Simvastatin and Metformin in Chronic Periodontitis

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: 1.2% Simvastatin; Drug: 1% Metformin; Drug: Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02372656

GDCRI/ACM/PG/PhD/10C/2013-14

Details and patient eligibility

About

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

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 3 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.

Treatment:

Drug: Placebo gel

1% Metformin

Active Comparator group

Description:

1% metformin gel to be delivered at baseline, 3, 6 and 9 months.

Treatment:

Drug: 1% Metformin

1.2% Simvastatin

Active Comparator group

Description:

1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.

Treatment:

Drug: 1.2% Simvastatin