CompletedNot Applicable

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

Belgium, France56 participantsStarted 2021-09-17

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Orthognatic quality of life questionnaire

Timeframe: 12 months post-operatively

Trial details

NCT IDNCT05073757

SponsorGlobal D

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-25

View on ClinicalTrials.gov More Surgery trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.