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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204071
• Other study ID #: GDCRI/ACM/PG/PhD/2/2015-2016IG
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 28, 2017
• Last updated: June 28, 2017
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: June 2017
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• placebo gel
Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
• Aloevera
Oral prophylaxis followed by placement of aloevera gel
• Metformin
Oral prophylaxis followed by placement of metformin gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bone defect fill	Assessed in percentage	baseline - 6 months & baseline -12 months
Secondary	Change in modified sulcus bleeding index	scale 0-3	baseline, 6 & 12 months
Secondary	Change in Plaque index	scale 0-3	baseline, 6 & 12 months
Secondary	Change in pocket probing depth	measured in mm	baseline, 6 & 12 months
Secondary	Clinical attachment level	measured in mm	baseline, 6 & 12 months