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

Launched by GLOBAL D · Oct 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well personalized implants—specifically customized guides and plates—work in a type of surgery called orthognathic surgery, which helps correct bone and jaw issues. The researchers want to gather important information about the safety and effectiveness of these personalized devices made by SLS France, especially as technology like 3D printing becomes more common in surgeries.

To participate in this study, patients need to be either adults or minors who have completed their growth, and they should be preparing for their first orthognathic surgery using these personalized implants. They must have already received orthodontic treatment (like braces) and be able to understand and respond to questions about their quality of life. However, people with certain conditions, such as allergies to the implant materials or significant health issues, cannot participate. Those who join the study will help researchers learn more about personalized treatment options in cranio-maxillofacial surgery, and their involvement will contribute to improving care for future patients.

Gender

ALL

Eligibility criteria

• 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.