Simvastatin and Metformin in Chronic Periodontitis

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Placebo gel; Drug: 1% Metformin; Drug: 1.2% Simvastatin

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 1.2% Simvastatin group

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: November 30, 2014
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (ESTIMATE): February 26, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Simvastatin, Metformin, Chronic periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Metformin; Simvastatin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/10C/2013-14