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.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Drug: 1% local metformin gel; Procedure: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Placebo; Other Names: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone loss	Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.	6 months
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

Collaborators and Investigators

• Sponsor: King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2015
• Primary Completion (Actual): August 14, 2016
• Study Completion (Actual): July 24, 2017

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: FR-17-75

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No