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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
SRP and placebo
SRP and 1% metformin
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Government Dental College and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

SRP and placebo

SRP and 1% metformin

Arm Description

Oral prophylaxis followed by placement of placebo gel

Oral prophylaxis followed by placement of 1% metformin gel

Outcomes

Primary Outcome Measures

Bone defect fill
Assesed in percentage

Secondary Outcome Measures

modified sulcus bleeding index
scale 0-3
plaque index
scale 0-3
pocket probing depth
measured in mm
relative vertical clinical attachment level
measured in mm
relative horizontal clinical attachment level
measured in mm

Full Information

First Posted
October 18, 2015
Last Updated
October 18, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
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1. Study Identification

Unique Protocol Identification Number
NCT02580331
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRP and placebo
Arm Type
Placebo Comparator
Arm Description
Oral prophylaxis followed by placement of placebo gel
Arm Title
SRP and 1% metformin
Arm Type
Active Comparator
Arm Description
Oral prophylaxis followed by placement of 1% metformin gel
Intervention Type
Drug
Intervention Name(s)
SRP and placebo
Other Intervention Name(s)
Group 1
Intervention Description
Placement of placebo gel into classII furcation defects after scaling and root planing
Intervention Type
Drug
Intervention Name(s)
SRP and 1% metformin
Other Intervention Name(s)
Group 2
Intervention Description
Placement of 1% metformin gel into classII furcation defects after scaling and root planing
Primary Outcome Measure Information:
Title
Bone defect fill
Description
Assesed in percentage
Time Frame
baseline to 9 months
Secondary Outcome Measure Information:
Title
modified sulcus bleeding index
Description
scale 0-3
Time Frame
baseline to 9 months
Title
plaque index
Description
scale 0-3
Time Frame
baseline to 9 months
Title
pocket probing depth
Description
measured in mm
Time Frame
baseline to 9 months
Title
relative vertical clinical attachment level
Description
measured in mm
Time Frame
baseline to 9 months
Title
relative horizontal clinical attachment level
Description
measured in mm
Time Frame
baseline to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A R Pradeep, MDS
Organizational Affiliation
GDCRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India

12. IPD Sharing Statement

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

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