Repairing alveolar clefts in children using new bone graft materials
Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate
This study is testing a new type of bone material to see if it works better than traditional bone grafts for closing clefts in the mouths of children aged 8 to 12.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 4 sites (Amsterdam and 3 other locations) |
| Trial ID | NCT05331456 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using osteoinductive biphasic calcium phosphate putty for alveolar cleft closure compared to traditional autologous bone grafts harvested from the chin. Conducted as a multicenter stepped wedge randomized trial, it involves children aged 8 to 12 years with unilateral cleft lip and palate. The primary outcome is the measurement of residual bone volume one year post-surgery, while secondary outcomes include postoperative pain and tooth eruption in the reconstructed area. The aim is to reduce donor site morbidity and postoperative discomfort associated with conventional grafting methods.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 12 years with unilateral alveolar clefts requiring early secondary closure.
Not a fit: Patients with cleft lip and palate in a syndromic context may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could minimize postoperative pain and eliminate the need for harvesting bone from the patient, leading to better recovery experiences.
How similar studies have performed: Other studies have shown promise in using calcium phosphate ceramics for bone grafting, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * unilateral alveolar cleft, early secondary alveolar cleft closure Exclusion Criteria: * cleft lip and palate in a syndromic context
Where this trial is running
Amsterdam and 3 other locations
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- UMC Groningen — Groningen, Netherlands (Recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nard Janssen, MD, DDS, PhD — UMC Utrecht
- Study coordinator: Nard Janssen, MD, DDS, PhD
- Email: n.g.janssen-2@umcutrecht.nl
- Phone: 0887574560
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.