Locally Delivered 1% Metformin Gel in Peri-implantitis

K

King Saud University

Status and phase

Completed
Phase 4

Conditions

Peri-Implantitis

Treatments

Drug: 1% local metformin gel
Procedure: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03312582
FR-17-75

Details and patient eligibility

About

This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.

Full description

Metformin is an oral hypoglycemic drug categorized under biguanide and are considered the most efficient agents widely used in the treatment of type 2 diabetes mellitus.The general clinical benefits observed in therapy with MF seem to be greater than expected. They induce osteoblast cells to promote early bone formation through AMP kinase (AMPK) activity. Moreover, in a recent in vitro study, MF facilitated in the proliferation of MG63 osteoblast like cells. Thus, their action in stimulating bone formation has justified their use in the treatment of perimplantitis.

Enrollment

46 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Type 2 diabetes mellitus patients.
  • Patients with peri-implantitis

Exclusion criteria

  • History of any other systemic diseases
  • Cigarette smokers
  • Smokeless tobacco users
  • Patients who underwent scaling in the last 1 year
  • Patients who took antibiotics in tje past 6 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

46 participants in 2 patient groups, including a placebo group

Manual debridement and 1% metformin gel
Experimental group
Treatment:
Drug: 1% local metformin gel
Manual debridement and placebo
Placebo Comparator group
Treatment:
Procedure: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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