Alveolar cleft
Conditions
Interventions
6-8 years old bone grafting group:Equal amounts of autologous iliac bone grafting in patients aged 6-8 years
9-11 years old bone grafting group:Equal amounts of autologous iliac bone grafting in patients aged 9-11 years
Group 1:Extract 10ml of bone marrow blood per 1cm3, centrifuge at 2000rpm for 15 minutes to extract nucleated cells and transplant with ß-TCP to repair alveolar crista cleft defect
Group 2:Extract 20ml of bone marrow blood per 1cm3, centrifuge at 2000rpm for 15 minutes, and then centrifuge the nucleated cells twice (centrifuge at 1000rpm for 5 minutes) to extract nucleated cells
Sponsors
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
6 Years to 25 Years
Inclusion criteria
Inclusion criteria: Part1:1.6-11 years old; 2. Children with unilateral third-degree cleft lip or cleft lip and palate diagnosed at birth, who have previously undergone cleft lip repair surgery; 3. Obvious alveolar ridge fissures in preoperative diagnosis; 4. Alveolar cleft repair and gingival periotoplasty (GPP) have not been performed before this alveolar cleft repair; 5. No orthodontic treatment has been performed before this alveolar cleft repair surgery; 6. Normal communication ability; 7. The admission examination is basically normal; 8. The patient's guardian agrees to participate in this experiment and signs the informed consent form; 9. Not participating in other clinical trials at the same time; 10. Patients who meet the above conditions within 24 months of the start of the project. Part 2:(1) congenital unilateral cleft lip and palate alveolar cleft; (2) The condition is stable for more than 1 year; (3) All preoperative examinations are normal; (4) 8-25 years old; (5) Gender is not limited; (6) Those who agree to sign the informed consent form of the experiment; (7) At the same time, it did not participate in other clinical trials.
Exclusion criteria
Exclusion criteria: Part1:1. Combined with giant palatal fistula; 2. Patients with abnormal results of various routine examinations on admission; 3. Patients with a history of other bone metabolic diseases that may affect bone healing or related examination findings (such as osteoporosis, osteomalacia, etc.); 4. Active period of infectious diseases; 5. Patients with poor systemic nutritional status; 6. In addition to cleft lip and palate, there are other craniofacial deformities; 7. Those who are participating in other clinical trials and have not reached the end point; 8. Patients with allergies or allergies to materials, reagents and drugs related to disease treatment (ß-TCP, titanium nails). Part2:(1) Patients with abnormal results of various routine examinations on admission; (2) Those who need preoperative orthodontic treatment, or have the intention of orthodontic treatment within 1 year after surgery; (3) Syndromic alveolar crest (such as forebrain fissure, etc.); (4) Patients with palatal fistula or who have undergone tongue flap treatment; (5) Patients with teeth in the bone grafting area who need to be extracted may affect postoperative osteogenesis; (6) After radiotherapy or multiple surgeries or trauma, there is extensive scarring in the affected area and poor blood supply; (7) Patients who have recently received BMP growth factor and other bone growth-promoting factors; (8) Patients with local foci of infection in the whole body or surgical area; (9) Patients with allergies or allergies to materials, reagents and drugs related to disease treatment (ß-TCP, titanium nails); (10) Those who are participating in other clinical trials and have not reached the endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osteogenesis rate;Bone graft volume;Osteogenic volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Craniofacial Bone Defect Repair Score; | — |
Countries
China
Contacts
Public ContactWang Yongqian
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed