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Not yet recruiting Phase 2 NCT07536620

Metformin and Alveolar Cleft

Phase 2 – studying effectiveness and dosage
Conditions: Alveolar Cleft

Sponsor: Fayoum University

trial.available_in: БГ
Overview
* 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
Who can participate
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
Interventions
metformin group
PROCEDURE
placebo group
PROCEDURE
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
8 Years
Maximum age
12 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
30.05.2027
Registry ID
NCT07536620
Source
clinicaltrials.gov
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