Validation of a Digitalised Intraoral Protection

NCT ID: NCT05866835

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2026-01-31

Brief 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

Detailed Description

Type III (custom) Intra Oral Protection (IOP) models represent 13% of IOP worn by amateur rugby players in France.

However, this model is recognized as the most effective when made in accordance with essential health and safety requirements.

This under-utilization can be explained by the existence of many barriers to the diffusion of custom-made IOP:

1. Organizational barrier: long fabrication procedure (minimum 3 sessions) requiring qualified people (dental surgeon, dental technician), trained in the technique of making custom IOP and in essential health and safety criteria.

2. Financial barrier: high cost with a selling price of 200€ to 300€ per unit.

3. Technical barriers:

• Difficulties in making custom-made IOP for athletes who wear fixed braces (brackets and wire),
• Difficulties in improving the impact energy dissipation capacity without affecting the absorption capacity of the custom-made IOP,
• Difficulties in individualizing and characterizing the IOP.

This observation is at the origin of a new approach proposed in order to remove the barriers to access to custom IOP. Naturally, this project relies on the combination of new digital technologies, scanning and 3D printing, to develop a new generation IOP with :

• A simpler and shorter procedure,
• A target price accepted by athletes,
• "French Association for Standardization"(AFNOR) standards guaranteed,
• Compatibility with fixed orthodontic treatments,
• Ability to develop new protection strategies,
• Ability to improve the athlete's comfort. Currently, the IOP resulting from these technologies are mainly "unimaxillary", i.e. without engagement of the mandibular dental arch and without ventilation space. In order to comply with the Afnor XP S72-427 standard, the project proposes the fabrication of two models of "modified unimaxillary" IOP that ensure the engagement of the mandibular dental arch and the creation of a ventilation space at two different heights, 4mm and 6mm. This project aims to show the interest of this new generation of "modified unimaxillary" IOP on the athlete's ventilation and his comfort when he evolves with his IOP in place. It is based on a population of men and women, minors and adults, practicing a sport at risk of oral trauma and uses a methodology already proven by the research team.

Conditions

Ventilatory Performances of Athletes During the Use of the Intra-oral Protections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Athlete

healthy, adult or minor (16 years or older), high-level sportsmen and women, volunteers

Group Type: EXPERIMENTAL

Manufacture of custom-made IOP

Intervention Type: OTHER

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

Intervention Type: OTHER

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:

Intervention Type: OTHER

Collection from participants (self-questionnaire)

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

Intervention Type: 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

Intervention Type: OTHER

Evaluation of comfort level:

Collection from participants (self-questionnaire)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Bordeaux

Bordeaux, , France

Site Status: NOT_YET_RECRUITING

CREPS de Bordeaux

Bordeaux, , France

Site Status: RECRUITING

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

Paris, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Philippe POISSON, Dr

Role: CONTACT

philippe.poisson@chu-bordeaux.fr

0557656590

Facility Contacts

Philippe POISSON, Dr

Role: primary

philippe.poisson@chu-bordeaux.fr

Serge LISE, Dr

Role: primary

serge.lise@creps-bordeaux.fr

Sébastien LE GARREC, Dr

Role: primary

sebastien.legarrec@insep.fr

Other Identifiers

CHUBX 2022/61

Identifier Type: -

Identifier Source: org_study_id