Evaluating personalized implants for jaw surgery
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
Global D · NCT05073757
This study is testing whether custom-made implants for jaw surgery can improve results and quality of life for patients having their first surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Sex | All |
| Sponsor | Global D (industry) |
| Locations | 3 sites (Tournai and 2 other locations) |
| Trial ID | NCT05073757 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance and safety of personalized implants, including guides and plates, used in orthognathic surgery. It aims to gather clinical data on the effectiveness of these custom devices developed by SLS France. The study will involve patients undergoing their first orthognathic surgery with these personalized tools, assessing outcomes and patient quality of life. The approach leverages advancements in 3D printing technology to enhance surgical precision.
Who should consider this trial
Good fit: Ideal candidates include adults or minors who have reached bone maturity and are undergoing their first orthognathic surgery with personalized guides and plates.
Not a fit: Patients with allergies to the implant materials, significant physical or mental disabilities, or those with congenital craniofacial malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction in orthognathic procedures.
How similar studies have performed: While the use of personalized implants in surgery is gaining traction, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tournai and 2 other locations
- Cabinet chirurgie Maxillo-faciale — Tournai, Belgium (ACTIVE_NOT_RECRUITING)
- Cabinet Orhognatic — Lyon, France (RECRUITING)
- Hôpital Villefranche sur Sâone — Villefranche sur Saône, France (RECRUITING)
Study contacts
- Study coordinator: Victor Doligez
- Email: v.doligez@globald.com
- Phone: +33 0624173902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgery, Orthognathic Surgery, Orthognathic Surgical Procedures, orthognatic surgery, guided surgery, 3D printing, plate, screw