Normative Assessment of Adaptable Mouthguards.

Not Applicable

Completed

• Conditions: Oral Manifestations
• Interventions: Device: Adaptable mouthguards

• Registration Number: NCT04056559
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-09-09
• Primary Completion: 2012-06-29
• Study Completion: 2012-06-29
• Status Verified: 2019-08
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIngle arm	Adaptable mouthguards	The research is based on a population of men and women practicing a sport at risk of oral trauma.

Primary Outcome Measures

Name	Time	Method
Impact on O2 consumption	At Week 51	Average of measured values in one minute, compared to reference of the subject
Impact on CO2 production	At Week 51	Average of measured values in one minute, compared to reference of the subject
Impact on respiratory rate	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	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 current volume	At Week 51	Average of measured values in one minute, compared to reference of the subject
Impact on ventilatory flow rate by minute	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 electromyographic recording	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.