Graft volume change in cleft alveolus grafting with cancellous iliac bone combined with PRF membrane and liquid PRF

Phase 3

Completed

• Conditions: Patients with unilateral alveolar cleft, aged 9- 16 years old, were enrolled in the study.; alveolar bone graft, cleft lip and palate, dimensional change, graft volume change, PRF

• Registration Number: TCTR20200605002
• Lead Sponsor: Faculty of Dentistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-12-30
• Study Start: 2020-06-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Patients undergoing alveolar bone graft surgery for repair unilateral cleft defects.
2.ASA class I, aged 9â€16 years

Exclusion Criteria

1. Patients who had bleeding disorders, bone and metabolic diseases.
2. Patients who will not available for 6-month follow up.
3. Patient who has alveolar cleft defect larger than 2 centimeters in diameter.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft volume change after alveolar bone grafting Post-operative 3, 6 months Cone beam CT and computer software.,Bone density Post-operative 3, 6 months Occlusal topographic X-ray,Graft quality Post-operative 3, 6 months Cone beam CT

Secondary Outcome Measures

Name	Time	Method
The dimensional change Post-operative 3, 6 months A series of cast-based measurement.,Post-operative pain , swelling and wound healing of recipient sites. Post op day 1-7 clinical evaluation