Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

Study Overview
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Brief Summary
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Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favorable effect on alveolar bone. AloeVera Gel had also been used in dentistry and showed good results.The present study aims to explore the efficacy of 1% MF gel and aloe vera gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of subjects with chronic periodontitis (CP) with intrabody defects.

Detailed Description
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Aim: To compare the efficacy of locally delivered 1% MF gel and aloe vera 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: Placebo, aloevera gel(AV) and 1% Metformin (MF)after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 6 and 12 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 12 months interval using computer-aided software Results: Mean PPD reduction and mean CAL gain was found to greater in MF group than AV and placebo group at all visits. The DDR% was greater in MF group as compared to AV and placebo group. Conclusion: There was a greater decrease in mSBI and PPD and more CAL gain at the sites treated with AV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The significant IBD depth reduction effect was seen in case of MFgroup.

Official Title
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COMPARATIVE EVALUATION OF SUBGINGIVALLY DELIVERED 1% METFORMIN AND ALOE VERA GEL IN TREATMENT OF INTRABODY DEFECTS IN CHRONIC PERIODONTITIS SUBJECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: placebo gel
* Drug: Aloevera
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients with sites showing PPD ≥ 5 mm, CAL ≥ 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 AV Those on systemic MF or AV 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: 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months. | Drug: placebo gel<br>* Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.<br>* Other names: inactive drug;|
| Active Comparator: Group 2<br>Aloe vera gel to be delivered at baseline, 6 and 12 months. | Drug: Aloevera<br>* Oral prophylaxis followed by placement of aloevera gel<br>* Other names: AV;|
| Active Comparator: Group 3<br>1% metformin gel to be delivered at baseline, 6 and 12 months. | Drug: Metformin<br>* Oral prophylaxis followed by placement of metformin gel<br>* Other names: MF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bone defect fill | Assessed in percentage | baseline - 6 months & baseline -12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in modified sulcus bleeding index | scale 0-3 | baseline, 6 & 12 months | 
| Change in Plaque index | scale 0-3 | baseline, 6 & 12 months | 
| Change in pocket probing depth | measured in mm | baseline, 6 & 12 months | 
| Clinical attachment level | measured in mm | baseline, 6 & 12 months |