Locally Delivered 1% Metformin Gel in Peri-implantitis
This study has been completed.
King Saud University
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Information provided by (Responsible Party):
Zohaib Akram, King Saud University
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.
|Peri-Implantitis||Drug: 1% local metformin gel Procedure: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Further study details as provided by Zohaib Akram, King Saud University:
Primary Outcome Measures:
- 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.
|Actual Study Start Date:||March 15, 2015|
|Study Completion Date:||July 24, 2017|
|Primary Completion Date:||August 14, 2016 (Final data collection date for primary outcome measure)|
|Experimental: Manual debridement and 1% metformin gel||
Drug: 1% local metformin gel
After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.
|Placebo Comparator: Manual debridement and placebo||
Other Name: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.
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.
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