Clinical trial NCT02048761: Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis
Official title: Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intrabony Defects in Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Defect depth reduction
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Probing depth
timeFrame: Baseline to 6 months
measure: Clinical attachment level
timeFrame: Baseline to 6 months
measure: Modified sulcular bleeding index
timeFrame: Baseline to 6 months
measure: Plaque index
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
affiliation: Govt Dental College & Research Inst, Bangalore.
name: A R Pradeep, M.D.S.
role: PRINCIPAL_INVESTIGATOR
References: