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The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIngle arm | Experimental | The research is based on a population of men and women practicing a sport at risk of oral trauma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptable mouthguards | Device | 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). |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe POISSON, Dr | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Pôle Médecine et chirurgie bucco-dentaire | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25311336 | Result | Guerard S, Barou JL, Petit J, Poisson P. Characterization of mouth-formed mouthguards: thermal performance. Dent Mater J. 2014;33(6):799-804. doi: 10.4012/dmj.2014-044. Epub 2014 Oct 11. |
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| ID | Term |
|---|---|
| D009912 | Oral Manifestations |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single
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| At Week 52 |