Simvastatin and Metformin in Chronic Periodontitis

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

Detailed Description
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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.

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

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Placebo gel
* Drug: 1% Metformin
* Drug: 1.2% Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy subjects Pocket depth ≥ 5 mm Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months Exclusion Criteria: Subjects allergic to MF or SMV Those on systemic MF or SMV therapy Subjects with aggressive periodontitis Immunocompromised subjects Use of tobacco in any form, alcoholics Lactating and pregnant females

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months. | Drug: Placebo gel<br>* Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.<br>* Other names: Placebo group;|
| Active Comparator: 1% Metformin<br>1% metformin gel to be delivered at baseline, 3, 6 and 9 months. | Drug: 1% Metformin<br>* 1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.<br>* Other names: 1% Metformin group;|
| Active Comparator: 1.2% Simvastatin<br>1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months. | Drug: 1.2% Simvastatin<br>* 1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.<br>* Other names: 1.2% Simvastatin group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in defect depth reduction from baseline to 6 months and from baseline to 9 months | Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval. | Baseline to 6 months and Baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index will be measured at 3, 6 and 9 months |  | 3,6 and 9 months | 
| Modified sulcular bleeding index at 3, 6 and 9 months |  | 3 , 6 and 9 months | 
| Probing pocket depth at 3, 6 and 9 months |  | 3 , 6 and 9 months | 
| Clinical attachment level at 3, 6 and 9 months |  | 3 , 6 and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simvastatin, Metformin, Chronic periodontitis