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