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Locally Delivered 1% Metformin Gel in Peri-implantitis

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
1% local metformin gel
Placebo
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Manual debridement and 1% metformin gel

    Manual debridement and placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Marginal bone loss
    Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.
    Peri-implant prpbing depth
    Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2017
    Last Updated
    October 12, 2017
    Sponsor
    King Saud University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03312582
    Brief Title
    Locally Delivered 1% Metformin Gel in Peri-implantitis
    Official Title
    Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 15, 2015 (Actual)
    Primary Completion Date
    August 14, 2016 (Actual)
    Study Completion Date
    July 24, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Saud University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-Implantitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual debridement and 1% metformin gel
    Arm Type
    Experimental
    Arm Title
    Manual debridement and placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    1% local metformin gel
    Intervention Description
    After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.
    Intervention Type
    Procedure
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.
    Primary Outcome Measure Information:
    Title
    Marginal bone loss
    Description
    Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.
    Time Frame
    6 months
    Title
    Peri-implant prpbing depth
    Description
    Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Locally Delivered 1% Metformin Gel in Peri-implantitis

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