Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- SRP and Placebo gel
- Conditions
- Chronic Periodontitis
- Sponsor
- Government Dental College and Research Institute, Bangalore
- Enrollment
- 104
- Primary Endpoint
- Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore
Eligibility Criteria
Inclusion Criteria
- •Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm 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 the ALN/bisphosphonate group and ATV/statin group;
- •on systemic ALN/bisphosphonate and therapy ATV/statin group;
- •with aggressive periodontitis;
- •who used tobacco in any form;
- •alcoholics;
- •immunocompromised patients;
- •and pregnant or lactating females were excluded from the study
Arms & Interventions
Placebo group
SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
Intervention: SRP and Placebo gel
Atorvastatin group
SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally
Intervention: SRP and Atorvastatin
Alendronate Group
Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally
Intervention: SRP and Alendronate
Outcomes
Primary Outcomes
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
Time Frame: Baseline to 6 months and Baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval
Secondary Outcomes
- Plaque index(3,6 and 9 months)
- Clinical attachment level(3,6 and 9 months])
- Modified sulcus bleeding index(3,6 and 9 months])
- Probing pocket depth(3,6 and 9 months])