Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment

Study Overview
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Brief Summary
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The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.

Detailed Description
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Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis. Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.

Official Title
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Comparative Evaluation of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Treatment of 2/3-walled Intrabony Defects in Chronic Periodontitis Subjects: a Randomized Controlled Clinical Trial

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Open flap debridement (OFD)
* Biological: OFD with PRF
* Drug: OFD with ALN
* Drug: OFD with ATV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included Exclusion Criteria: Patients with a known systemic disease Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group On systemic ALN/ bisphosphonates or ATV/statin group With aggressive periodontitis Who used tobacco in any form Alcoholics Immunocompromised patients And pregnant or lactating females were excluded from the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

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: Open flap debridement group<br>SRP with Open flap debridement (OFD) alone for treating intrabony defect | Procedure: Open flap debridement (OFD)<br>* Oral prophylaxis followed by Open flap debridement (OFD)<br>|
| Active Comparator: PRF group<br>SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect | Biological: OFD with PRF<br>* Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect<br>|
| Active Comparator: Alendronate group<br>SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect | Drug: OFD with ALN<br>* Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect<br>|
| Active Comparator: Atorvastatin group<br>SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect | Drug: OFD with ATV<br>* Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel 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 (DDR) |  | Change from baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in clinical attachment level (CAL) |  | Change from baseline to 9 months | 
| change in probing pocket depths (PPD) |  | Change from baseline to 9 months | 
| change in plaque index (PI) |  | Change from baseline to 9 months |