cleft lip and palate
Conditions
Interventions
Experimental group1:Simultaneous repair of alveolar cleft with autogenous iliac bone graft
Experimental group2:Simultaneous repair of alveolar cleft with TCP
Control group:Repair of secondary cleft lip deformity
Sponsors
Plastic Surgery Hospital of Peking Union Medical College
Eligibility
Sex/Gender
All
Age
16 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16 to 25 years; 2. Patients with unilateral cleft lip or cleft lip and palate diagnosed at birth, who have undergone cleft lip repair surgery before; 3. There is obvious alveolar ridge fracture in preoperative diagnosis; the volume of bone defect is in the range of 1-3cm^3; 4. No alveolar ridge repair or gingival periosteoplasty (GPP) was performed before this alveolar ridge repair; 5. No orthodontic treatment before this alveolar ridge repair surgery; 6. Normal communication skills; 7. The admission examination is basically normal; 8. Patients or guardians agree to participate in this experiment and sign the informed consent; 9. Patients who meet the above conditions within 48 months of the start of the project.
Exclusion criteria
Exclusion criteria: 1. Combined giant palatal fistula; 2. Those with severe impairment of vital organ functions such as heart, lung, brain, kidney, and hematopoietic function; 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. The bone defect is larger than 3cm^3, and the continuous damage requires a large amount of transplanted bone for the bone defect; 7. Patients with allergic constitution or allergic to disease treatment-related materials, reagents and drugs (ß-TCP, titanium nails); 8. Patients with alcohol or addictive drug dependence; 9. Those who are participating in other clinical trials and have not reached the end point.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osteogenesis rate;Lip and nose symmetry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Infection rate; | — |
Countries
China
Contacts
Public ContactWang Yongqian
Plastic Surgery Hospital of Peking Union Medical College
Outcome results
None listed