Clinical trial NCT03325920: Validation of a Diagnostic Method for Quantification of Sleep Bruxism
Official title: Validation of a Diagnostic Method for Quantification and Monitoring of Sleep Bruxism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Bruxism
Diagnosis
Keywords: sleep bruxism
diagnosis
validation study
assessment
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, national, double-blind, controlled clinical trial with parallel group design
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Pixel score of the diagnostic plate
timeFrame: The DIABRUX plate should be worn for five consecutive nights. This will be performed by each participant at the earliest of the 12th and not later than the 85th days after screening.
Secondary outcomes:
measure: Psychologic load
timeFrame: Subjects who fulfill the inclusion criteria and none of the exclusion criteria should stipulate the first visit not later than 28 days after screening (day 0).
measure: Oral health-related quality of life
timeFrame: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
measure: Pain perception
timeFrame: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
measure: Dream experience
timeFrame: Recorded during the 2. and the 3. visit; this appointment may happen between the 2nd-57th day of study participation.
measure: Individual stress coping
timeFrame: Recorded during the 4. visit; this appointment may happen between the 5th-71th day of study participation.
measure: State-trait-Anxiety
timeFrame: Recorded during the 4. visit; this appointment may happen between the 5th-71th day of study participation.
measure: Subjective rating of the DIABRUX characteristics
timeFrame: The short questionnaire should be returned to the site together with the used DIABRUX plate. This will be performed by each participant at the earliest of the 12th and not later than the 85th days after screening.
Other outcomes:
measure: Assessment of probable sleep bruxism (clinical AASM criteria)
timeFrame: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
measure: Assessment of probable awake bruxism
timeFrame: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
measure: Presence of different forms of temporomandibular disorders
timeFrame: Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.
Locations:
city: Düsseldorf
country: Germany
facility: Poliklinik für Zahnerhaltung, Parodontologie und Endodontologie Universitätsklinikum der Heinrich-Heine- Universität Düsseldorf
state: NRW
Study officials:
affiliation: Universitätsklinikum Düsseldorf/Heinrich-Heine-University Düsseldorf
name: Michelle A Ommerborn, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ommerborn MA, Giraki M, Schneider C, Schaefer R, Gotter A, Franz M, Raab WH. A new analyzing method for quantification of abrasion on the Bruxcore device for sleep bruxism diagnosis. J Orofac Pain. 2005 Summer;19(3):232-8.