Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis

Study Overview
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Brief Summary
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This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.

Detailed Description
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Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects. Materials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.

Official Title
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Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial

Conditions
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Intrabony Defects in Chronic 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 Sites with probing depth (PD) ≥5 mm Clinical attachment level (CAL) ≥4 mm Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included Exclusion Criteria: Patients with known systemic disease Known or suspected allergy to the MF/ biguanide group Patients on systemic MF or other oral antidiabetic therapy Patients with aggressive periodontitis Patients with diabetes Use of tobacco in any form Alcoholism Immunocompromised patients Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 25 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula. | Drug: Placebo gel<br>* After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula<br>|
| Active Comparator: 1% Metformin<br>After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula. | Drug: 1 % Metformin gel<br>* After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defect depth reduction | The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth is measured from baseline to 3 months and 6 months in both control and test group. | Baseline to 6 months | 
| Clinical attachment level | Clinical attachment level is measured from baseline to 3 months and 6 months in both control and test group. | Baseline to 6 months | 
| Modified sulcular bleeding index | Modified sulcular bleeding index is measured from baseline to 3 months and 6 months in both control and test group. | Baseline to 6 months | 
| Plaque index | Full mouth and site specific plaque index is measured from baseline to 3 months and 6 months in both control and test group. | Baseline to 6 months |