Simvastatin and Metformin in Chronic Periodontitis

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: 1.2% Simvastatin; Drug: Placebo gel; Drug: 1% Metformin

• Registration Number: NCT02372656
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2013-12
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-11-30
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.2% Simvastatin	1.2% Simvastatin	1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.
Placebo Group	Placebo gel	Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.
1% Metformin	1% Metformin	1% metformin gel to be delivered at baseline, 3, 6 and 9 months.

Primary Outcome Measures

Name	Time	Method
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months	Baseline to 6 months and Baseline to 9 months	Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.

Secondary Outcome Measures

Name	Time	Method
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