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RECRUITING
NCT05866835
NA

Validation of a Digitalised Intraoral Protection

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

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)

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