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Metformin and Alveolar Cleft

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07536620
Enrollment
36
Registered
2026-04-17
Start date
2026-05-01
Completion date
2027-05-30
Last updated
2026-04-17

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

Conditions

Alveolar Cleft

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

Interventions

\- 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)

PROCEDUREplacebo group

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

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
bone density6 months postoperativeby cone beam ct

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026