Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

Study Overview
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Brief Summary
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The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

Detailed Description
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90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

Official Title
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Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Conditions
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Three Wall Intrabony Defects in Chronic Periodontitis

Intervention / Treatment
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* Drug: Platelet rich fibrin and simvastatin
* Biological: Platelet rich fibrin
* Procedure: Open Flap Debridement alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with the diagnosis of chronic periodontitis presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA]) interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth Exclusion Criteria: Subjects, with the diagnosis of aggressive periodontitis, with known systemic illness and taking medications known to affect the outcomes of periodontal therapy insufficient platelet count (< 200,000/mm3), pregnancy / lactation use of any form of tobacco unacceptable oral hygiene (if plaque index [PI] (Silness & Loe 1964) >1.5) after the reevaluation of phase I therapy teeth with furcation defects non-vital mobility of tooth ≥ Grade II

Ages Eligible for Study
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Minimum Age: 25 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: PRF and SMV Group<br>sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin | Drug: Platelet rich fibrin and simvastatin<br>* Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.<br>|
| Sham Comparator: PRF Group<br>sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin | Biological: Platelet rich fibrin<br>* Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.<br>|
| Other: OFD Group<br>sites treated with Open Flap Debridement i.e. conventional flap surgery | Procedure: Open Flap Debridement alone<br>* Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure of the study was defect depth reduction evaluated radiographically |  | At baseline and 9 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth |  | At baseline and 9 month after surgery | 
| Relative Attachment Level |  | At baseline and 9 month after syrgery | 
| modified Sulcul Bleeding Index |  | At baseline and 9 month after surgery | 
| Plaque Index |  | At baseline and 9 month after surgery |