Skip to main content
OpenTrials
Completed

NCT Number: NCT02985099

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRP plus Rosuvastatin gel

Drug

SRP followed by 1.2% Rosuvastatin placement into intrabony defect

SRP plus placebo gel

Drug

SRP followed by placebo gel placement into intrabony defect

Primary outcomes

  1. Defect depth reduction (%)

    Time frame: Change from baseline to 9 months

    Assessed in percentage

Secondary outcomes

  1. probing depth (mm)

    Time frame: Change from baseline to 9 months

    measured in mm

  2. clinical attachment level (mm)

    Time frame: Change from baseline to 9 months

    measured in mm

  3. modified sulcus bleeding index

    Time frame: Change from baseline to 9 months

    scale from 0-3

  4. plaque index

    Time frame: Change from baseline to 9 months

    scale from 0-3

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.