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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02372656

Enrollment

Registered

2015-02-26

Start date

2013-12-31

Completion date

2014-08-31

Last updated

2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

Simvastatin, Metformin, Chronic periodontitis

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.

Interventions

DRUGPlacebo gel

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

DRUG1% Metformin

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

DRUG1.2% Simvastatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026