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

NCT ID: NCT05073757

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2025-02-25

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.

Conditions

Surgery; Orthognathic Surgery; Orthognathic Surgical Procedures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Orthognatic surgery

Orthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator.

Custom-made guides and plates

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Global D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Belgium; France

Other Identifiers

2001-S-CMF-SUR MESURE-R

Identifier Type: -

Identifier Source: org_study_id