1% Metformin Gel in the Treatment of Class II Furcation Defects

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: SRP and 1% metformin; Drug: SRP and placebo

• Registration Number: NCT02580331
• 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 favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.

Detailed Description

Background: 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 favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.

Methods: Sixty four patients with single mandibular buccal class II furcation defects were categorized into two treatment groups: SRP plus 1% MF (group 1) and SRP plus placebo (group 2). Clinical parameters were recorded at baseline, 3 months, 6 months, and 9 months, and radiographic parameters were recorded at baseline, 6 months, and 9 months. Defect fill at baseline, 6 months, and 9 months was calculated on standardized radiographs using image analysis software.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-18
• Study First Submitted QC: 2015-10-18
• Last Update Submitted: 2015-10-18
• Study First Posted: 2015-10-20
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. the presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first molars with a radiolucency in the furcation area on an intraoral periapical radiograph with PD≥ 5 mm and horizontal PD≥3 mm following phase I therapy (SRP)

Exclusion Criteria

• patients with known systemic disease; patients with known or suspected allergy to the MF; patients receiving systemic MF therapy; patients with aggressive periodontitis; patients using tobacco in any form; patients with alcoholism; patients who were immunocompromised; pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP and 1% metformin	SRP and 1% metformin	Oral prophylaxis followed by placement of 1% metformin gel
SRP and placebo	SRP and placebo	Oral prophylaxis followed by placement of placebo gel

Primary Outcome Measures

Name	Time	Method
Bone defect fill	baseline to 9 months	Assesed in percentage

Secondary Outcome Measures

Name	Time	Method
plaque index	baseline to 9 months	scale 0-3
modified sulcus bleeding index	baseline to 9 months	scale 0-3
pocket probing depth	baseline to 9 months	measured in mm
relative vertical clinical attachment level	baseline to 9 months	measured in mm
relative horizontal clinical attachment level	baseline to 9 months	measured in mm

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India