Validation of a Digitalised Intraoral Protection

Launched by UNIVERSITY HOSPITAL, BORDEAUX · May 10, 2023

Keywords

ClinConnect Summary

**Trial Summary: Validation of a Digitalised Intraoral Protection**

This clinical trial is studying a new type of custom-made mouthguard, called intra-oral protection (IOP), designed to help athletes breathe better while playing sports. These mouthguards are especially important for rugby players, as they can help protect the mouth and improve comfort during games. The researchers are using advanced technology like 3D printing to create these mouthguards, hoping to make them more accessible and effective for young athletes. The trial will look at how well these new mouthguards support athletes' breathing and comfort levels while they use them.

To participate in this study, you need to be between 16 and 35 years old, and you must be a member of a social security system in France. You also need to be involved with a sports organization, such as boxing, rugby, or football, and provide signed consent to join the trial. Participants can expect to wear the new mouthguard during their sports activities and provide feedback about their experiences. It’s important to note that certain medical conditions, such as serious heart problems or pregnancy, may prevent someone from participating in this study. If you're interested, this trial could be a great opportunity to contribute to sports safety and innovation!

Gender

ALL

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.