Skip to main content
OpenTrials
Completed

NCT Number: NCT02580331

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

SRP and placebo

Drug

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

Other names: Group 1

SRP and 1% metformin

Drug

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

Other names: Group 2

Primary outcomes

  1. Bone defect fill

    Time frame: baseline to 9 months

    Assesed in percentage

Secondary outcomes

  1. modified sulcus bleeding index

    Time frame: baseline to 9 months

    scale 0-3

  2. plaque index

    Time frame: baseline to 9 months

    scale 0-3

  3. pocket probing depth

    Time frame: baseline to 9 months

    measured in mm

  4. relative vertical clinical attachment level

    Time frame: baseline to 9 months

    measured in mm

  5. relative horizontal clinical attachment level

    Time frame: baseline to 9 months

    measured in mm

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

1% Metformin Gel as Local Drug Delivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2015
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.