Trial record 1 of 256763 for: ALL

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Locally Delivered 1% Metformin Gel in Peri-implantitis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT03312582

First Posted: October 17, 2017

Last Update Posted: October 17, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Zohaib Akram, King Saud University

Tracking Information

First Submitted Date ^ICMJE

October 12, 2017

First Posted Date ^ICMJE

October 17, 2017

Last Update Posted Date

October 17, 2017

Actual Start Date ^ICMJE

March 15, 2015

Primary Completion Date

August 14, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Locally Delivered 1% Metformin Gel in Peri-implantitis

Official Title ^ICMJE

Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Peri-Implantitis

Intervention ^ICMJE

Drug: 1% local metformin gel
After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.
Procedure: Placebo
Other Name: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.

Study Arms

Experimental: Manual debridement and 1% metformin gel
Intervention: Drug: 1% local metformin gel
Placebo Comparator: Manual debridement and placebo
Intervention: Procedure: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 24, 2017

Primary Completion Date

August 14, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03312582

Other Study ID Numbers ^ICMJE

FR-17-75

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Zohaib Akram, King Saud University

Study Sponsor ^ICMJE

King Saud University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

King Saud University

Verification Date

October 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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