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

Phase 2

• Conditions: Intrabony Defects in Chronic Periodontitis
• Interventions: Drug: Placebo gel; Drug: 1 % Metformin gel

• Registration Number: NCT02048761
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-29
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Defect depth reduction	Baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Probing depth	Baseline to 6 months	Probing depth is measured from baseline to 3 months and 6 months in both control and test group.
Clinical attachment level	Baseline to 6 months	Clinical attachment level is measured from baseline to 3 months and 6 months in both control and test group.
Modified sulcular bleeding index	Baseline to 6 months	Modified sulcular bleeding index is measured from baseline to 3 months and 6 months in both control and test group.
Plaque index	Baseline to 6 months	Full mouth and site specific plaque index is measured from baseline to 3 months and 6 months in both control and test group.

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India