Alveolar cleft
Conditions
Interventions
Group 1:Bone grafting in equal amount
Group 2:Bone graft amount of 1.25 times
Group 3:Bone graft amount of 1.5 times
Sponsors
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 8-12 years; 2. Children diagnosed with unilateral third-degree cleft lip or cleft lip and palate at birth, who have undergone cleft lip repair surgery before; 3. There is obvious alveolar ridge fracture in the preoperative diagnosis; the bone defect volume is in the range of 1-3cm3; 4. Have not performed alveolar ridge repair or gingival periosteonoplasty (GPP) before this alveolar ridge repair operation; 5. No orthodontic treatment before this alveolar ridge repair; 6. Normal communication skills; 7. The patient's guardian agrees to participate in this experiment and signs the informed consent; 8. Patients who meet the above conditions within 48 months of the start of the project.
Exclusion criteria
Exclusion criteria: 1. Combined with giant palatal fistula; 2. Patients with abnormal results of various admission routine examinations; 3. Patients with a history or related examination findings of other bone metabolic diseases that may affect bone healing (such as osteoporosis, osteomalacia, etc.); 4. Active period of infectious disease; 5. Patients with poor systemic nutritional status; 6. In addition to cleft lip and palate, there are other craniofacial deformities; 7. The bone defect is larger than 3cm3, and the continuous destruction requires a large amount of bone graft; 8. Patients with allergic constitution or allergic to disease treatment-related materials, reagents and drugs (ß-TCP, titanium nails); 9. Patients with alcohol or addictive drug dependence; 10. Those who are participating in other clinical trials and have not reached the end point.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osteogenesis rate; | — |
Countries
China
Contacts
Public ContactWang Yongqian
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed