Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis

Study Overview
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Brief Summary
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The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.

Detailed Description
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Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate, act as reservoirs of growth factors and cytokines which are the key factors for regeneration of the 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 with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients. Methods: Ninety patients with single defects were categorized into three groups: OFD alone, OFD with PRF,OFD with PRF+1% ALN. Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction (IBD) was evaluated at baseline and 9 months.

Official Title
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Efficacy Of Platelet Rich Fibrin With 1% Alendronate For Treatment Of Intrabony Defects In Chronic Periodontitis: A Randomized Controlled Clinical Trial

Conditions
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Chronic Periodontitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Presence of 3-wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an Intra-oral Periapical Radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing[SRP]) in asymptomatic teeth. 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 (<200,000/mm3); Pregnancy/lactation; Smoking and tobacco use in any form Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index27 [PI] >1.5) after reevaluation of Phase I therapy . Teeth with furcation involvement, non-vital teeth, 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: Quadruple


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 periodontal defect | Procedure: Open flap debridement (OFD)<br>* Oral prophylaxis followed by Open flap debridement (OFD)<br>|
| Active Comparator: Group 2<br>SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating periodontal defect | Procedure: OFD with Platelet rich fibrin (PRF)<br>* Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect<br>|
| Active Comparator: Group 3<br>SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating periodontal defect | Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate<br>* Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate placement into the bone defect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| defect depth reduction (%) | assessed in percentage | Change from baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth (mm) | measured in mm | Change from baseline to 9 months | 
| clinical attachment level (mm) | measured in mm | Change from baseline to 9 months | 
| gingival marginal level (mm) | measured in mm | Change from baseline to 9 months | 
| modified sulcus bleeding index | scale from 0-3 | Change from baseline to 9 months | 
| plaque index | scale from 0-3 | Change from baseline to 9 months |