Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600520
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014X
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 6, 2015
• Last updated: November 11, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• SRP with RSV gel LDD
After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
• SRP with ATV gel LDD
After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
• SRP with placebo gel LDD
After SRP, placebo gel was delivered subgingivally into the pocket

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No