Relapse Clinical Trial
Official title:
Evaluation of Early Relapse After Mandibular Lengthening Surgery With or Without the Use of a Bone Graft Substitute at the Osteotomy Site.
The goal of this study is to evaluate whether the use of a bone graft substitute at the
osteotomy site will result in better stability and diminish early relapse after mandibular
lengthening surgery.
The study focuses on the evaluation of the following hypothesis:
The use of bone graft substitute at the osteotomy site has an influence on:
- The 3-dimensional stability of the osteotomy site
- Early relapse based in the plasticity of the site
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Class II occlusion of non-syndromic origin, mandibular hypoplasia - Availability of pre- and postoperative CBCT scans of sufficient quality - Age: >10years Exclusion Criteria: - Previous orthognathic surgical treatment - Simultaneously performed genioplasty - Plate osteosynthesis - Buccal plate fracture during surgery |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Jette | Vlaams Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | early relapse by means of three dimensional color maps (CBCT) | evaluation at the osteotomy gap, the position of the condyles, rami and chin | the first 6 months postoperatively | |
Secondary | condylar resorption by means of three dimensional color maps (CBCT) | a three-dimensional volumetric analysis of the condylar head and the glenoid cavity | the first 6 months postoperatively |
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