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

Recruiting

• Conditions: Surgery; Orthognathic Surgery; Orthognathic Surgical Procedures
• Interventions: Device: Personalized guides and plates

• 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 personalized implants (personalized 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
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• 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 personalized 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

Arm && Interventions

Group	Intervention	Description
Orthognatic surgery	Personalized guides and plates	Orthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator.

Primary Outcome Measures

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

Trial Locations

Locations (3)

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

Cabinet chirurgie Maxillo-faciale; 🇧🇪 Tournai, Belgium

Cabinet Orhognatic; 🇫🇷 Lyon, France