Comparison of Alendronate With Atorvastatin in Chronic Periodontitis
- Conditions
- Chronic Periodontitis
- Interventions
- Registration Number
- NCT02455869
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atorvastatin group SRP and Atorvastatin SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally Alendronate Group SRP and Alendronate Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally Placebo group SRP and Placebo gel SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket
- Primary Outcome Measures
Name Time Method Change in defect depth reduction from baseline to 6 months and from baseline to 9 months Baseline to 6 months and Baseline to 9 months Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval
- Secondary Outcome Measures
Name Time Method Plaque index 3,6 and 9 months Plaque index will be measured at 3, 6 and 9 months
Clinical attachment level 3,6 and 9 months] Clinical attachment level will be measured at 3, 6 and 9 months
Modified sulcus bleeding index 3,6 and 9 months] Modified sulcus bleeding index will be measured at 3, 6 and 9 months
Probing pocket depth 3,6 and 9 months] Probing pocket depth will be measured at 3, 6 and 9 months