CClinicalTrials.gg
Sign In
CompletedNCT02580331Updated Oct 20, 2015

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

A Phase 2/3 interventional study of SRP and placebo and SRP and 1% metformin in Chronic Periodontitis, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Periodontitis
03

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Placebo comparator
    SRP and placebo

    Oral prophylaxis followed by placement of placebo gel

    Drug: SRP and placebo

  • Active comparator
    SRP and 1% metformin

    Oral prophylaxis followed by placement of 1% metformin gel

    Drug: SRP and 1% metformin

Interventions

  • DrugSRP and placebo

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

    Also known as: Group 1

  • DrugSRP and 1% metformin

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

    Also known as: Group 2

05

What researchers measure

Primary outcomes

  1. Bone defect fill

    Assesed in percentage

    Time frame: baseline to 9 months

Secondary outcomes

  1. modified sulcus bleeding index

    scale 0-3

    Time frame: baseline to 9 months

  2. plaque index

    scale 0-3

    Time frame: baseline to 9 months

  3. pocket probing depth

    measured in mm

    Time frame: baseline to 9 months

  4. relative vertical clinical attachment level

    measured in mm

    Time frame: baseline to 9 months

  5. relative horizontal clinical attachment level

    measured in mm

    Time frame: baseline to 9 months

06

Study locations

1 site
  • Government Dental College and Research Institute
    Bangalore, Karnataka 560002, India
07

Registry details

Key details

Study ID
NCT02580331
Lead sponsor
Government Dental College and Research Institute, Bangalore
Responsible party
Dr. A R Pradeep (Professor, Government Dental College and Research Institute, Bangalore, Government Dental College and Research Institute, Bangalore) — Principal investigator
First posted
Oct 20, 2015
Start date
Nov 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Oct 20, 2015

Study contacts

A R Pradeep, MDS
principal investigator · GDCRI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontitis→

Other studies from this sponsor

Government Dental College and Research Institute, Bangalore

Start the discussion