Normative Assessment of Adaptable Mouthguards.

Study Overview
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Brief Summary
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The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.

Detailed Description
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The current state of knowledge in the areas of mouthguards shows that type II (adaptable) models account for 90% of the mouthguards of the sporting population. But a majority of these devices do not appear to comply with the European Directive 89/686 / European Economic Community. A previous work consisted of the production of prototypes of mouthguards meeting the essential requirements of the directive. These prototypes were the subject of a patent filed by the Bordeaux University and the Bordeaux University Hospital. The aim of this study is to the validate the prototypes for a future launch on the market.

Official Title
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Normative Assessment of Adaptable Mouthguards.

Conditions
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Oral Manifestations

Intervention / Treatment
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* Device: Adaptable mouthguards


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject aged 18 to 35, Subject affiliated to a social security, Subject who has signed the free and informed consent form. Exclusion Criteria: Subject with a pathology incompatible with the performance of the test, namely: Recent infarction,Threat syndrome, blood pressure resting> 200/120 mmHg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac Tumor or Thrombus, Deep Vein Thrombosis, Pulmonary Embolism, Subject under B-mimetic drug treatment, Subject under safeguard of justice, Subject participating in another search, Subject during pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIngle arm<br>The research is based on a population of men and women practicing a sport at risk of oral trauma. | Device: Adaptable mouthguards<br>* Validate a prototype of Adaptable Intra-Oral Protections patented by Bordeaux University and Bordeaux University Hospital according to 3 levels (ventilation, comfort, cervical muscle activity).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on ventilatory flow rate by minute | Average of measured values in one minute, compared to maximum aerobic reference speed of the subject Modification of the ventilatory flow rate by min | At Week 51 | 
| Impact on O2 consumption | Average of measured values in one minute, compared to reference of the subject | At Week 51 | 
| Impact on respiratory rate | Average of measured values in one minute, compared to reference of the subject | At Week 51 | 
| Impact on current volume | Average of measured values in one minute, compared to reference of the subject | At Week 51 | 
| Impact on CO2 production | Average of measured values in one minute, compared to reference of the subject | At Week 51 | 
| Impact on comfort according an analogical visual scale for 11 criteria | According an analogical visual scale (from 0 to 10) for 11 criteria (retention, muco-gingival appearance, mouth opening height, volume of mouthguards, nausea, phonation, open mouth ventilation, tight jaw ventilation, salivation, masticatory muscles, temporomandibular joint) | At Week 51 | 
| Impact on electromyographic recording | The electromyographic activity will be amplified and filtered (bandwidth 10-1000 Hz). The signals will be digitized using a CED 1401 interface coupled to a microcomputer that is controlled by the SPIKE2 software. The digitization frequency will be 2,000 Hz. The software SPIKE2 will then calculate what is called integrated electromyogram: the electromyographic signals will be rectified and filtered with a moving average having a period of 0,2 seconds. | At Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prototype, Adaptable mouthguards