Efficacy of resorbable collagen membrane on alveolar bone graft of cleft alveolus

Phase 4

• Conditions: nilateral cleft patient; Unilateral cleft patient; Alveolar bone graft; secondary alveolar bone graft; collagen membrane

• Registration Number: TCTR20200416001
• Lead Sponsor: The Princess Mother’s 100th Year Honoured Fund, Faculty of dentistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Study Completion: 2021-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Patients who is undergoing alveolar bone graft surgery to repair unilateral cleft defects
- Age 9-16 years old
- ASA class I

Exclusion Criteria

- Patient who has bleeding disorders, bone and metabolic diseases
- Not available for 6-month follow up
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone graft volume change 2 weeks, 3, 6 months post operative CBCT scan

Secondary Outcome Measures

Name	Time	Method
Bone density pre operative, 2 weeks, 1, 3, 6 months post operative Occlusal topographic film with step wedge technique,remaining bone graft height pre operative, 2 weeks, 1, 3, 6 months post operative Periapical paralelling film,Dimentional change 1, 3, 6 months post operative oral impression (Cast-based measurment),bone graft quality 2 weeks, 3, 6 months post operative CBCT scan