NCT03204071

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Government Dental College and Research Institute, Bangalore · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	placebo gel	Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
DRUG	Aloevera	Oral prophylaxis followed by placement of aloevera gel
DRUG	Metformin	Oral prophylaxis followed by placement of metformin gel

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2017-06-29
• Last updated: 2017-06-29