Clinical Trial: Simvastatin and Metformin in Chronic Periodontitis

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

Official Title: Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial

Brief Summary: This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.

Detailed Summary:

Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.

Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software

Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group.

Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.


Sponsor: Government Dental College and Research Institute, Bangalore

Current Primary Outcome: Change in defect depth reduction from baseline to 6 months and from baseline to 9 months [ Time Frame: Baseline to 6 months and Baseline to 9 months ]

Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Plaque index will be measured at 3, 6 and 9 months [ Time Frame: 3,6 and 9 months ]
  • Modified sulcular bleeding index at 3, 6 and 9 months [ Time Frame: 3 , 6 and 9 months ]
  • Probing pocket depth at 3, 6 and 9 months [ Time Frame: 3 , 6 and 9 months ]
  • Clinical attachment level at 3, 6 and 9 months [ Time Frame: 3 , 6 and 9 months ]


Original Secondary Outcome: Same as current

Information By: Government Dental College and Research Institute, Bangalore

Dates:
Date Received: November 30, 2014
Date Started: December 2013
Date Completion:
Last Updated: February 20, 2015
Last Verified: February 2015