Rajiv Gandhi University of Health Sciences s23

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate and GUNTAAS K. SETHI, address POST GRADUATE STUDENT (In block address) DEPARTMENT OF PERIODONTICS, THE OXFORD DENTAL COLLEGE AND HOSPITAL, HOSUR ROAD, BANGALORE-560068

2. Name of the institution THE OXFORD DENTAL COLLEGE & HOSPITAL, BANGALORE.

3. Course of study and subject MASTER OF DENTAL SURGERY, PERIODONTICS

4. Date of admission to course 03-06-2013

5. Title of the Topic A SPLIT MOUTH COMPARATIVE EVALUATION OF BIODEGRADABLE COLLAGEN MEMBRANE WITH AND WITHOUT PLATELET RICH FIBRIN IN THE TREATMENT OF MILLER’S CLASS I OR II GINGIVAL RECESSION DEFECTS

6. Brief resume of the intended work: 6.1 Need for the study:- With the rise in the aesthetic concern and the population experiencing root hypersensitivity, the treatment of localized gingival recession has become one of the most common therapeutic procedures. Various surgical techniques have been reported to obtain root coverage and subepithelial connective tissue graft has been considered as the gold standard of periodontal plastic surgery. Despite that, it has many limitations. Hence, membranes and platelet rich fibrin (PRF) have been introduced into surgical protocols. Collagen membranes have advantages like hemostasis, chemotaxis for the fibroblasts, weak immunogenicity, easy manipulation and its potential of achieving new attachment formation.7 PRF is an autologous leukocyte and platelet rich fibrin biomaterial. It is rich in cytokines and growth factors like TGFβ1, PDGF, VEGF, ILGF.1, 2 This combination is a powerful bioscaffold within an integrated reservoir of growth factors for tissue regeneration. Thus, the aim of the present study is to compare the efficacy of collagen and PRF with collagen alone.

6.2 Review of Literature: A comparative evaluation of modified coronally advanced flap (MCAF) alone or in combination with platelet rich fibrin(PRF) membrane for the treatment of adjacent multiple gingival recession defects was conducted. 20 subjects with adjacent class 1 or 2 recession defects were treated by MCAF on both sites in addition to PRF on the test site.After 6 months, there was no significant difference in the probing depth in the MCAF+ PRF site and the MCAF site but there was a significant difference in gain in clinical attachment level in the control group.3

A split mouth comparative evaluation of a bioabsorbable collagen membrane(GTR) and subepithelial connective tissue graft(SCTG) was done in which 10 subjects were taken. Two groups were made; one was treated by SCTG and the other by GTR. After 6months, the mean root coverage was found to be 84.84% ± 16.81% and 84.0% ± 15.19% in SCTG group and GTR group respectively. The mean keratinized gingival width increase was 1.50% ± 0.70% and 2.30% ± 0.67% in SCTG group and GTR group respectively. It was concluded that resorbable collagen membrane can be a reliable alternative to subepithelial connective tissue graft for root coverage.4

In a study, efficacy of a collagen membrane as a GTR technique and demineralised bone matrix as a space maintainer in the treatment of Miller's Class I gingival recession was evaluated, 17 patients were treated with a combination of a collagen barrier used along with a bone graft and coronally advanced flap technique. Clinical parameters were recorded at baseline, 3, 6 and 9 months. The study showed a highly significant reduction in the recession depth (70.29 ± 21.96%) at 9 months. 5

In a randomised clinical split mouth trial, evaluation of a xenogenic collagen matrix(CM) with coronally advanced flap (CAF)was done in the treatment of gingival recession defects. 45 patients received either CAF+CM or CAF alone. After 6 months, root coverage was 75.29% for test group and 72.66% for controlled group. There was an increase in mean width of keratinized gingiva in the test group (1.97- 2.90 mm) and 2- 2.57mm in the control group. It was concluded that collagen matrix with coronally advanced flap showed enhanced gingival thickness and width of keratinized gingiva when compared to coronally advanced flap alone.6

In a study, comparative evaluation of biodegradable collagen membrane(BCM) and platelet rich fibrin( PRF) with subepithelial connective tissue graft(SCTG) in the treatment of Class 1 and 2 gingival recession defects was done. 15 patients with 30 recession defects were taken and were treated randomly by BCM+PRF or by SCTG. It was concluded that both the approaches were equally effective for the treatment of miller’s class 1 and 2 recession defects.7 6.3 Aims and Objectives of the study: 1. To evaluate the efficacy of collagen membrane on root coverage in Miller’s class 1 or 2 gingival recession. 2. To evaluate the efficacy of collagen membrane with PRF on root coverage in Miller’s class1 or 2 gingival recession. 3. To compare the efficacy of collagen membrane alone and collagen membrane with PRF on root coverage in the treatment of Miller’s class1 or 2 gingival recession. 4. To assess the width of keratinized gingiva.

7 Materials and method: 7.1 Source of the data: The study will be conducted on patients reporting to the Department of Periodontics, The Oxford Dental College and Hospital, Bangalore.

7.2.1 Method of collection of data:

 25 patients with bilateral Miller’s class 1 or 2 gingival recession.

 By the toss of a coin, each side will be treated either by collagen membrane (Group A) or collagen membrane with PRF (group B).

 Patients will be explained about the nature of the study, the need for surgery and the outcome of it, followed by which a verbal & written consent will be obtained.

7.2.2 Inclusion criteria 1. Patients with 18-40 years of age. 2. Bilateral Miller’s class 1 or 2 gingival recession. 3. Patients with ≥1mm of width of keratinized gingiva. 4. Patients with a thick gingival biotype. 5. Non smokers. 6. Systemically healthy subjects. 7. Presence of good oral hygiene maintenance.

7.2.3 Exclusion criteria: 1. Presence of dehiscence or fenestration. 2. Malposed teeth. 3. Root caries. 4. History of any periodontal surgery in same area in the past 6 months. 5. Pregnant or lactating mothers. 6. Patients on medications. STUDY DESIGN:  Patients satisfying the above mentioned criteria will be included in the

study.

Initial therapy- Thorough scaling and root planing will be carried out and oral hygiene instructions will be given.

A stent will be fabricated for standardization of the measurements to be assessed.

 The following clinical parameters will be assessed in millimetres:

1. Gingival recession depth 2. Gingival recession width 3. Probing depth 4. Clinical attachment level 5. Keratinized gingival width

 All the above mentioned parameters will be recorded at the baseline and at 3 and 6 months post-surgically.

Surgical phase  Local anesthesia 2% lignocaine with 1:2,00,000 adrenaline will be administered.  A coronally advanced flap will be raised.  Horizontal incisions will be made in the mesial and distal interdental papilla at the level of CEJ.  Apically divergent vertical incisions will be made extending into the alveolar mucosa.  A sulcular incision will be given that will connect horizontal and vertical incisions.  A full thickness flap will be raised 3-4 mm apical to the crest of the defect, beyond which, a partial thickness flap will be raised.  The exposed root surface will be thoroughly planed.  The facial portion of interdental papillae will be de-epitheliazed for proper placement of the flap.  Group A- collagen membrane will be trimmed and contoured to the size of the defect and will be secured in place with 4-0 resorbable vicryl sutures. The mobilized flap will be advanced coronally, 2-3 mm coronal to the CEJ and secured by non-resorbable 4-0 sutures.  Group B- PRF will be prepared immediately before its placement. 10

ml of blood will be taken by venipuncture from the cubital vein and immediately centrifuged at 3000 rpm for 10 minutes. 2-3 ml of the top layer of platelet poor plasma will be pipetted out. PRF that is obtained will be

placed in a sterile dappen dish. Required amount of platelet rich fibrin will

then be placed over the denuded root surface. Collagen membrane will be trimmed and contoured to the size of the defect and will be placed over the PRF and secured with resorbable 4-0 vicryl sutures. The flap will be advanced coronally, 2-3mm coronal to the CEJ and sutured with non- resorbable 4-0 sutures.  Periodontal dressing will be placed to cover the surgical sites  Patients will be prescribed antibiotics (cap amox 500mg 3 times a day for 5 days), analgesics (tab diclofenac sodium 50mg thrice a day for 1 day) along with, 10 ml of 0.2% chlorhexidine gluconate mouth rinse twice a day for 2 weeks. In case of any allergy, appropriate antibiotics and analgesics will be prescribed. Patients will be asked to refrain from oral hygiene measures at the treated site for 7 days.

Postsurgical phase All the patients will be recalled after a week for suture removal and after every month for scaling and reinforcement of oral hygiene instructions. The clinical parameters will be measured during the follow up visits at 3 and 6 months.

Study duration: 1 year

Statistical analysis:

Results will be subjected for statistical analysis by following tests.

 Paired T test

 Mann-Whitney U test

 Two-way ANOVA

7.3 Does this study require any investigation or interventions to be Conducted on patients or other human beings? Yes, this study involves surgical regenerative procedures to be carried out on patients and collection of blood sample from patients for preparation of platelet rich fibrin.

7.4 Has ethical clearance been obtained from your institution? - Yes. The ethical clearance certificate has been attached.

8. List of references: 1. Douhan D, Choukran J, Diss A, Douhan S, Anthony J, Douhan J. Platelet rich fibrin: a second generation platelet concentrate. Part 11: platelet related biologic factors. Oral surg Oral med Oral pathol oral radiol Oral endod 2006;101:E45-50 2. Anilkumar A, Geetha A, Pameela E. Platelet rich fibrin: A novel root coverage approach. J Indian Soc Periodontol 2009 Jan-Apr; 13(1): 50-54 3. Aroca S, Keglevich T, Barbeiri B, Gera I, Etienne D. Clinical evaluation of modified coronally advanced flap alone or in combination with a platelet rich fibrin membrane for the treatment of adjacent multiple gingival recession defects: a 6 month study. J periodontol 2009;80:244-252 4. Babu HM, Gujjari SK, Prasad D, Sehgal PK, Srinivasan A. Comparative evaluation of a bioabsorbable collagen membrane and a connective tissue graft in the treatment of localized gingival recession: A clinical study. J Indian Soc Periodontol 2011; 15:353-8 5. S. Nanditha, M.S Priya, S. Sabitha, K.V Arun, T. Avaneendra. Clinical evaluation of the efficacy of a GTR membrane (HEALIGUIDE) and demineralised bone matrix (OSSEOGRAFT) as a space maintainer in the treatment of Miller's Class I gingival recession. J Indian Soc Periodontol. 2011 Apr-Jun; 15(2): 156–160. 6. Jepsen K, Jepsen S, Zuchhelli G, Stefanini M, de Sanctis M, Baldini N et al. Treatment of gingival recession defects with a coronally advanced flap and xenogenic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol 2013;40:82-89 7. Rajan P, Malagi SK, Vempati S., Kumar Cs, Mohan S. Comparative evaluation of biodegradable collagen membrane and platelet rich fibrin with subepithelial connective tissue graft in the treatment of miller’s class 1 and 2 gingival recession defects: a randomized controlled study. Univ Res J Dent 2013;3:7-15

9. Signature of the candidate

10. Remarks of the guide

11. 11.1 Name and designation of the guide DR. SAVITHA A.N

PROFESSOR DEPARTMENT OF PERIODONTICS, THE OXFORD DENTAL COLLEGE AND HOSPITAL. Signature BANGALORE- 560068

11.2 Head of the department DR. ANIRBAN CHATTERJEE

PROFESSOR AND HEAD OF THE DEPARTMENT, DEPARTMENT OF PERIODONTICS, THE OXFORD DENTAL COLLEGE AND HOSPITAL. Signature BANGALORE-560068

Remarks of the Principal

12. Signature