Normative Assessment of Adaptable Mouthguards.

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 29, 2012

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: SIngle arm
    • The research is based on a population of men and women practicing a sport at risk of oral trauma.

Clinical Trial Outcome Measures

Primary Measures

  • Impact on ventilatory flow rate by minute
    • Time Frame: 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
    • Time Frame: At Week 51
    • Average of measured values in one minute, compared to reference of the subject
  • Impact on respiratory rate
    • Time Frame: At Week 51
    • Average of measured values in one minute, compared to reference of the subject
  • Impact on current volume
    • Time Frame: At Week 51
    • Average of measured values in one minute, compared to reference of the subject
  • Impact on CO2 production
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Bordeaux
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe POISSON, Dr, Principal Investigator, University Hospital, Bordeaux

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