Normative Assessment of Adaptable Mouthguards. (ENORMPIBA)

University Hospital of Bordeaux

Status

Completed

Conditions

Oral Manifestations

Treatments

Device: Adaptable mouthguards

Study type

Interventional

Funder types

Other

Identifiers

NCT04056559

CHU Bx 2011/04

Details and patient eligibility

About

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

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.