Metformin and Alveolar Cleft

April 11, 2026 updated by: Shaimaa Mohsen, Fayoum University

Does the Addition of Metformin to Autogenous Bone Graft Improve the Bone Quality After Alveolar Cleft Reconstruction? A Randomized Clinical Trial

  • Completed medical history will take for all patients. All patients' guardians were informed about the procedure, the possible postoperative complications, and requested to sign an informed consent that was translated into Arabic language.

  • Patients were randomly divided into two equal groups by means of sealed envelopes:

    • Group A ( study group) 18 patients who received a combination of illiac cancellous bone graft and 2ml of 1% metformin gel (20mg of metformin with 2% hydroxymethyl cellulose)
    • Group B (control group): 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose) Preparation of the Donor Site (Anterior Iliac Crest) and Harvesting of the Bone Graft
    • A standard incision will be done to expose the anterior iliac crest. The cancellous bone graft will be harvested using 8 mm diameter trephine bur (KLS Martin, city, Germany). The graft will be harvested by molt and surgical curettes. The wound was then closed in the usual manner.
    • For group A, the patients will receive iliac bone graft mixed with metformin gel and packed into the defect While in group B, the iliac bone graft will be mixed with placebo gel and packed into the defect.
    • The labial flap was then approximated to the palatal one and sutured over the cleft area beginning with a horizontal mattress suture followed by multiple interrupted sutures to completely cover the grafted area

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients with no syndromic unilateral alveolar cleft.
  • Patients' ages observed between 8 and 12 years.

Exclusion Criteria:

  • Syndromic cases will be excluded
  • Previous operated cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metformin group
Procedure: metformin group
- Group A: 18 patients who received a combination of illiac cancellous bone graft and 2ml of 1% metformin gel (20mg of metformin with 2% hydroxymethyl cellulose)
Active Comparator: placebo group
Procedure: placebo group
- Group B: 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone density
Time Frame: 6 months postoperative
by cone beam ct
6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 66

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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