1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
|ClinicalTrials.gov Identifier: NCT02060032|
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Drug: 1.2% Atorvastatin local drug delivery Drug: 1.2% simvastatin local drug delivery Drug: Placebo local drug delivery||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||COMPARATIVE EVALUATION OF CLINICAL EFFICACY OF SUBGINGIVALLY DELIVERED 1.2% ATORVASTATIN AND 1.2% SIMVASTATIN IN TREATMENT OF CHRONIC PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Active Comparator: Atorvastatin
1.2% atorvastatin local drug delivery
Drug: 1.2% Atorvastatin local drug delivery
Sham Comparator: Simvastatin
1.2% simvastatin local drug delivery
Drug: 1.2% simvastatin local drug delivery
Placebo Comparator: Placebo
Placebo local drug delivery
Drug: Placebo local drug delivery
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060032
|Principal Investigator:||Avani R Pradeep, MDS||Professor|