An observational study in Jaw Abnormalities, sponsored by AZ Sint-Jan AV. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by AZ Sint-Jan AV · Observational
Orthognathic surgery or corrective jaw surgery is indicated for conditions of the jaw and face that are related to structure or growth malfunctioning, orthodontic problems, or co-morbidities associated with skeletal disfigurement.
Imaging is crucial in the assessment and treatment planning of orthognathic surgery patients. Until recently, two-dimensional (2D) imaging, through cephalometry, was standard practice. However, it showed several limitations. The introduction of the cone-beam computed tomography (CBCT) enabling three-dimensional (3D) imaging has caused a paradigm shift. Though widespread implementation in routine practice is not yet present. Our department is one of the pioneers in the world of 3D virtual treatment planning for orthognathic surgery. The "triple CBCT scan procedure" has been developed in-house and implemented already in 2009.
The investigators aim to develop a prospective database registering 3D treatment planning data of all consecutive patients eligible for orthognathic surgery, performed by Prof. Swennen. Patient demographics, detailed virtual 3D treatment planning parameters and orthognathic surgery data are being collected during consecutive visits within the framework of routine practice.
Development of a database registering 3D virtual treatment planning data of orthognathic surgery, will provide more information about potential patient, virtual planning and surgical factors influencing postoperative accuracy of jaw correction, long-term stability of the jawbone, long-term condylar resorption, or soft tissue response. In general, it could provide answers on research questions that have been examined in prior studies on 2D-imaging, but can now be re-examined in case of 3D-imaging. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.
AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consenting patients, eligible for orthognathic surgery, performed at the General Hospital Saint-John Bruges, from July 1st 2010 onwards.
Exclusion Criteria:
Accuracy of hard tissue, soft tissue and teeth transfer after 3D planning, as measured with CBCT
Time frame: within 12 months postoperative
Prevalence of patients with an indication for orthognathic surgery
Time frame: 6 years
Accuracy of bone transfer, as measured through superimposition of 3D planning CBCT and postoperative CBCT
Time frame: 4 weeks postoperative
Long-term stability, through clinical evaluation and superimposition of 3D planning CBCT and postoperative CBCT
Time frame: 6 months postoperative
number of patients with condylar resorption
Time frame: until 12 months postoperative
number of patients with temporomandibular joint complications
Time frame: until 12 months postoperative
sample size calculation for future large prospective trials, based on pilot data
Time frame: 6 years
Plan to share: No
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Jaw Abnormalities
AZ Sint-Jan AV