Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: SRP with RSV gel LDD; Drug: SRP with ATV gel LDD; Drug: SRP with placebo gel LDD

Study type: Interventional

Funder types: Other

Identifiers

NCT02600520

GDCRI/ACM/PG/PhD/2/2013-2014X

Details and patient eligibility

About

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Full description

Background: Rosuvastatin (RSV) and Atorvastatin (ATV) 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 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).

Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.

Enrollment: 45 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemically healthy patients with PD ≥5mm or CA loss ≥4mm 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 statin group;
• on systemic statin therapy;
• with aggressive periodontitis;
• who used tobacco in any form;
• alcoholics;
• immunocompromised patients;
• pregnant or lactating females were excluded from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Rosuvastatin Group

Active Comparator group

Description:

SRP followed by RSV gel LDD

Treatment:

Drug: SRP with RSV gel LDD

Atorvastatin Group

Active Comparator group

Description:

SRP followed by ATV gel LDD

Treatment:

Drug: SRP with ATV gel LDD

Placebo group

Placebo Comparator group

Description:

SRP followed by placebo gel LDD

Treatment:

Drug: SRP with placebo gel LDD