Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT03325920
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT03325920
Study Brief:
Protocol Section:
NCT03325920