Bone marrow mononuclear cells combined with beta-tricalcium phosphate granules for craniofacial bone defect repair: a randomized, traditional surgical controlled trial

Not Applicable

Recruiting

• Conditions: alveolar cleft

• Registration Number: ChiCTR1900020556
• Lead Sponsor: Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 8 to 12 years;<br>2. Diagnosed as unilateral cleft lip or Cleft lip and palate combined by alveolar cleft. The Cleft lip and palate have been repaired;<br>3. No alveolar cleft repair or Gingival periosteoplasty was performed before;<br>4. No orthodontic treatment was performed before;<br>5. The patient's guardian agreed to participate in the experiment and signed the informed consent form.

Exclusion Criteria

1. Bilateral cleft lip or cleft lip and palate;<br>2. Combined with palatal fistula which requiring surgical repair;<br>3. Definitely diagnosed as well-known syndrome or combined with other craniofacial deformities besides cleft lip and palate;<br>4. Orthodontic treatment is demanded before bone grafting or conventional single treatment is insufficient for the repair of alveolar bone defect;<br>5. Intolerance to general anesthesia evaluated by preoperative examination and assessment or not suitable for surgery by other causes;<br>6. Poorly compliance to preoperative evaluation or examinations during the whole experimental period;<br>7. Patients with a history or examnation of bone metabolic disorders that may affect bone healing process (Such as osteoporosis, osteomalacia, etc.);<br>8. Allergic constitution, or with clear allergic history of related materials, reagents and drugs;<br>9. Alcohol or drug addicts;<br>10. Those who are participating in other clinical trials and have not reached the end point.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone formation ratio;

Secondary Outcome Measures

Name	Time	Method
Chelsea scale;Luwei Liu and Lian Ma’s scale;Pain intensity rating scales;Total operative time and total blood loss;