Clinical trial NCT02372656: Simvastatin and Metformin in Chronic Periodontitis
Official title: Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Keywords: Simvastatin, Metformin, Chronic periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 98
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
timeFrame: Baseline to 6 months and Baseline to 9 months
Secondary outcomes:
measure: Plaque index will be measured at 3, 6 and 9 months
timeFrame: 3,6 and 9 months
measure: Modified sulcular bleeding index at 3, 6 and 9 months
timeFrame: 3 , 6 and 9 months
measure: Probing pocket depth at 3, 6 and 9 months
timeFrame: 3 , 6 and 9 months
measure: Clinical attachment level at 3, 6 and 9 months
timeFrame: 3 , 6 and 9 months
Other outcomes:
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