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

Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Intrabony Defects in Chronic Periodontitis
• Intervention / Treatment: Drug: Placebo gel; Drug: 1 % Metformin 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 Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula.	Drug: 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: 1% Metformin; After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula.	Drug: 1 % Metformin gel; After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore
• Investigators: Principal Investigator: A R Pradeep, M.D.S., Govt Dental College & Research Inst, Bangalore.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2013-14/B