertake to maintain complete confidentiality regarding the identity of the subjects and the information obtained from the subject/patient during the course of the study. We assure that all the standard infection control precautions will be strictly adhered to throughout the study. If you have any doubts regarding the study, please feel free to clarify the same. Even during the study, you are free to contact any of the investigators for clarification if you desire. The list of investigators and their contact numbers are below:

Dr. Chandrashekar raju Dr. K .Ranganath 9448668386 9844181097

CONSENT

I _________________________________the undersigned hereby authorize Dr.___________________________at M. S. Ramaiah Dental College and Hospital to perform upon me the following procedure(s) for research purpose:

1. Surgical removal of impacted mandibular third molar by Conventional Technique on one side and Inward Fragmentation Technique on the opposite side. All the patients undergoing surgical procedure will be advised a 5 day course of oral antibiotic and analgesic. Patients will be advised to take soft diet for 3 days and rinse oral cavity using chlorhexidine mouth wash for 7 days postoperatively.

The above procedure along with the purpose of the study has been explained to me in detail in intelligible terms. I have received appropriate response to all my doubts and clarifications. I understand that I will be exposed to radiation dose twice or more during the course of the study. I also understand that photographs will be taken in the course of the study and that the results generated from this study can be published in scientific literature, for which I do not have any objections. I have understood that I have the right to refuse my consent or withdraw it at any time during the study.I understand that signing this consent form indicates that I voluntarily agree to participate in this study.

I confirm that I understand the information presented in this consent form.

Signature of Participant Date:Place:

Signature of Witness

Date:Place:

Signature of the investigator 1 (Dr. Chandrashekar Raju)

Date:Place:

Signature of the investigator 2 (Dr. K. Ranganath)

Date:Place:

M. S. RAMAIAH DENTAL COLLEGE AND HOSPITAL

IMPACTED TOOTH REMOVAL PROFORMA

Name: O.P.No.: Date:

Age: Sex: Occupation:

Address:

CHIEF COMPLAINT:

HISTORY OF PRESENT ILLNESS:

H/O PERICORONITIS/ABSCESS:

ANY TREATMENT RECEIVED: Y/N

IF YES, PLEASE SPECIFY:

DENTAL HISTORY:

MEDICAL HISTORY:

DRUG ALLERGY:

CLINICAL EXAMINATION:

EXTRAORAL:

Facial symmetry:

Mouth opening(using scale and divider):

Micrognathia:

Macrognathia:

Normal:

INTRAORAL:

Impacted tooth: Surrounding soft tissue:

Inflammed/Normal

Ulcer: Present/Absent

Fibrosed: Y/N

Completely covered by soft tissue or partially exposed:

Pericoronitis:

Acute infection if any:

Swelling:

Discharge:

Pain/ Difficulty in chewing:

No. of episodes:

Condition of adjacent mandibular second molar:

Any caries:

Periodontal involvement:

RCT: Y/N

Upper tooth:

Present/Absent

Impinging on soft tissue: Y/N

Position: Normal/Buccal/Supra erupted

Tongue: Macro/Micro/Normal

INVESTIGATIONS:

IOPAR:

OPG:

Radiographic and Clinical co-relation:

Tooth impaction: Y/N

DIAGNOSIS:

CLASSIFICATION:

WAR LINES:

WHARF ASSESSMENT:

TREATMENT PLAN:

TREATMENT DONE:

Surgical method:

Block given:

Incision:

Procedure:

Duration:

Medication:

Follow up and complications:

TABLE 1: Preoperative parameters

Type of impaction

Interincisal distance

Baseline measurement

Radiographic

assessment of bone

height

TABLE 2: Intraoperative parameters

Duration of Surgery

TABLE 3: Post operative parameters

Parameters Day 1 Day 3 Day 7 1 Month

Pain

Swelling

Inter-incisal distance

Infection

Radiographic assessment of bone height

Additional findings