ENORMPIBA: Normative Assessment of Adaptable Mouthguards.
Study Details
Study Description
Brief Summary
The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SIngle arm The research is based on a population of men and women practicing a sport at risk of oral trauma. |
Device: Adaptable mouthguards
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).
|
Outcome Measures
Primary Outcome Measures
- Impact on ventilatory flow rate by minute [At Week 51]
Average of measured values in one minute, compared to maximum aerobic reference speed of the subject Modification of the ventilatory flow rate by min
- Impact on O2 consumption [At Week 51]
Average of measured values in one minute, compared to reference of the subject
- Impact on respiratory rate [At Week 51]
Average of measured values in one minute, compared to reference of the subject
- Impact on current volume [At Week 51]
Average of measured values in one minute, compared to reference of the subject
- Impact on CO2 production [At Week 51]
Average of measured values in one minute, compared to reference of the subject
- Impact on comfort according an analogical visual scale for 11 criteria [At Week 51]
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)
- Impact on electromyographic recording [At Week 52]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Bordeaux
Investigators
- Principal Investigator: Philippe POISSON, Dr, University Hospital, Bordeaux
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHU Bx 2011/04