Alveolar Cleft Reconstruction With Cortical-Shells (NCT06585566) | Clinical Trial Compass
RecruitingNot Applicable
Alveolar Cleft Reconstruction With Cortical-Shells
Egypt7 participantsStarted 2024-10-04
Plain-language summary
The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.
The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.
Who can participate
Age range
8 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
. good oral hygiene and general good health
Exclusion criteria
. The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
. Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
. A history of previous failed alveolar cleft reconstruction.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is reconstructing the alveolar cleft using something called 'cortical-shells' — can you explain what that technique involves and how it differs from the standard bone graft procedure my child might otherwise receive?
2Since this trial is listed as Phase 'NA,' what does that mean for how much is already known about the safety and effectiveness of this cortical-shell approach in children with alveolar clefts?
3The trial is measuring horizontal bone width as its main outcome — what does that tell us about whether the reconstruction actually worked, and are there other things like tooth eruption or facial development that it won't be tracking?
4Given that this trial is currently recruiting, how does the timing fit with my child's dental and facial development, and would waiting to join versus starting standard treatment now make a meaningful difference?
5If we decide not to enroll in this trial, what is the current standard of care for alveolar cleft reconstruction, and how do the expected outcomes compare to what this study is trying to achieve?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.