Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxil… (NCT05073757) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Belgium, France56 participantsStarted 2021-09-17
Plain-language summary
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
Our project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.
Who can participate
SexALL
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Inclusion Criteria:
* Male or female patient, adult or minor having reached bone maturity according to the judgment of the investigator,
* Patient having first orthognathic surgery with SLS France custom-made guides and plates,
* Patient who received orthodontic treatment prior to orthognathic surgery,
* Patient able to read, understand and answer the study quality of life questionnaire,
* Patient (and legal representative if a minor) who is not opposed to his participation in the study or to the processing of his data.
* Patient affiliated to a social insurance
Exclusion Criteria:
* Patient allergic to one of the compounds of the plates and / or guides,
* Patient with physical or mental disability making it impossible to follow up in the study,
* Patient with significant expansion
* Patient with a congenital craniofacial malformation
* Patient with acute or chronic local or systemic infection,
* Person placed under legal protection,
* Pregnant or breastfeeding women.