Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-12 @ 8:12 PM
Study NCT ID:
NCT04056559
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2019-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normative Assessment of Adaptable Mouthguards.
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Normative Assessment of Adaptable Mouthguards.
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENORMPIBA
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: