Clinical trial NCT02580331: 1% Metformin Gel in the Treatment of Class II Furcation Defects
Official title: 1% Metformin Gel as Local Drug Delivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone defect fill
timeFrame: baseline to 9 months
Secondary outcomes:
measure: modified sulcus bleeding index
timeFrame: baseline to 9 months
measure: plaque index
timeFrame: baseline to 9 months
measure: pocket probing depth
timeFrame: baseline to 9 months
measure: relative vertical clinical attachment level
timeFrame: baseline to 9 months
measure: relative horizontal clinical attachment level
timeFrame: baseline to 9 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
affiliation: GDCRI
name: A R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References: