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

NCT02580331 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014S
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Bone defect fill

  Assesed in percentage

  baseline to 9 months

Secondary Outcomes (5)

• modified sulcus bleeding index

  baseline to 9 months

• plaque index

  baseline to 9 months

• pocket probing depth

  baseline to 9 months

• relative vertical clinical attachment level

  baseline to 9 months

• relative horizontal clinical attachment level

  baseline to 9 months

Study Arms (2)

SRP and placebo

PLACEBO COMPARATOR

Oral prophylaxis followed by placement of placebo gel

Drug: SRP and placebo

SRP and 1% metformin

ACTIVE COMPARATOR

Oral prophylaxis followed by placement of 1% metformin gel

Drug: SRP and 1% metformin

Interventions

SRP and placebo DRUG

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

Also known as: Group 1

SRP and placebo

SRP and 1% metformin DRUG

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

Also known as: Group 2

SRP and 1% metformin

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• A R Pradeep, MDS

  GDCRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Government Dental College and Research Institute, Bangalore

Study Record Dates

• First Submitted: October 18, 2015
• First Posted: October 20, 2015
• Study Start: November 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

IN (1)