Metformin and Alveolar Cleft

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-12
SponsorFayoum University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with no syndromic unilateral alveolar cleft.

Patients' ages observed between 8 and 12 years.

Disqualifiers

Syndromic cases will be excluded

Previous operated cases

Trial design

Design model

Parallel

Treatments tested in this trial

  • metformin group

    Procedure/Surgery

    \- 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)

  • placebo group

    Procedure/Surgery

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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: metformin groupExperimental treatment 1 intervention
Group B: placebo groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

bone density

by cone beam ct

Time frame
6 months postoperative

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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