Simvastatin and Metformin in Chronic Periodontitis

Government Dental College and Research Institute, Bangalore98 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Periodontitis

Interventions

Placebo gelDRUG

Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.

1% MetforminDRUG

1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.

1.2% SimvastatinDRUG

1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 months and Baseline to 9 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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