Clinical Trial: 1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: COMPARATIVE EVALUATION OF CLINICAL EFFICACY OF SUBGINGIVALLY DELIVERED 1.2% ATORVASTATIN AND 1.2% SIMVASTATIN IN TREATMENT OF CHRONIC PERIODONTITIS: A RANDOMIZED CONTROLLE

Brief Summary:

Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis.

Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.


Detailed Summary:
Sponsor: Government Dental College and Research Institute, Bangalore

Current Primary Outcome: Change in Radiographic intra-bony defect depth. [ Time Frame: 9 months from baseline ]

The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Probing depth. [ Time Frame: 9 months from baseline ]
    Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months.
  • Change in Relative attachment level [ Time Frame: 9 months from baseline ]
    Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months.
  • Change in mSBI (gingival index) [ Time Frame: 9 months from baseline ]
    modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure.
  • Change in plaque index [ Time Frame: 9 months from baseline ]
    Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable.


Original Secondary Outcome: Same as current

Information By: Government Dental College and Research Institute, Bangalore

Dates:
Date Received: February 5, 2014
Date Started: February 2013
Date Completion:
Last Updated: February 9, 2014
Last Verified: February 2014