Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

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.

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.