Validation of a new digital intraoral protection for athletes
Official title: Validation of a Generic Procedure for the Fabrication of a Custom-made Intra-oral Protection Using an Inter-arch Piece
Run by University Hospital, Bordeaux · NCT05866835 · Data updated 2026-11-12
This study is testing a new type of custom mouthguard made with digital technology to see if it can help rugby players breathe better and feel more comfortable while playing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 35 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 3 sites (Bordeaux and 2 other locations) |
| Status | Recruiting |
| Started | October 10, 2023 |
| Main results expected | January 2026 |
| Study ends | January 2026 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT05866835 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are athletes aged 16 to 35 who are affiliated with the French Federation of Boxing, Rugby, or Football.
✕Probably not a fit
Patients with certain cardiovascular conditions or other pathologies that contraindicate participation in the trial may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project focuses on developing a new generation of custom-made intraoral protections (IOP) for athletes, particularly rugby players, using digital technologies like scanning and 3D printing. The aim is to address barriers such as long fabrication times, high costs, and compatibility issues with orthodontic treatments. The study will evaluate the impact of these new IOPs on athletes' ventilatory performance and comfort during use. By simplifying the manufacturing process and ensuring compliance with health standards, the researchers hope to improve access to effective protective gear for athletes.
Why it matters
Potential benefit: If successful, this study could enhance athletes' performance and safety by providing more effective and accessible intraoral protections.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving athlete safety and performance through custom protective gear.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects between the ages of 16 and 35, * Subject affiliated to a social security system, * Subject affiliated with the French Federation of Boxing or Rugby or Football * Subject having signed a consent form * For minors, legal guardians having signed the free and informed consent form Exclusion Criteria: * Subject with a pathology incompatible with the realization of the trial: * Absolute contraindications: Recent infarction (wait 5 to 12 days depending on severity), Threat syndrome (lawful test after stabilization - at least 3 days without spontaneous seizures), Resting BP \> 200/120 mmHg, Uncompensated heart failure, Third-degree Atrioventricular block, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac tumor or thrombus, Deep venous thrombosis, Pulmonary Embolism, * Relative contraindications: Aortic stenosis (formal contraindication if lipothymia, syncope or signs of heart failure), Severe non-revascularized coronary artery disease, Pulmonary arterial hypertension (formal contraindication if primary), Severe rapid ventricular or supraventricular arrhythmias * Subject under B-mimetic drug treatment, * Subject with decaying teeth, * Subject under court protection, * Subject participating in another research study, * Subject in pregnancy.
Where it's running
-
CREPS de Bordeaux
Bordeaux, France Recruiting -
CHU de Bordeaux
Bordeaux, France Not yet recruiting -
Institut national du sport, de l'expertise et de la performance (INSEP)
Paris, France Not yet recruiting
Study contacts
- Study coordinator: Philippe POISSON, Dr
- Email: philippe.poisson@chu-bordeaux.fr
- Phone: 0557656590
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.