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Validation of a Digitalised Intraoral Protection
Sponsor: University Hospital, Bordeaux
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
Official title: Validation of a Generic Procedure for the Fabrication of a Custom-made Intra-oral Protection Using an Inter-arch Piece
Key Details
Gender
All
Age Range
16 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-10-10
Completion Date
2026-01
Last Updated
2025-08-08
Healthy Volunteers
Yes
Interventions
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
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
Evaluation of comfort level:
Collection from participants (self-questionnaire)
Locations (3)
CHU de Bordeaux
Bordeaux, France
CREPS de Bordeaux
Bordeaux, France
Institut national du sport, de l'expertise et de la performance (INSEP)
Paris, France