An observational study in Cleft Palate Children, sponsored by AZ Sint-Jan AV. Completed at 1 site in Belgium. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by AZ Sint-Jan AV · Observational
Objective: The investigators aim to compare the licensed Brainlab Iplan® software, considered the gold standard, to the 3D slicers and Blender freeware for the segmentation of the unilateral cleft defect, as well as the creation of individual 3D template for development of the bone graft.
Study design Retrospective, pilot study Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT). A single surgeon will run all the virtual planning steps with both the licensed software and the freeware. Timing of the four major steps will be measured with a digital chronometer (http://www.online-stopwatch.com/download-stopwatch/).
Ten children, 5 Belgian patients and 5 Hungarian patients, that already had a work-up and surgery for a unilateral cleft requiring a bone graft, will be planned. This based on the preoperative CBCT that is already present, by using both the licensed software and free software. The investigator will register patients' age, gender and cleft size and register the required time to complete the different planning steps, as well as list the number of actions to complete the planning, and the occurrence of software bugs. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon. All patients will be planned twice with an interval of two weeks in order to measure intra-observer reliability. Moreover, a second surgeon will also plan the 10 cases to measure inter-observer reliability.
Main study endpoints The investigators hypothesize that the licensed software is more user-friendly, ensuring a significant shorter overall treatment planning time to create a model for accurate bone transfer from the iliac crest to the jawbone.
131 studies on the registry are indexed under Cleft Palate; 36 are open to participants now.
This study's enrollment of 10 is below the median of 96 across 40 observational studies indexed under Cleft Palate.
Browse Cleft Palate studies →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.
Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT).
Exclusion Criteria:
Patients presenting at the division of maxillofacial surgery at the AZ Sint-Jan Brugge-Oostende av (Belgium) or the 1st department of pediatrics at the USemmelweis (Hungary) for bone graft surgery of the unilateral cleft receive a complete routine work-up, including a cone-beam CT (CBCT).
duration of total virtual planning time
measurement of total virtual planning time, with a digital chronometer
Time frame: preoperative
duration of segmentation of the cleft defect
measurement of segmentation of the cleft defect, with a digital chronometer
Time frame: preoperative
duration of creation of the individual 3D template
measurement of duration of creation of the individual 3D template, with a digital chronometer
Time frame: preoperative
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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AZ Sint-Jan AV