Alveolar cleft
Conditions
Interventions
Iliac group:Implantation of autologous iliac cancellous bone
BMP-2 group:Implantation of low-dose sustained-release BMP-2 material
Sponsors
Affiliated Stomatology Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 7–12 years with non-syndromic unilateral alveolar cleft (with or without cleft palate). 2. Cleft type: linear cleft; no large fistula present at the incisive foramen on the palatal side. 3. Patients without intellectual disability and able to cooperate with treatment. 4. No evidence of malnutrition. 5. Intact mucosa within the cleft, with retained deciduous teeth or ectopically erupted permanent teeth in the cleft area. 6. The subject (or legal guardian) voluntarily signs the informed consent form prior to any study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Presence of a continuous bone bridge in the alveolar cleft region prior to surgery. 2. Presence of systemic diseases, including but not limited to bleeding disorders, skeletal disorders, or metabolic diseases. 3. History of alveolar cleft bone grafting. 4. Cleft width > 11 mm. 5. Presence of psychiatric disorders, severe psychological problems, or other conditions that impair oral hygiene maintenance or hinder cooperation. 6. Incomplete development of the permanent canine. 7. Patients requiring long-term high-dose corticosteroid therapy. 8. Presence of oral mucosal lesions (e.g., lichen planus, leukoplakia). 9. History of receiving full-dose radiotherapy or local radiotherapy to the head or neck. 10. Patients with immunodeficiency. 11. Poor compliance or inability to attend follow-up visits as scheduled. 12. Participation in another clinical trial involving drugs or medical devices within 30 days prior to Day 0 (surgery). 13. Use of anti-osteogenic or anticoagulant medications during the study period. 14. History of upper respiratory tract infection within the past two weeks. 15. Moderate rotation of the central incisor on the cleft side, leading to complete coverage of the cleft. 16. Vertical discrepancy between the two alveolar segments > one-half of the alveolar process height.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| volume of the graft;Height of the graft;density of the graft; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation time;Postoperative pain level;Discharge time; | — |
Countries
China
Contacts
Public ContactShufan Zhao
Affiliated Stomatology Hospital of Wenzhou Medical University
Outcome results
None listed