Alveolar Cleft
Conditions
Interventions
Group A:Bmac-loaded ß-TCP-CMC-Na scaffold prosthesis with 3D printing personalized shaping technology
Group B:Only BMAC was used to load on ß-TCP particles, without binding to CMC-Na gel
Group C:Repair was carried out with autologous iliac bone graft (gold standard).
Sponsors
Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
8 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1. Unilateral alveolar cleft confirmed by imaging examination. 2. No prior surgical repair for alveolar cleft. 3. No evidence of bone metabolic disorders. 4. No signs of infection in the surgical area. 5. The participant and/or their legal guardian agrees to participate in this trial and provides signedinformed consent. 6. Not currently participating in any other clinical trial.
Exclusion criteria
Exclusion criteria: 1. History of previous surgical repair for alveolar cleft. 2. History of previous maxillary surgery. 3. Presence of systemic infection or local infection at the surgical site. 4. History or related examination abnormalities of other bone metabolic diseases (e.g.,osteoporosis, osteomalacia)that may affect bone healing. 5. Preoperative evaluation indicating intolerance to general anesthesia or any other conditionrendering the patient unsuitable for surgery. 6. Inability to cooperate with preoperative assessments or required examinations during the trialperiod. 7. Currently participating in another clinical trial and has not yet reached the study endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osteogenesis rate (OR);Bone mineral density (BMD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of graft congruence with the preoperative 3D model; | — |
Countries
China
Contacts
Public ContactYongqian Wang
Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed