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
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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