Validation of a Digitalised Intraoral Protection

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 10, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Ventilatory Performances of Athletes During the Use of the Intra-oral Protections
Interventions
OTHER

Manufacture of custom-made IOP

"Manufacture of custom-made unimaxillary and modified unimaxillary intra-oral protection (IOP) with vertical dimensions of 4 mm and 6 mm. 3D modeling of a IOP based on:~* digital recording of the maxillary and mandibular dental arches~* mandibular wedging performed with an inter-arch piece~* digital recording of the inter-arch position"

OTHER

Ventilation tests

"Realization of a ventilation test (VO2max) to determine the Maximum Aerobic Speed (MAS).~Measurement of ventilatory parameters without IOP and with each IOP :~* At rest, standing still.~* During a 4 minute run on a treadmill at 50% of MAS.~* During a 4-minute run on a treadmill, at a speed corresponding to 70% of MAS"

OTHER

Evaluation of comfort level:

Collection from participants (self-questionnaire)

Trial Locations (3)

Unknown

NOT_YET_RECRUITING

CHU de Bordeaux, Bordeaux

RECRUITING

CREPS de Bordeaux, Bordeaux

NOT_YET_RECRUITING

Institut national du sport, de l'expertise et de la performance (INSEP), Paris

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER