1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Type2 Diabetes; Chronic Periodontitis
• Interventions: Drug: SRP plus Rosuvastatin gel; Drug: SRP plus placebo gel

• Registration Number: NCT02985099
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.

Detailed Description

Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.

Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group). At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-12
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-04
• Last Update Submitted: 2016-12-04
• Study First Posted: 2016-12-07
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
• Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy

Exclusion Criteria

• Patients with any other known systemic disease
• Patients on systemic statin therapy
• Known or suspected allergy to statin supplementation
• Patients with aggressive periodontitis
• Tobacco use in any form, smokers, alcoholics
• Immunocompromised patients
• Pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin group	SRP plus Rosuvastatin gel	Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
Placebo group	SRP plus placebo gel	Oral prophylaxis followed by placebo gel placement in intrabony defects

Primary Outcome Measures

Name	Time	Method
Defect depth reduction (%)	Change from baseline to 9 months	Assessed in percentage

Secondary Outcome Measures

Name	Time	Method
plaque index	Change from baseline to 9 months	scale from 0-3
probing depth (mm)	Change from baseline to 9 months	measured in mm
clinical attachment level (mm)	Change from baseline to 9 months	measured in mm
modified sulcus bleeding index	Change from baseline to 9 months	scale from 0-3

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India