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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-09-30

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 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.

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Detailed Description

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SRP and placebo

Oral prophylaxis followed by placement of placebo gel

Group Type PLACEBO_COMPARATOR

SRP and placebo

Intervention Type DRUG

Placement of placebo gel into classII furcation defects after scaling and root planing

SRP and 1% metformin

Oral prophylaxis followed by placement of 1% metformin gel

Group Type ACTIVE_COMPARATOR

SRP and 1% metformin

Intervention Type DRUG

Placement of 1% metformin gel into classII furcation defects after scaling and root planing

Interventions

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SRP and placebo

Placement of placebo gel into classII furcation defects after scaling and root planing

Intervention Type DRUG

SRP and 1% metformin

Placement of 1% metformin gel into classII furcation defects after scaling and root planing

Intervention Type DRUG

Other Intervention Names

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Group 1 Group 2

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes