1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060032
|Principal Investigator:||Avani R Pradeep, MDS||Professor|