Validation of a Diagnostic Method for Quantification of Sleep Bruxism

NCT ID: NCT03325920

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2020-07-31

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.

Conditions

Sleep Bruxism; Diagnosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Sleep bruxism group

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

Group Type: EXPERIMENTAL

DIABRUX

Intervention Type: DEVICE

All participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity.

non-sleep bruxism group

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

Group Type: EXPERIMENTAL

DIABRUX

Intervention Type: DEVICE

All participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity.

Interventions

DIABRUX

All participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity.

Intervention Type: DEVICE

Other Intervention Names

Diagnostic plate

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.

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle A Ommerborn, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Düsseldorf/Heinrich-Heine-University Düsseldorf

Locations

Poliklinik für Zahnerhaltung, Parodontologie und Endodontologie Universitätsklinikum der Heinrich-Heine- Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 16106717 (View on PubMed)

Other Identifiers

2017094440

Identifier Type: -

Identifier Source: org_study_id