Validation of a Diagnostic Method for Quantification of Sleep Bruxism (DIABRUX)

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Diagnosis; Sleep Bruxism

Treatments: Device: DIABRUX

Study type: Interventional

Funder types: Other

Identifiers

NCT03325920

2017094440

Details and patient eligibility

About

This study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups

Sleep bruxism group

Experimental group

Description:

25 sleep bruxism subjects wear the DIABRUX for five consecutive nights.

Treatment:

Device: DIABRUX

non-sleep bruxism group

Experimental group

Description:

25 non-sleep bruxism subjects wear the DIABRUX for five consecutive nights.

Treatment:

Device: DIABRUX