alveolar cleft
Conditions
Interventions
Experiment Group:Bone marrow mononuclear cells combined with beta-tricalcium phosphate granules
Control Group:Autologous iliac crest bone graft
Sponsors
Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 8 to 12 years; 2. Diagnosed as unilateral cleft lip or Cleft lip and palate combined by alveolar cleft. The Cleft lip and palate have been repaired; 3. No alveolar cleft repair or Gingival periosteoplasty was performed before; 4. No orthodontic treatment was performed before; 5. The patient's guardian agreed to participate in the experiment and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Bilateral cleft lip or cleft lip and palate; 2. Combined with palatal fistula which requiring surgical repair; 3. Definitely diagnosed as well-known syndrome or combined with other craniofacial deformities besides cleft lip and palate; 4. Orthodontic treatment is demanded before bone grafting or conventional single treatment is insufficient for the repair of alveolar bone defect; 5. Intolerance to general anesthesia evaluated by preoperative examination and assessment or not suitable for surgery by other causes; 6. Poorly compliance to preoperative evaluation or examinations during the whole experimental period; 7. Patients with a history or examnation of bone metabolic disorders that may affect bone healing process (Such as osteoporosis, osteomalacia, etc.); 8. Allergic constitution, or with clear allergic history of related materials, reagents and drugs; 9. Alcohol or drug addicts; 10. Those who are participating in other clinical trials and have not reached the end point.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone formation ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chelsea scale;Luwei Liu and Lian Ma’s scale;Pain intensity rating scales;Total operative time and total blood loss; | — |
Countries
China
Contacts
Public ContactRan Xiao
Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed