Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

NCT ID: NCT02600520

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-05-31

Brief Summary

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.

Detailed 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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rosuvastatin Group

SRP followed by RSV gel LDD

Group Type: ACTIVE_COMPARATOR

SRP with RSV gel LDD

Intervention Type: DRUG

After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket

Atorvastatin Group

SRP followed by ATV gel LDD

Group Type: ACTIVE_COMPARATOR

SRP with ATV gel LDD

Intervention Type: DRUG

After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket

Placebo group

SRP followed by placebo gel LDD

Group Type: PLACEBO_COMPARATOR

SRP with placebo gel LDD

Intervention Type: DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

Interventions

SRP with RSV gel LDD

After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket

Intervention Type: DRUG

SRP with ATV gel LDD

After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket

Intervention Type: DRUG

SRP with placebo gel LDD

After SRP, placebo gel was delivered subgingivally into the pocket

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role: lead

Responsible Party

Dr. A R Pradeep

Professor & Head, Department of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id