NCT03043196

1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis

1.2% Rosuvastatin Gel As A Local Drug Delivery Agent In Smokers With Chronic Periodontitis- A Randomized Controlled Clinical Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Government Dental College and Research Institute, Bangalore · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the present study was to evaluate the effects of subgingival delivery of Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic Periodontitis (CP) patients.

Detailed description

Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome this, various systemic and local drug delivered antimicrobials have been used as an adjunct to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2% rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic periodontitis (CP). Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at baseline, 6 and 9 months.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	SRP plus Rosuvastatin gel	SRP followed by Rosuvastatin placement into intrabony defect
DRUG	SRP plus placebo gel	SRP followed by placebo gel placement into intrabony defect

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2017-02-03
• Last updated: 2017-02-03

Locations

1 site across 1 country: India