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Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Sponsor: Global D
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
56
Start Date
2021-09-17
Completion Date
2025-02-25
Last Updated
2026-10-06
Healthy Volunteers
No
Interventions
Custom-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.
Locations (4)
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