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Validation of a Digitalised Intraoral Protection

NCT05866835 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-08

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05866835 on ClinicalTrials.gov