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.
Study Type
OBSERVATIONAL
Enrollment
56
Patients will be included in the study and then followed clinically according to the routine care of orthognathic surgery with custom-made guides and plates. The only specific act of this study is the completion of an OQLQ quality of life questionnaire by patients preoperatively and between 8 to 12 months postoperatively.
Cabinet chirurgie Maxillo-faciale
Tournai, Belgium
Cabinet Orhognatic
Lyon, France
Hôpital de la Loire
Saint-Etienne, France
Hôpital Villefranche sur Sâone
Villefranche-sur-Saône, France
Orthognatic quality of life questionnaire
To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients
Time frame: 12 months post-operatively
Surgeon satisfaction on the implant's utilisation
Assessment by a satisfaction questionnaire, specially developed for the study, completed by the surgeon after the surgery. The surgeon evaluates each item using a likert scale (Highly Satisfied/ Satisfied/ Not very satisfied / Unsatisfied).
Time frame: Immediately following surgery
Security of the implants used for orthognathic surgery
Adverse events identification, assessment and follow-up.
Time frame: 12 months
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