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

Completed

• Conditions: Surgery; Orthognathic Surgery; Orthognathic Surgical Procedures

• Registration Number: NCT05073757
• Lead Sponsor: Global D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-04
• Study Start: 2021-09-17
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-11
• Primary Completion: 2025-02-25
• Study Completion: 2025-02-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Orthognatic quality of life questionnaire	12 months post-operatively	To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients

Secondary Outcome Measures

Name	Time	Method
Surgeon satisfaction on the implant's utilisation	Immediately following surgery	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).
Security of the implants used for orthognathic surgery	12 months	Adverse events identification, assessment and follow-up.

Trial Locations

Locations (4)

Hôpital de la Loire; 🇫🇷 Saint-Etienne, France

Cabinet chirurgie Maxillo-faciale; 🇧🇪 Tournai, Belgium

Cabinet Orhognatic; 🇫🇷 Lyon, France

Hôpital Villefranche sur Sâone; 🇫🇷 Villefranche sur Saône, France