Comparison of Alendronate With Atorvastatin in Chronic Periodontitis

Condition(s) targeted: Chronic Periodontitis

Intervention: SRP and Placebo gel (Drug); SRP and Atorvastatin (Drug); SRP and Alendronate (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Government Dental College and Research Institute, Bangalore

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Change in defect depth reduction from baseline to 6 months and from baseline to 9 months

Secondary outcome:

Plaque index

Modified sulcus bleeding index

Probing pocket depth

Clinical attachment level

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.

Minimum age: 30 Years. Maximum age: 50 Years. Gender(s): Both.

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

Starting date: July 2014
Last updated: May 25, 2015