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COMPLETED
NCT05073757

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

Sponsor: Global D

View on ClinicalTrials.gov

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

DEVICE

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