NCT05073757

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Global D · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery
• Orthognathic Surgery
• Orthognathic Surgical Procedures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-17
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2021-10-11
• Last updated: 2026-01-21

Locations

4 sites across 2 countries: Belgium, France