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

NCT05073757 | Completed

• 1 other identifier: 2001-S-CMF-SUR MESURE-R
• Study Type: observational
• Target: 56
• Locations: 2 countries
• Sites: 4

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

Keywords

orthognatic surgery; guided surgery; 3D printing; plate; screw; custom-made

Outcome Measures

Primary Outcomes (1)

• Orthognatic quality of life questionnaire

  To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients

  12 months post-operatively

Secondary Outcomes (2)

• Surgeon satisfaction on the implant's utilisation

  Immediately following surgery

• Security of the implants used for orthognathic surgery

  12 months

Study Arms (1)

Orthognatic surgery

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

Device: Custom-made guides and plates

Interventions

Custom-made guides and plates 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.

Orthognatic surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Orthognatic surgery male or female patients, adults or minors whose bone maturity is sufficient according to the judgment of the investigator.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global D: lead

Study Sites (4)

Cabinet chirurgie Maxillo-faciale

Tournai, 7500, Belgium

Location

Cabinet Orhognatic

Lyon, 69005, France

Location

Hôpital de la Loire

Saint-Etienne, 42100, France

Location

Hôpital Villefranche sur Sâone

Villefranche-sur-Saône, 69655, France

Location

MeSH Terms

Interventions

Bone Plates

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: October 11, 2021
• Study Start: September 17, 2021
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (3)