Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-28 @ 10:39 PM
Study NCT ID:
NCT03325920
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2017-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Diagnostic Method for Quantification of Sleep Bruxism
Sponsor:
Heinrich-Heine University, Duesseldorf
Organization:
Study Overview
Official Title:
Validation of a Diagnostic Method for Quantification and Monitoring of Sleep Bruxism
Status:
COMPLETED
Status Verified Date:
2021-03
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:
DIABRUX
Brief Summary:
This study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism.
Detailed Description:
Sleep bruxism has characteristically been defined by the American Academy of Sleep Medicine as 'an oral activity characterized by grinding or clenching of the teeth during sleep, usually associated with sleep arousals'. For sleep bruxism diagnosis, to date the polysomnographic recordings represent the highest standard for sleep bruxism diagnosis, but they are concomitantly associated with disadvantages which include technical complexity, limited availability, and the fact that they are time-consuming and cost-intensive. Recently, a prototype of a diagnostic plate has been developed which allows a fully-automatic, computer-based quantification of abrasion thereupon for the assessment of sleep bruxism activity. The results of the pilot study were promising, and therefore, the aim of the present study is to refine and validate this new diagnostic method for quantification and monitoring of sleep bruxism.
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?: