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A prospective randomized controlled study of bicortical bone graft in the repair of alveolar cleft

A prospective randomized controlled study of bicortical bone graft in the repair of alveolar cleft

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111832
Enrollment
Unknown
Registered
2025-11-06
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar cleft

Interventions

Free iliac cancellous bone transplantation group:Free iliac cancellous bone transplantation
Lliac cancellous bone combined with bicortical bone suture fixation transplantation group:Lliac cancellous bone combined with bicortical bone suture fixation transplantation

Sponsors

Plastic Surgery Hospotal, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Born with unilateral cleft lip or cleft lip and palate, and has completed cleft lip and cleft palate repair surgery, there is alveolar cleft at present; 2. Age >=6 years old, regardless of sex; 3. Preoperative examination was normal; 4. Normal ability to communicate; 5. Patients or his guardian signed informed consent of this clinical study.

Exclusion criteria

Exclusion criteria: 1. Combined with other craniofacial deformities; 2. There are teeth in the bone graft area that need to be extracted or infected; 3. Preoperative examination was abnormal, may affect the operation; 4. Mental or hearing impairment affects experimental communication and mental illness can not cooperate with doctors; 5. Active stage of infectious disease. 6. Those who have participated or are participating in relevant clinical trials in the past.

Design outcomes

Primary

MeasureTime frame
Osteogenic rate;

Secondary

MeasureTime frame
Three-dimensional grading standard of alveolar cleft bone;Bergland evaluation system;

Countries

China

Contacts

Public ContactSong Tao

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

gxstst@126.com+86 135 8153 7740

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026