Status:
COMPLETED
Validation of a Diagnostic Method for Quantification of Sleep Bruxism
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Sleep Bruxism
Diagnosis
Eligibility:
All Genders
20-50 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- Patient has signed and understood the approved informed consent form and is able to meet the proposed study proceedings
- for the sleep bruxism Group: subjects have to fulfill the clinical criteria of the American Academy of Sleep Medicine (sleeping partner's Report of grinding sounds during sleep within the last 6 months, plus at least one of the following symptoms: abnormal attrition of the teeth or shiny spots on dental restorations, hypertrophy of the masseteric muscle upon palpation, and/or self-report of muscle fatigue on awakening. In addition to the clinical criteria for sleep bruxism diagnosis, the following polysomnographic criteria have to be present: bruxism episodes/hr \>4, bruxism burst/hr \>25, at least one episode of grinding per sleep period
- Subjects that do not meet any of the clinical or polysomnographic criteria for sleep bruxism were included into the non-sleep bruxism group.
Exclusion
- current participation in another interventional Investigation
- cardiac Pacemaker
- central nervous system and peripheral nervous system disorders
- use of sedating medications and/or psychopharmacologically effective drugs
- suspected severe psychological disorder (for example schizophrenia)
- a lack of German language
- drug and/or alcohol abuse
- pregnancy or breast-feeding
- Participants of the sleep bruxism group that do not meet any of the clinical or polysomnographic criteria for sleep bruxism were excluded from the sleep bruxism group.
- Participants of the non-sleep bruxism group that fulfill the clinical and/or polysomnographic criteria for sleep bruxism were excluded from the non-sleep bruxism group.
- Further dental exclusion criteria are:
- prostheses or extensive prosthetic restorations
- dental functional treatment during the last 6 months
- gross malocclusion
- too many missing teeth that omit fabricating a diagnostic plate
- fixed brace
- temporomandibular dysfunction requiring treatment
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03325920
Start Date
May 20 2019
End Date
July 31 2020
Last Update
March 11 2021
Active Locations (1)
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1
Poliklinik für Zahnerhaltung, Parodontologie und Endodontologie Universitätsklinikum der Heinrich-Heine- Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225