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

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Aloevera; Drug: placebo gel; Drug: Metformin

• Registration Number: NCT03204071
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-06
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-28
• Last Update Submitted: 2017-06-28
• Study First Posted: 2017-06-29
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Aloevera	Aloe vera gel to be delivered at baseline, 6 and 12 months.
Group 1	placebo gel	Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.
Group 3	Metformin	1% metformin gel to be delivered at baseline, 6 and 12 months.

Primary Outcome Measures

Name	Time	Method
Change in Bone defect fill	baseline - 6 months & baseline -12 months	Assessed in percentage

Secondary Outcome Measures

Name	Time	Method
Change in pocket probing depth	baseline, 6 & 12 months	measured in mm
Change in modified sulcus bleeding index	baseline, 6 & 12 months	scale 0-3
Clinical attachment level	baseline, 6 & 12 months	measured in mm
Change in Plaque index	baseline, 6 & 12 months	scale 0-3