PRF+1% MF for Class II Mandibular Furcation Defects

Study Overview
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Brief Summary
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The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

Detailed Description
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Background: For improving efﬁcacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone. Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.

Official Title
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Evaluation of Adjunctive Effect of 1% Metformin To Platelet Rich Fibrin For Mandibular Class II Furcation Defects: A Randomized Controlled Clinical Trial

Conditions
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Furcation Defects

Intervention / Treatment
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* Procedure: Open flap debridement (OFD)
* Procedure: OFD with Platelet rich fibrin (PRF)
* Procedure: OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP); No history of antibiotic or periodontal therapy in the preceding 6 months. Exclusion Criteria: Aggressive periodontitis patients Systemic conditions known to affect the periodontal status; Medications known to affect the outcomes of periodontal therapy; Hematological disorders and insufficient platelet count (<100,000/mm3); Pregnancy/lactation; Smoking and tobacco use in any form Immunocompromised individuals; Those having unacceptable oral hygiene (plaque index [PI] >1.5). Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect | Procedure: Open flap debridement (OFD)<br>* Open flap debridement (OFD) alone<br>|
| Active Comparator: Group 2<br>SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect | Procedure: OFD with Platelet rich fibrin (PRF)<br>* Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement<br>|
| Active Comparator: Group 3<br>SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin for treating furcation defect | Procedure: OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form<br>* Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone fill assessed in percentage | assessed in percentage | baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth measured in mm | measured in mm | baseline to 9 months | 
| Relative vertical attachment level measured in mm | measured in mm | baseline to 9 months | 
| Relative horizontal attachment level measured in mm | measured in mm | baseline to 9 months | 
| modified sulcus bleeding index | 0-3 scale | baseline to 9 months | 
| plaque index | 0-3 scale | baseline to 9 months |