Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects

Study Overview
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Brief Summary
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The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.

Detailed Description
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Background: Various regenerative materials have been introduced and tested in the treatment of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and cytokines which are the key factors for regeneration of bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone. Methods: Seventy two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic defect fill was evaluated at baseline and 9 months.

Official Title
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Platelet Rich Fibrin Combined With 1% Alendronate Gel in Treatment of Mandibular Degree 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% Alendronate (Drug) in gel form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of buccal Class 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: Systemic conditions known to affect the periodontal status; Medications known to affect the outcomes of periodontal therapy; Hematological disorders and insufficient platelet count (<200,000/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 Aggressive periodontitis

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: Double


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% Alendronate for treating furcation defect | Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form<br>* Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate 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 | baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth | measured in mm | baseline to 9 months | 
| Relative vertical attachment level | measured in mm | baseline to 9 months | 
| Relative horizontal attachment level | 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 |