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A prospective randomized controlled clinical trial of Bio-Oss bone powder or autologous iliac bone in the repair of congenital unilateral alveolar cleft

A prospective randomized controlled clinical trial of Bio-Oss bone powder or autologous iliac bone in the repair of congenital unilateral alveolar cleft

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051199
Enrollment
Unknown
Registered
2021-09-15
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-05-23

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

Conditions

alveolar cleft

Interventions

Group A:Iliac cancellous bone transplantation
Group B:Bio-Oss bone powder

Sponsors

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Select clinical children in the age range of 7-16 years, regardless of gender; 2. Those who have been clinically diagnosed as unilateral congenital alveolar cleft, cleft lip and (or) cleft palate who have undergone repair surgery; 3. Good compliance, willing to sign the consent form and able to conduct follow-up observations as required; 4. Those who need and can tolerate alveolar fracture repair surgery.

Exclusion criteria

Exclusion criteria: 1. Those who have participated in other clinical trials within 3 months; 2. Those with uncontrolled endocrine and metabolic diseases, blood system diseases and cardiovascular diseases; 3. Patients with systemic immune diseases; 4. Neurological diseases, such as epilepsy patients; 5. Pathological mucosal lesions; 6. The latter received radiotherapy on the head and neck; 7. Uncontrolled periodontal disease or extremely poor oral hygiene; 8. Long-term use of special drugs such as hormones, anticoagulants, etc.; 9. Other circumstances that the investigator considers unsuitable for the trial.

Design outcomes

Primary

MeasureTime frame
Bone volume change (stability);Detumescence time;satisfaction;

Secondary

MeasureTime frame
pain score;inflammation of soft tissue;

Countries

China

Contacts

Public ContactZou Duohong

Shanghai Ninth People's Hospital

zdhyy@ahmu.edu.cn+86 13601645549

Outcome results

None listed

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