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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03312582
Enrollment
46
Registered
2017-10-17
Start date
2015-03-15
Completion date
2017-07-24
Last updated
2017-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

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.

Interventions

DRUG1% local metformin gel

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

PROCEDUREPlacebo

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Marginal bone loss6 monthsMarginal bone loss will be assessed on digital radiographs on calibrated computer screen.
Peri-implant prpbing depth6 monthsWill be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026