Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

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 and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Detailed Description
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Background: Rosuvastatin (RSV) and Atorvastatin (ATV) 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 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP). Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.

Official Title
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1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in 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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* Drug: SRP with RSV gel LDD
* Drug: SRP with ATV gel LDD
* Drug: SRP with placebo gel LDD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients with PD ≥5mm or CA loss ≥4mm 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 statin group; on systemic statin therapy; with aggressive periodontitis; who used tobacco in any form; alcoholics; immunocompromised patients; 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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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: Rosuvastatin Group<br>SRP followed by RSV gel LDD | Drug: SRP with RSV gel LDD<br>* After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket<br>|
| Active Comparator: Atorvastatin Group<br>SRP followed by ATV gel LDD | Drug: SRP with ATV gel LDD<br>* After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket<br>|
| Placebo Comparator: Placebo group<br>SRP followed by placebo gel LDD | Drug: SRP with placebo gel LDD<br>* After SRP, placebo gel was delivered subgingivally into the pocket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intrabony defect depth from baseline to 6 months | Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plaque index (PI) from baseline to 6 months | Reduction in plaque index (PI) from baseline to 6 months wiil be measured | Baseline to 6 months | 
| Change in modified sulcus bleeding index (mSBI) from baseline to 6 months | Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured | Baseline to 6 months | 
| Change in probing depth (PD) from baseline to 6 months | Reduction in probing depth (PD) from baseline to 6 months wiil be measured | Baseline to 6 months | 
| Change in clinical attachment (CA) level from baseline to 6 months | Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured | Baseline to 6 months |