NCT02455869

Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 104 (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 efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Detailed description

Background: 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 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis. Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth \[PD\], and clinical attachment level \[CAL\]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	SRP and Placebo gel	After SRP, placebo gel was delivered subgingivally into the pocket
DRUG	SRP and Atorvastatin	After SRP, Atorvastatin gel was delivered subgingivally into the pocket
DRUG	SRP and Alendronate	After SRP, Alendronate gel was delivered subgingivally into the pocket

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2015-05-28
• Last updated: 2015-05-28