Normative Assessment of Adaptable Mouthguards.

University Hospital, Bordeaux14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Oral Manifestations

Interventions

Adaptable mouthguardsDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: At Week 51

Impact on O2 consumption

Average of measured values in one minute, compared to reference of the subject

Time frame: At Week 51

Impact on respiratory rate

Average of measured values in one minute, compared to reference of the subject

Time frame: At Week 51

Impact on current volume

Average of measured values in one minute, compared to reference of the subject

Time frame: At Week 51

Impact on CO2 production

Average of measured values in one minute, compared to reference of the subject

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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