Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: SRP with RSV gel LDD; Drug: SRP with ATV gel LDD; Drug: SRP with placebo gel LDD

• Registration Number: NCT02600520
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-11
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin Group	SRP with RSV gel LDD	SRP followed by RSV gel LDD
Atorvastatin Group	SRP with ATV gel LDD	SRP followed by ATV gel LDD
Placebo group	SRP with placebo gel LDD	SRP followed by placebo gel LDD

Primary Outcome Measures

Name	Time	Method
Change in intrabony defect depth from baseline to 6 months	Baseline to 6 months	Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured

Secondary Outcome Measures

Name	Time	Method
Change in plaque index (PI) from baseline to 6 months	Baseline to 6 months	Reduction in plaque index (PI) from baseline to 6 months wiil be measured
Change in modified sulcus bleeding index (mSBI) from baseline to 6 months	Baseline to 6 months	Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured
Change in probing depth (PD) from baseline to 6 months	Baseline to 6 months	Reduction in probing depth (PD) from baseline to 6 months wiil be measured
Change in clinical attachment (CA) level from baseline to 6 months	Baseline to 6 months	Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured