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

NCT05073757 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2026-01-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Global D

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2025-02-25
Completion
2025-02-25

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05073757 on ClinicalTrials.gov