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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Orthognathic Surgery; Orthognathic Surgical Procedures
• Intervention / Treatment: Device: Custom-made guides and plates

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Belgium
  • Tournai, Belgium, 7500
    • Cabinet chirurgie Maxillo-faciale
• France
  • Lyon, France, 69005
    • Cabinet Orhognatic
  • Saint-Etienne, France, 42100
    • Hôpital de la Loire
  • Villefranche-sur-Saône, France, 69655
    • Hôpital Villefranche sur Sâone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Orthognatic surgery; Orthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon satisfaction on the implant's utilisation	Assessment by a satisfaction questionnaire, specially developed for the study, completed by the surgeon after the surgery. The surgeon evaluates each item using a likert scale (Highly Satisfied/ Satisfied/ Not very satisfied / Unsatisfied).	Immediately following surgery
Security of the implants used for orthognathic surgery	Adverse events identification, assessment and follow-up.	12 months

Collaborators and Investigators

• Sponsor: Global D
• Collaborators: Global D

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): February 25, 2025
• Study Completion (Actual): February 25, 2025

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: guided surgery; 3D printing; plate; custom-made; orthognatic surgery; screw
• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Maxillary Fractures; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Prostheses and Implants; Internal Fixators; Bone Plates
• Other Study ID Numbers: 2001-S-CMF-SUR MESURE-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No