Rajiv Gandhi University of Health Sciences s68

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE –II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME OF THE CANDIDATE DR. SHRIPARNA BISWAS AND ADDRESS POST GRADUATE STUDENT (IN BLOCK LETTERS) DEPARTMENT OF PERIODONTOLOGY RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, MYSORE ROAD, BANGALORE – 560060.

2 NAME OF THE INSTITUTION RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, BANGALORE-560060.

3 COURSE OF STUDY AND MASTER OF DENTAL SURGERY SUBJECT PERIODONTOLOGY

4 DATE OF ADMISSION TO THE 25.05.2012 COLLEGE

5 TITLE OF THE TOPIC: COMPARATIVE EVALUATION OF BIOACTIVE GLASS (BONE GRAFT-PUTTY) AND PLATELET RICH FIBRIN IN THE TREATMENT OF FURCATION DEFECTS. 6 BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY :

Management of molars with furcation involvement has been one of the most

challenging problems in periodontal therapy. Teeth with furcation involvement undergo more

extensive and rapid clinical attachment loss and are lost with greater frequency than are single

rooted teeth.1

Multiple approaches have been used to resolve furcation defect including autografts,

demineralized freeze-dried bone allografts (DFDBAs), bovine-derived xenografts, barrier

membranes and combinations of membranes and bone grafts.2

An alloplast is a biocompatible, inorganic synthetic bone grafting material. At

present, alloplasts marketed for periodontal regeneration fall into two broad classes: ceramics

and polymers. Among the different alloplastic materials used in periodontal therapy,

hydroxyapatite, calcium phosphates and bioactive glass ceramics have the capacity to form a

carbonated hydroxyapatite layer on their surfaces once exposed to simulated body fluids or

implanted in vivo, hence the concept of “bioactivity.” The material is easy to manipulate and

is hemostatic. Bioglass stimulates osteoblasts to produce more bone tissue than other

synthetic biomaterials which lead to the concept of “osteoproduction” and

“osteostimulation.”.3

Platelet rich fibrin (PRF), first described by Choukron et al in France, is a 2nd

generation platelet concentrate for surgical use. PRF is an autologous leukocyte and platelet

rich fibrin biomaterial. Potential clinical indications of PRF include improvement in soft

tissue healing and bone graft protection and remodeling. Unlike other platelet concentrates,

this technique does not require any anticoagulants or bovine thrombin or any other gelling agent. This open protocol is very simple and inexpensive.4

The purpose of the present study is clinical and radiographical evaluation and comparison of the efficacy of bioactive glass bone graft putty material and PRF in the treatment of furcation defects.

6.2 REVIEW OF LITERATURE:  A study was conducted to compare the clinical attachment gain as well as vertical and

horizontal bone fill obtained with open flap debridement (OFD) alone and OFD with

bioactive glass particulate in the treatment of mandibular Class II furcation defects.

Twenty mandibular class II furcation defects were selected in 16 systemically healthy

patients out of which 10 defects were treated with OFD alone (Group I) and other 10

defects were treated with OFD and bioactive glass particulate (Group II). Each defect

was randomly assigned to Group I and Group II. The soft tissue and hard tissue

measurements including vertical probing depth, horizontal probing depth, clinical

attachment level, gingival recession, vertical depth of the furcation defects, and

horizontal depth of the furcation defects were recorded at baseline and six months post

surgery. In conclusion, bioactive glass showed significant improvement in clinical

parameters like vertical and horizontal defect fill in mandibular class II furcation

defects when compared to OFD.1

 In one of the studies which was designed to evaluate the effectiveness of

autologous PRF in the treatment of mandibular degree II furcation defects compared

with open flap debridement (OFD) Using a split-mouth design, 18 patients with 36

mandibular degree II furcation defects were randomly allotted and treated either with

autologous PRF and OFD or OFD. Clinical and radiographic measurements were

recorded at baseline and 9 months postoperatively. All clinical and radiographic

parameters showed statistically significant improvement at the sites treated

with PRF and OFD compared to those with OFD alone.2

 In a study which was conducted to compare the clinical parameters of probing depth and bleeding on probing using a bioactive glass particulate to open flap debridement

alone in human mandibular class II furcations. 15 patients were included in the study

with moderate to advanced adult periodontitis. Each patient received surgical therapy

consisting of regenerative therapy using bioactive glass compared to open flap

debridement in the furcation defects. The results of therapy were statistically

significant in the defects treated with bioactive glass, regarding the clinical parameters

of probing depth reduction and the reduction in bleeding on probing.5

 In this study which was conducted to evaluate the efficacy of a bioactive alloplast,

PerioGlas, in comparison with open flap debridement in intra bony defects. 8

systemically healthy volunteers were chosen, each having 2 collateral sites with ≥6

mm clinical probing depth and radiographic evidence of an intrabony defect.

Randomly, one defect was treated with open flap debridement plus bioactive glass

(test) and the other with open flap debridement alone (control). Measurements were

recorded at baseline, 3, 6, 9 months. Both treatments showed no significant

differences between the two groups at any point of time. However, radiographically,

bioactive glass group showed significant improvement in bone fill over the sites

treated with open flap debridement alone. The alloplastic bone graft material,

PerioGlas, demonstrated clinical advantages beyond that achieved by debridement

alone.6

 A study was designed to evaluate the efficacy of bioactive glass in the management of furcation defect associated with an endo perio lesion. A 22 year old patient with an

endo-perio lesion in the right mandibular first molar was treated. The defect was

initially treated with endodontic therapy. Following the endodontic treatment, the

furcation defect was treated using bioactive glass in a putty form. At the end of 9

months, there was gain in clinical attachment level and reduction in probing depth.

Radiographic evidence showed that there was a significant bone fill.7

 A study was conducted to investigate the clinical and radiological effectiveness of

autologous PRF in the treatment of intra-bony defects of chronic periodontitis

patients. 32 intrabony defects were treated. By using the image analysis software

intra-bony defect fill was calculated on standardized radiographs (from the baseline

and 9 months). For all clinical and radiographic parameters test group was performed

better than control group, and the difference was found to be statistically significant.

Furthermore, image analysis revealed significantly greater bone fill in the test group

compared with control group. There was greater reduction in PD, more CAL gain and

greater intra-bony defect fill at sites treated with PRF than the open flap debridement

alone.8

6.3 AIMS AND OBJECTIVES OF THE STUDY:  To evaluate the clinical and radiographic efficacy of Bioactive glass bone graft putty

material and platelet rich fibrin in the treatment of Grade II furcation defects.

 To compare the clinical and radiographic efficacy of Bioactive glass bone graft putty

material and platelet rich fibrin in the treatment of Grade II furcation defects.

7 MATERIALS AND METHODS :

7.1 SOURCE OF DATA

Patients visiting to the Department of Periodontology, Rajarajeswari Dental College and

Hospital, Bangalore.

7.2 METHOD OF COLLECTION OF DATA :

20 mandibular molar furcation defects will be randomly selected from chronic periodontitis

patients belonging to the age group of 20-50 years and will be grouped as follows:

Group I – 10 furcation defects to be treated using Bioactive glass bone graft putty material.

Group II – 10 furcation defects to be treated using platelet rich fibrin.

INCLUSION CRITERIA :

1. Chronic periodontitis patients.

2. Presence of grade II furcation defects in mandibular molars (Glickman’s

classification).9

3. Systemically healthy patients. EXCLUSION CRITERIA

1. Smokers.

2. Patients on any medication taken within the last 6 months which may alter the

periodontal status.

3. Pregnant and lactating mothers.

4. Patients who have undergone periodontal treatment within a period of 1 year.

SCREENING EXAMINATION INCLUDE

 Gingival index by Loe H & Silness P, 1963.

 Plaque index by Silness P & Loe H, 1964.

 Vertical probing depth to be measured using graduated William’s periodontal probe.

 Horizontal measurement of the furcation defect using a Naber’s probe and using

customized occlusal stents.

 Gingival margin position measured from a fixed reference point to gingival margin

using a customized stent.

 Clinical attachment level measured from CEJ to the base of the pocket.

 Standardized radiographs of the defect sites will be taken using radiovisiograph

(RVG) and IOPAR film grids to measure the amount and density of bone fill.

DURATION OF THE STUDY: 18 Months PROCEDURE:

Each patient will be informed and signature will be taken on a consent form after explaining the nature of the study. All patients will undergo scaling, root planing, oral hygiene instructions, and occlusal adjustment wherever indicated. Prior to surgery, two customized acrylic stents will be fabricated, one for gingival margin position and other for furcation depth. Measurements for clinical parameters will be recorded from the fixed reference point (stent). All measurements will be recorded by a single investigator. The cases will then be reevaluated. Only when the patient demonstrates adequate plaque control, periodontal surgery will be performed. In each pair of furcation defects, one site will be assigned for treatment with autologous platelet rich fibrin and the other one will be treated with Bioactive glass bone graft putty material. The surgical procedure will be performed under local anesthesia. The postoperative evaluation and data collection will be done at 3, 6 and 9 months. The clinical parameters to be recorded are:

Soft tissue parameters (using stent):

 Pocket depth (from gingival margin to base of the pocket)

 Clinical attachment level

Hard tissue parameters:

 Horizontal probing depth of furcation involvement (using stent)

 Radiographic analysis and density measurement of defect site

STATISTICAL ANALYSIS: Following tests of statistics will be used in the present study:

1. Mann-Whitney U test- to compare the result between test site and control site.

2. Wilcoxon sign Rank Sum Test- to compare the results between the various time

intervals.

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

patients or other human or animals? If so, please describe briefly :

The study requires patients to undergo periodontal surgery and radiographic evaluation of

the treated sites pre and post operatively.

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

Ethical clearance letter has been attached.

LIST OF REFERENCES: 8 1. Manoj H, Dilip GN, Ashita SU. A clinical evaluation of bioactive glass particulate in

the treatment of mandibular class II furcation defects. Braz J Oral Sci 2007;6:1450-

2. Sharma A, Pradeep AR. Autologous Platelet-Rich Fibrin in the Treatment of

Mandibular Degree II Furcation Defects: A Randomized Clinical Trial. J Periodontol

2011;82:1396-1403.

3. Dumitrescu AL. Bone Grafts and Bone Graft Substitutes. Verlag Berlin

Heidelberg:Springer 2011;9:73-144.

4. David M, Ehrenfest D, Corso DM, Diss A, Mouhyi J, Charrier JB. Three-Dimensional

Architecture and Cell Composition of a Choukroun’s Platelet-Rich Fibrin Clot and

Membrane. J Periodontol 2010;81:546-555.

5. Anderegg CR, Alexander DC, Freidman M. A Bioactive Glass Particulate in the

Treatment of Molar Furcation Invasions. J Periodontol 1999;70:384-387.

6. Subbaiah R, Thomas B. Efficacy of a bioactive alloplast, in the treatment of human

periodontal osseous defects-a clinical study. Med Oral Patol Oral Cir Bucal 2011;16 :

239-244.

7. Narang S, Narang A, Gupta R. A Sequential Approach in treatment of Perio-endo

Lesion. J Indian Soc Periodontol 2011;15:177-180.

8. Thorat MK, Pradeep AR, Pallavi B. Clinical effect of autologous platelet-rich fibrin in

the treatment of intra-bony defects: a controlled clinical trial. J Clin Periodontol 2011;

38: 925–932.

9. Ammons WF, Harrington GW. Furcation, The Problem and Its Management. In Newman, Takei, Carranza, editors:Carranza's Clinical Periodontology 9th Edition.

Philadelphia: W.B. Saunders Co.2002:825-839. 9. SIGNATURE OF CANDIDATE

10. REMARKS OF THE GUIDE

11. 11.1 NAME AND DESIGNATION DR. SAVITA.S M.D.S OF THE GUIDE PROFESSOR AND HEAD

DEPARTMENT OF PERIODONTOLOGY RAJARAJESWARI DENTAL COLLEGE & HOSPITAL, MYSORE ROAD, BANGALORE- 60. 11.2 SIGNATURE

11.3 CO- GUIDE DR. NALINI.M.S MDS READER DEPARTMENT OF PERIODONTOLOGY RAJARAJESWARI DENTAL COLLEGE & HOSPITAL, MYSORE ROAD, BANGALORE- 60.

11.4 SIGNATURE

11.5 HEAD OF THE DR. SAVITA. S M.D.S DEPARTMENT PROFESSOR AND HEAD DEPARTMENT OF PERIODONTOLOGY RAJARAJESWARI DENTAL COLLEGE & HOSPITAL, MYSORE ROAD, BANGALORE- 60. 11.6 SIGNATURE

12. 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE