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ID
Source
Brief title
Health condition
Orthognathic surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy of the execution of the genioplasty
Secondary outcome
Surgery time
Background summary
In this study, we investigate whether or not the accuracy of genioplastic surgery improves with the use of patient specific cutting/positioning guides.
The positional changes of the chin segment are nowadays planned using 3D computer technique. Compared to the older 2D planning the complexity of the planning has increased dramatically. To transfer the 3D computer plan to the patient during the surgery patient specific guides are frequently used. It is not known if these guides actually improve the accuracy.
Study objective
Application of patient-specific guides will improve the accuracy of the execution of the genioplasty
Study design
Before surgery: preoperative (CB)CT scan
Surgery: surgery time
After surgery: postoperative (CB)CT scan
Intervention
Execution of genioplastic surgery with patient-specific cutting and repositioning guides versus conventional method (without guides)
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Older than 18 years
• Genioplasty indicated in 3D preoperative planning.
Exclusion criteria
A potential subject will be excluded from participation in this study when the surgery is indicated for any of the following conditions:
• Congenital disorders (e.g. craniofacial microsomia)
• Obstructive Sleep Apnea Syndrome (OSAS)
• Transgender surgery
• Previous orthognathic surgery
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8332 |
| CCMO | NL72676.018.20 |
| OMON | NL-OMON55324 |