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

NCT02048761 | Unknown Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2013-14/B
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Defects in Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Probing depth

  Baseline to 6 months

• Clinical attachment level

  Baseline to 6 months

• Modified sulcular bleeding index

  Baseline to 6 months

• Plaque index

  Baseline to 6 months

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo gel

1% Metformin

ACTIVE COMPARATOR

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

Drug: 1 % Metformin gel

Interventions

Placebo gel DRUG

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

Placebo Group

1 % Metformin gel DRUG

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

1% Metformin

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

Study Officials

• A R Pradeep, M.D.S.

  Govt Dental College & Research Inst, Bangalore.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 29, 2014
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

IN (1)