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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02580331
Enrollment
64
Registered
2015-10-20
Start date
2014-11-30
Completion date
2015-09-30
Last updated
2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

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.

Interventions

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

DRUGSRP and 1% metformin

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

Sponsors

Government Dental College and Research Institute, Bangalore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Bone defect fillbaseline to 9 monthsAssesed in percentage

Secondary

MeasureTime frameDescription
modified sulcus bleeding indexbaseline to 9 monthsscale 0-3
plaque indexbaseline to 9 monthsscale 0-3
pocket probing depthbaseline to 9 monthsmeasured in mm
relative vertical clinical attachment levelbaseline to 9 monthsmeasured in mm
relative horizontal clinical attachment levelbaseline to 9 monthsmeasured in mm

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026