Simvastatin and Metformin in Chronic Periodontitis
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|ClinicalTrials.gov Identifier: NCT02372656|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Drug: Placebo gel Drug: 1% Metformin Drug: 1.2% Simvastatin||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Placebo Comparator: Placebo Group
Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.
Drug: Placebo gel
Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other Name: Placebo group
Active Comparator: 1% Metformin
1% metformin gel to be delivered at baseline, 3, 6 and 9 months.
Drug: 1% Metformin
1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other Name: 1% Metformin group
Active Comparator: 1.2% Simvastatin
1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.
Drug: 1.2% Simvastatin
1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other Name: 1.2% Simvastatin group
- 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.
- 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 ]