Bilateral Alveolar Cleft Reconstruction Using Double Iliac Bone Blocks vs Particulate Grafting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iliac Corticocancellous Bone Block Graft, Autogenous Particulate Bone Graft.
- Who it may be relevant to
- Registry conditions: Alveolar Cleft. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Clinical Trial Comparing Double Iliac Corticocancellous Bone Blocks Versus Conventional Autogenous Particulate Bone Grafting for Bilateral Alveolar Cleft Reconstruction
Overview
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
Detailed description
Alveolar cleft reconstruction is a critical component in the comprehensive management of patients with cleft lip and palate, aiming to restore alveolar continuity, facilitate tooth eruption, and provide support for the nasal base. Autogenous bone grafting remains the gold standard for alveolar cleft repair, with the iliac crest being the most commonly used donor site due to its rich cancellous bone content.
Conventional particulate cancellous bone grafting has been widely used with predictable outcomes; however, it may be associated with graft resorption and reduced structural stability, particularly in bilateral alveolar cleft cases. Recently, the use of corticocancellous bone block grafts has been proposed to enhance graft stability, maintain volume, and improve overall outcomes.
This study aims to compare double iliac corticocancellous bone block grafts with conventional autogenous particulate bone grafting in the reconstruction of bilateral alveolar clefts. Patients diagnosed with bilateral alveolar clefts and meeting the inclusion criteria will be enrolled and allocated into two groups. One group will receive double iliac corticocancellous bone block grafts, while the other will undergo reconstruction using conventional particulate bone grafting techniques.
Clinical and radiographic evaluations will be performed to assess graft stability, bone volume, and postoperative complications. Follow-up assessments will be conducted at predefined intervals to evaluate the success and predictability of each technique. The findings of this study are expected to provide evidence regarding the most effective grafting approach for bilateral alveolar cleft reconstruction
Interventions
- Procedure Iliac Corticocancellous Bone Block Graft
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 - Procedure Autogenous Particulate Bone Graft
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.
Primary outcome measures
- bone volume [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- History of radiotherapy in the maxillofacial region.
- Contraindications to general anesthesia.
- Patients unwilling or unable to comply with follow-up.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Cairo University — Cairo
Identifiers
NCT: NCT07442279 · OMFS 3 3 8