Actively Recruiting
Validation of a Digitalised Intraoral Protection
Led by University Hospital, Bordeaux · Updated on 2025-08-08
60
Participants Needed
3
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Validation of a Digitalised Intraoral Protection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Subjects with pathologies incompatible with the trial, including:
- Recent infarction (wait 5 to 12 days depending on severity)
- Threat syndrome (test after stabilization with at least 3 days without seizures)
- Resting blood pressure over 200/120 mmHg
- Uncompensated heart failure
- Third-degree atrioventricular block
- Myocarditis, pericarditis, endocarditis
- Aortic dissection
- Intracardiac tumor or thrombus
- Deep venous thrombosis or pulmonary embolism
- Aortic stenosis with lipothymia, syncope, or heart failure signs
- Severe non-revascularized coronary artery disease
- Pulmonary arterial hypertension (especially 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 who is pregnant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
CHU de Bordeaux
Bordeaux, France
Not Yet Recruiting
2
CREPS de Bordeaux
Bordeaux, France
Actively Recruiting
3
Institut national du sport, de l'expertise et de la performance (INSEP)
Paris, France
Not Yet Recruiting
Research Team
P
Philippe POISSON, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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