1% Metformin in Moderate and Severe Periodontitis

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

Detailed Description
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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.

Official Title
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Local Drug Delivery of 1% Metformin Gel in Moderate and Severe Periodontitis Subjects: a Randomized Controlled Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Placebo gel
* Drug: 1% Metformin gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month. | Drug: Placebo gel<br>* Placebo gel consist of drug without the active component.<br>* Other names: Placebo group;|
| Active Comparator: 1% Metformin<br>1% Metformin gel. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 month and 6 month. | Drug: 1% Metformin gel<br>* Metformin gel consist of active component.<br>* Other names: 1% Metformin group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in Defect depth |  | at 6 months and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index |  | at 3 , 6 and 9 months | 
| Modified sulcular bleeding index |  | at 3 , 6 and 9 months | 
| Pocket depth |  | at 3 , 6 and 9 months | 
| Clinical attachment level |  | at 3 , 6 and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, Pocket depth, moderate periodontitis, severe periodontitis