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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580331
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014S
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 18, 2015
• Last updated: October 18, 2015
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Furcation Defects
• Periodontitis

Intervention

Drug:
• SRP and placebo
Placement of placebo gel into classII furcation defects after scaling and root planing
• SRP and 1% metformin
Placement of 1% metformin gel into classII furcation defects after scaling and root planing

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone defect fill	Assesed in percentage	baseline to 9 months	No
Secondary	modified sulcus bleeding index	scale 0-3	baseline to 9 months	No
Secondary	plaque index	scale 0-3	baseline to 9 months	No
Secondary	pocket probing depth	measured in mm	baseline to 9 months	No
Secondary	relative vertical clinical attachment level	measured in mm	baseline to 9 months	No
Secondary	relative horizontal clinical attachment level	measured in mm	baseline to 9 months	No