Metformin and Alveolar Cleft

NCT07536620 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 66
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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

Conditions

Alveolar Cleft

Outcome Measures

Primary Outcomes (1)

• bone density

  by cone beam ct

  6 months postoperative

Study Arms (2)

metformin group

EXPERIMENTAL

Procedure: metformin group

placebo group

ACTIVE COMPARATOR

Procedure: placebo group

Interventions

metformin group PROCEDURE

\- 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)

metformin group

placebo group PROCEDURE

\- Group B: 18 patients who received illiac cancellous bone graft and 2 ml placebo gel (2% hydroxymethyl cellulose

placebo group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Syndromic cases will be excluded
• Previous operated cases

Sponsors & Collaborators

• Fayoum University: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04