NCT04056559

Normative Assessment of Adaptable Mouthguards.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Manifestations

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2011-09-09
• Primary completion: 2012-06-29
• Completion: 2012-06-29
• First posted: 2019-08-14
• Last updated: 2019-08-14