NCT02600520

Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Government Dental College and Research Institute, Bangalore · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	SRP with RSV gel LDD	After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
DRUG	SRP with ATV gel LDD	After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
DRUG	SRP with placebo gel LDD	After SRP, placebo gel was delivered subgingivally into the pocket

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-11-09
• Last updated: 2015-11-13