1% Metformin in Moderate and Severe Periodontitis

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Drug: Placebo gel; Drug: 1% Metformin gel

• Registration Number: NCT02274090
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe periodontitis subject.

Detailed Description

Metformin (MF) has stimulating effect of osteoblastic lineages. In the present study seventy subjects were categorized into two treatment groups: Scaling and root planing (SRP) plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), 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. PD, CAL and defect depth reduction was evaluated in initial pocket depth of ≥5mm and ≥7mm subgroup within placebo and MF group.

Mean probing depth reduction and mean clinical attachment level gain was found to greater in MF group than placebo group at all visits. Significantly greater mean percentage of defect depth reduction was found in MF group than the placebo sites in both ≥5mm and ≥7mm of initial periodontal pocket depth. In MF group improvement in clinical parameter were similar in both the sites, with slightly better improvement in clinical parameters in initial pocket depth ≥7mm with respect to CAL, IBD and DDR% while PD was significantly reduced in initial pocket depth of ≥7mm.

There was greater decrease in mSBI and PD and more CAL gain with significant IBD depth reduction at the sites treated with SRP plus locally delivered MF in chronic periodontitis subjects with intrabony defects as compared to placebo and effect of MF was similar in initial moderate periodontal pockets and deep pocket depths.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-22
• Last Update Submitted: 2014-10-22
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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, those on systemic MF therapy, subjects with aggressive periodontitis, immunocompromised subjects, use of tobacco in any form, alcoholics, lactating and pregnant females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo gel	Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.
1% Metformin	1% Metformin gel	1% Metformin gel. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month.

Primary Outcome Measures

Name	Time	Method
Percentage reduction in Defect depth	at 6 months and 9 months

Secondary Outcome Measures

Name	Time	Method
Modified sulcular bleeding index	at 3 , 6 and 9 months
Clinical attachment level	at 3 , 6 and 9 months
Plaque index	at 3 , 6 and 9 months
Pocket depth	at 3 , 6 and 9 months