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

Intrabony Defects in Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02048761
• Other study ID #: GDCRI/ACM/PG/PhD/2013-14/B
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 23, 2014
• Last updated: February 28, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Intrabony Defects in Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Probing depth	Probing depth is measured from baseline to 3 months and 6 months in both control and test group.	Baseline to 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No