Placebo Gel
DrugPlacebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other names: Placebo group
NCT Number: NCT02372656
This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.
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Notify Me30 year–50 year
All sexes
Interventional
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other names: Placebo group
1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other names: 1% Metformin group
1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other names: 1.2% Simvastatin group
Time frame: Baseline to 6 months and Baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.
Time frame: 3,6 and 9 months
Time frame: 3 , 6 and 9 months
Time frame: 3 , 6 and 9 months
Time frame: 3 , 6 and 9 months
Government Dental College and Research Institute, Bangalore
Other
Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial
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