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Locally Delivered 1% Metformin Gel in Peri-implantitis

NCT ID: NCT03312582

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-15

Study Completion Date

2017-07-24

Brief Summary

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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

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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.

Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Manual debridement and 1% metformin gel

Group Type EXPERIMENTAL

1% local metformin gel

Intervention Type DRUG

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

Manual debridement and placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

Interventions

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1% local metformin gel

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

Intervention Type DRUG

Placebo

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Zohaib Akram

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FR-17-75

Identifier Type: -

Identifier Source: org_study_id