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Completed

NCT Number: NCT03312582

Locally Delivered 1% Metformin Gel in Peri-implantitis

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% local metformin gel

Drug

After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.

Placebo

Procedure

Other names: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.

Primary outcomes

  1. Marginal bone loss

    Time frame: 6 months

    Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.

  2. Peri-implant prpbing depth

    Time frame: 6 months

    Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 17, 2017
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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