Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis

Phase 2UnknownNCT02048761

Government Dental College and Research Institute, Bangalore65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Intrabony Defects in Chronic Periodontitis

Interventions

Placebo gelDRUG

After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula

1 % Metformin gelDRUG

After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Government Dental College and Research Institute

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

Defect depth reduction

The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group.