Validation of a Digitalised Intraoral Protection

Recruiting now · Not applicable

Conditions studied: Ventilatory Performances of Athletes During the Use of the Intra-oral Protections

In brief

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

Key facts

Study ID

NCT05866835

Run by

University Hospital, Bordeaux

People needed

60

Starts

2023-10-10

Expected to finish

2026-01-01

Last updated by the study team

2025-08-08

Who can join

Age: 16 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• CREPS de Bordeaux — Bordeaux, France (enrolling)
• CHU de Bordeaux — Bordeaux, France
• Institut national du sport, de l'expertise et de la performance (INSEP) — Paris, France

Full record on ClinicalTrials.gov

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