Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment

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 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients

Detailed Description
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ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin (RSV), are known to be associated with alveolar bone formation and periodontal improvements. Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors, have also come into widespread periodontal regenerative use. The aim of the study is to evaluate and compare the efficacy of open-ﬂap debridement (OFD) with or without PRF or PRF + 1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP) patients. Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3 treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement. Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment (CA) level and IBD depth were recorded at baseline and at 9 months post-operatively.

Official Title
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Platelet-rich Fibrin With 1.2% Rosuvastatin for the 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 PRF and 1.2% Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy with CP diagnosis16 having probing depth (PD) ≥5mm, clinical attachment (CA) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months. Exclusion Criteria: History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufﬁcient platelet count (<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 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>Open flap debridement (OFD) | Procedure: Open flap debridement (OFD)<br>* Oral prophylaxis followed by OFD for treating bone defect<br>|
| Active Comparator: Group 2<br>OFD with Platelet rich fibrin (PRF) | Procedure: OFD with Platelet rich fibrin (PRF)<br>* Oral prophylaxis followed by OFD with PRF placement into the bone defect<br>|
| Active Comparator: Group 3<br>OFD with PRF and 1.2% Rosuvastatin | Procedure: OFD with PRF and 1.2% Rosuvastatin<br>* Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin 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 | 
| 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 |