Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects

Study Overview
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Brief Summary
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This study is intended to compare the efficacy of platelet-rich fibrin as a graft and a membrane versus hyaluronic acid(Gengigel) and amniotic membrane in the treatment of mandibular grade II furcation defects.

Detailed Description
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Platelet-rich fibrin is a fraction of plasma that provides a rich source of growth factors and may enhance the stabilization and revascularization of the flaps and grafts. Hyaluronic acid is a naturally occurring non-sulfated high molecular weight glycosaminoglycan that forms a critical component of the extracellular matrix and contributes significantly to tissue hydrodynamics, cell migration and proliferation. Hence its administration to periodontal wound sites could achieve beneficial effects in periodontal tissue regeneration. Amniotic membrane is being used for various regenerative procedures as it is a rich source of various collagen and non-collagen proteins such as laminin, fibronectin and proteoglycan.

Official Title
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Efficacy of Platelet Rich Fibrin as a Graft and Membrane Versus Hyaluronic Acid and Amniotic Membrane in the Treatment of Mandibular Grade II and Grade III Furcation Defects- A Randomized Clinical Trial

Conditions
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Furcation Defects

Intervention / Treatment
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* Procedure: Conventional Flap surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade II furcation involvement Exclusion Criteria: Smokers, Pregnant and lactating women, Systemically compromised patients

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be equally divided into two test groups, Group A and Group B after phase I therapy. The group A patients will be treated with conventional flap surgery and the furcation would be debrided, following which platelet-rich fibrin will be placed as a graft and a membrane. The flap will then be sutured back. The group B patients will also be treated with conventional flap surgery after furcation area is debrided, and hyaluronic acid (gengigel)will be placed as a graft over which amniotic membrane will be placed. The flap would then be sutured.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Group A patients will be treated with conventional flap surgery. The furcation defects will be debrided and autologous platelet-rich fibrin will be paced as a graft and membrane. Later the flap will be sutured. | Procedure: Conventional Flap surgery<br>* After administering local anaesthetic a full thickness flap will be raised and reflected to expose the furcation defects. The furcation defects would then be debrided and the graft and membrane secured in position. Later the flap would be sutured back.<br>|
| Experimental: Interventional Comparator<br>Group B patients will be treated with conventional flap surgery. The furcation defects will be debrided and Hyaluronic acid (Gengigel) will be placed as a graft. Amniotic membrane (Tata Memorial Hospital Mumbai) will be placed over the graft and later the flap will be sutured. | Procedure: Conventional Flap surgery<br>* After administering local anaesthetic a full thickness flap will be raised and reflected to expose the furcation defects. The furcation defects would then be debrided and the graft and membrane secured in position. Later the flap would be sutured back.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological Parameters | Amount of Bone fill in the furcation (Change in Bone level) to be measured by Cone Beam Computed Tomography(CBCT) | Baseline and 9 months post surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Parameter | Change in relative vertical clinical attachment level will be measured by Williams probe in millimeters in the furcation area. | Baseline and 9 months post surgery. | 
| Clinical Parameter | Change in relative horizontal clinical attachment level will be measured in millimeters by the Nabers probe in the furcation area | Baseline and 9 months post surgery |