An observational study in Mandibular Hypoplasia and Relapse, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 10 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-18.
Sponsored by Universitair Ziekenhuis Brussel · Observational
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:
Bilateral sagittal split osteotomy (BSSO)of the mandible is a surgical procedure used to correct dentofacial discrepancies. Post-operative stability is of great concern for CMF (Cranio maxillo facial) surgeons as the goal is to achieve optimal functional outcomes, good aesthetic results and satisfaction of patients' concerns. Skeletal relapse is a known complication of mandibular lengthening surgery and is divided into two groups; short term or early relapse and long term or late relapse.
Short term relapse occurs within the first 6 to 8 weeks post-operatively and is due to intersegmental movement at the osteotomy site (osteotomy slippage) and osteosynthesis slippage. Late relapse is thought to be caused by progressive condylar resorption, a clinical entity affecting the temporomandibular joint.
The rationale to reconstruct the lateral cortical defect resulting from mandibular advancement with BSSO with a bone graft substitute lies in the prevention of an unaesthetic notching at the inferior border. The use of a self-hardening, space-occupying paste could add mechanical stability, thus increase 3D-stability at the osteotomy site and prevent early relapse.
The use of cone-beam computed tomography (CBCT) in the treatment planning and postoperative follow-up of orthognathic patients has provided the surgeons with a new three-dimensional imaging modality to evaluate the postoperative skeletal relapse and postoperative morphologic changes of the condyles. Skeletal relapse, as well as positional and dimensional changes of the condyles, can be quantified in three dimensions.
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Class II occlusion of non-syndromic origin, mandibular hypoplasia
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Exclusion Criteria:
patients receiving hydroset at osteotomy site
Procedure: Bilateral sagittal split osteotomy
patients not receiving hydroset at osteotomy site
Procedure: Bilateral sagittal split osteotomy
Bilateral sagittal split osteotomy of the mandible is a surgical procedure used to correct dentofacial discrepancies
early relapse by means of three dimensional color maps (CBCT)
evaluation at the osteotomy gap, the position of the condyles, rami and chin
Time frame: the first 6 months postoperatively
condylar resorption by means of three dimensional color maps (CBCT)
a three-dimensional volumetric analysis of the condylar head and the glenoid cavity
Time frame: the first 6 months postoperatively
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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