Locally Delivered 1% Metformin Gel in Peri-implantitis

Peri-Implantitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312582
• Other study ID #: FR-17-75
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2017
• Last updated: October 12, 2017
• Start date: March 15, 2015
• Est. completion date: July 24, 2017

Study information

• Verified date: October 2017
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 24, 2017
• Est. primary completion date: August 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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

Procedure:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone loss	Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.	6 months
Primary	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.	6 months