Bilateral Alveolar Cleft Reconstruction Using Double Iliac Bone Blocks vs Particulate Grafting

ConditionAlveolar Cleft

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorCairo University

About this trial

This study aims to compare the clinical outcomes of bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts versus conventional autogenous particulate bone grafting. The study will evaluate graft stability, bone volume, and postoperative complications in patients with bilateral alveolar clefts. Participants will be allocated into two groups, each receiving one of the two grafting techniques. Clinical and radiographic assessments will be performed during follow-up to determine the effectiveness and predictability of each method

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients diagnosed with bilateral alveolar cleft requiring secondary alveolar bone graft.

Medically fit for surgery under general anesthesia.

Adequate soft tissue coverage at the cleft site.

Patients (or guardians) able to provide informed consent.

Disqualifiers

Unilateral alveolar cleft.

Presence of systemic diseases affecting bone healing (e.g., Diabetes Mellitus uncontrolled, osteoporosis).

Syndromic cleft patients.

Poor oral hygiene or active infection at the surgical site.

Trial design

Design model

Parallel

Treatments tested in this trial

Iliac Corticocancellous Bone Block Graft
Procedure/Surgery
participants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone blocks harvested from the iliac crest. The grafts will be secured to premaxilla by micro screws to restore alveolar continuity, facilitate tooth eruption, and improve bone volume
Autogenous Particulate Bone Graft
Procedure/Surgery
participants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest. The graft material will be packed into the alveolar defect to restore bone continuity and support future tooth eruption.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Double Iliac Corticocancellous Bone Block GraftExperimental treatment 1 intervention

Group B: Conventional Autogenous Particulate Bone GraftActive comparator 1 intervention

Trial outcomes

Primary outcomes

bone volume

Measurement of alveolar bone volume using radiographic imaging (CBCT) to compare bone maintenance between the two techniques

Time frame

6 months

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

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