Overview

This trial is active, not recruiting.

Condition intrabony defects in chronic periodontitis
Treatments placebo gel, 1 % metformin gel
Phase phase 2
Sponsor Government Dental College and Research Institute, Bangalore
Start date August 2013
End date February 2014
Trial size 65 participants
Trial identifier NCT02048761, GDCRI/ACM/PG/PhD/2013-14/B

Summary

This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula.
placebo gel
After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula
(Active Comparator)
After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula.
1 % metformin gel
After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.

Primary Outcomes

Measure
Defect depth reduction
time frame: Baseline to 6 months

Secondary Outcomes

Measure
Probing depth
time frame: Baseline to 6 months
Clinical attachment level
time frame: Baseline to 6 months
Modified sulcular bleeding index
time frame: Baseline to 6 months
Plaque index
time frame: Baseline to 6 months

Eligibility Criteria

Male or female participants from 25 years up to 50 years old.

Inclusion Criteria: - Systemically healthy subjects - Sites with probing depth (PD) ≥5 mm - Clinical attachment level (CAL) ≥4 mm - Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included Exclusion Criteria: - Patients with known systemic disease - Known or suspected allergy to the MF/ biguanide group - Patients on systemic MF or other oral antidiabetic therapy - Patients with aggressive periodontitis - Patients with diabetes - Use of tobacco in any form - Alcoholism - Immunocompromised patients - Pregnant or lactating females

Additional Information

Official title Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial
Principal investigator A R Pradeep, M.D.S.
Description Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects. Materials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Government Dental College and Research Institute, Bangalore.