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

NCT02985099 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014DK
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Defect depth reduction (%)

  Assessed in percentage

  Change from baseline to 9 months

Secondary Outcomes (4)

• probing depth (mm)

  Change from baseline to 9 months

• clinical attachment level (mm)

  Change from baseline to 9 months

• modified sulcus bleeding index

  Change from baseline to 9 months

• plaque index

  Change from baseline to 9 months

Study Arms (2)

Rosuvastatin group

ACTIVE COMPARATOR

Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects

Drug: SRP plus Rosuvastatin gel

Placebo group

PLACEBO COMPARATOR

Oral prophylaxis followed by placebo gel placement in intrabony defects

Drug: SRP plus placebo gel

Interventions

SRP plus Rosuvastatin gel DRUG

SRP followed by 1.2% Rosuvastatin placement into intrabony defect

Rosuvastatin group

SRP plus placebo gel DRUG

SRP followed by placebo gel placement into intrabony defect

Placebo group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Dept of Periodontology

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 7, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

IN (1)