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Locally Delivered 1% Metformin Gel in Peri-implantitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03312582
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zohaib Akram, King Saud University
October 12, 2017
October 17, 2017
October 17, 2017
March 15, 2015
August 14, 2016   (Final data collection date for primary outcome measure)
  • Marginal bone loss [ Time Frame: 6 months ]
    Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.
  • 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.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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Locally Delivered 1% Metformin Gel in Peri-implantitis
Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peri-Implantitis
  • Drug: 1% local metformin gel
    After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.
  • Procedure: Placebo
    Other Name: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.
  • Experimental: Manual debridement and 1% metformin gel
    Intervention: Drug: 1% local metformin gel
  • Placebo Comparator: Manual debridement and placebo
    Intervention: Procedure: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 24, 2017
August 14, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03312582
FR-17-75
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Zohaib Akram, King Saud University
King Saud University
Not Provided
Not Provided
King Saud University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP