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

Global D

Status

Completed

Conditions

Orthognathic Surgical Procedures

Surgery

Orthognathic Surgery

Treatments

Device: Custom-made guides and plates

Study type

Observational

Funder types

Industry

Identifiers

NCT05073757

2001-S-CMF-SUR MESURE-R

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Volunteers

No Healthy Volunteers

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.