Normative Assessment of Adaptable Mouthguards.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-09

Study Completion Date

2012-06-29

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.

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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.

Conditions

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Oral Manifestations

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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SIngle arm

The research is based on a population of men and women practicing a sport at risk of oral trauma.

Group Type EXPERIMENTAL

Adaptable mouthguards

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes