NCT05866835 Validation of a Digitalised Intraoral Protection
| NCT ID | NCT05866835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Ventilatory Performances of Athletes During the Use of the Intra-oral Protections |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-10-10 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Type III (custom-made) intra-oral protection (IOP) models represent 13% of IOP worn by amateur rugby club players in France. However, this model is recognized as the most effective when made in accordance with essential health and safety requirements. This observation is at the origin of a new approach that the investigators are proposing with the objective of removing the barriers to access to custom-made IOP. This research is based on the combination of new digital technologies, scanning and 3D printing, to develop a new generation of IOP. This project aims to show the interest of this new generation of "modified unimaxillary" IOP on the ventilation of the athletes and his/her comfort when he/she evolves with his IOP in place
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05866835 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying Ventilatory Performances of Athletes During the Use of the Intra-oral Protections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05866835 currently recruiting?
Yes, NCT05866835 is actively recruiting participants. Contact the research team at philippe.poisson@chu-bordeaux.fr for enrollment information.
Where is the NCT05866835 trial being conducted?
This trial is being conducted at Bordeaux, France, Bordeaux, France, Paris, France.
Who is sponsoring the NCT05866835 clinical trial?
NCT05866835 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 60 participants.