Reconstruction of alveolar clefts using cortical-shell grafts
Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)
This study tests a new way to help kids with unilateral alveolar clefts by using a special bone graft to support their jaw and help their teeth grow properly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 8 Years to 15 Years |
| Sex | All |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06585566 on ClinicalTrials.gov |
What this trial studies
This study evaluates a technique for secondary alveolar bone grafting (SABG) aimed at rehabilitating the maxilla in patients with unilateral alveolar clefts. The approach utilizes a retromolar cortical shell graft to stabilize the maxillary foundation, facilitating tooth eruption and orthodontic movements. The study focuses on patients aged 8 to 15 years who meet specific health criteria and excludes those with certain complications or previous reconstruction failures.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 15 years with unilateral maxillary alveolar clefts in good health.
Not a fit: Patients with bilateral alveolar clefts, cleft-associated syndromes, or systemic diseases affecting bone healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly improve the structural integrity of the maxilla and enhance dental outcomes for children with alveolar clefts.
How similar studies have performed: While this specific approach may be novel, similar techniques in alveolar cleft reconstruction have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft. 2. good oral hygiene and general good health Exclusion Criteria: 1. The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae. 2. Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing. 3. A history of previous failed alveolar cleft reconstruction.
Where this trial is running
Cairo and 1 other locations
- Amr Gibaly — Cairo, Egypt (Recruiting)
- Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information. — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Amr Hanafy Gibaly, PHD
- Email: amrgibaly@dent.bsu.edu.eg
- Phone: 01113336634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.