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

Government Dental College and Research Institute, Bangalore

Status and phase: Unknown; Phase 2

Conditions: Intrabony Defects in Chronic Periodontitis

Treatments: Drug: 1 % Metformin gel; Drug: Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02048761

GDCRI/ACM/PG/PhD/2013-14/B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula.

Treatment:

Drug: Placebo gel

1% Metformin

Active Comparator group

Description:

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

Treatment:

Drug: 1 % Metformin gel