Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: SRP with RSV gel LDD; Drug: SRP with ATV gel LDD; Drug: SRP with placebo gel LDD

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rosuvastatin Group; SRP followed by RSV gel LDD	Drug: SRP with RSV gel LDD; After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
Active Comparator: Atorvastatin Group; SRP followed by ATV gel LDD	Drug: SRP with ATV gel LDD; After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
Placebo Comparator: Placebo group; SRP followed by placebo gel LDD	Drug: SRP with placebo gel LDD; After SRP, placebo gel was delivered subgingivally into the pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intrabony defect depth from baseline to 6 months	Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plaque index (PI) from baseline to 6 months	Reduction in plaque index (PI) from baseline to 6 months wiil be measured	Baseline to 6 months
Change in modified sulcus bleeding index (mSBI) from baseline to 6 months	Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured	Baseline to 6 months
Change in probing depth (PD) from baseline to 6 months	Reduction in probing depth (PD) from baseline to 6 months wiil be measured	Baseline to 6 months
Change in clinical attachment (CA) level from baseline to 6 months	Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 11, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014X