Orthognathic Surgery, Orthognathic Surgical Procedures, Surgery
Conditions
Keywords
orthognatic surgery, guided surgery, 3D printing, plate, screw, custom-made
Brief 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.
Interventions
DEVICECustom-made guides and plates
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.
Sponsors
Global D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orthognatic quality of life questionnaire | 12 months post-operatively | To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon satisfaction on the implant's utilisation | Immediately following surgery | 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). |
| Security of the implants used for orthognathic surgery | 12 months | Adverse events identification, assessment and follow-up. |
Countries
Belgium, France
Outcome results
None listed