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

Type2 Diabetes Clinical Trial

Official title:

1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985099
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014DK
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 4, 2016
• Last updated: December 4, 2016
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis
• Type2 Diabetes

Intervention

Drug:
• SRP plus Rosuvastatin gel
SRP followed by 1.2% Rosuvastatin placement into intrabony defect
• SRP plus placebo gel
SRP followed by placebo gel placement into intrabony defect

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defect depth reduction (%)	Assessed in percentage	Change from baseline to 9 months	No
Secondary	probing depth (mm)	measured in mm	Change from baseline to 9 months	No
Secondary	clinical attachment level (mm)	measured in mm	Change from baseline to 9 months	No
Secondary	modified sulcus bleeding index	scale from 0-3	Change from baseline to 9 months	No
Secondary	plaque index	scale from 0-3	Change from baseline to 9 months	No