Validation of a Diagnostic Method for Quantification of Sleep Bruxism

NCT03325920 | Completed

• 1 other identifier: 2017094440
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Bruxism; Diagnosis

Keywords

sleep bruxism; diagnosis; validation study; assessment

Outcome Measures

Primary Outcomes (1)

• Pixel score of the diagnostic plate

  Quantitative measure of sleep bruxism activity

  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 (7)

• Psychologic load

  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).

• Oral health-related quality of life

  Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.

• Pain perception

  Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.

• Dream experience

  Recorded during the 2. and the 3. visit; this appointment may happen between the 2nd-57th day of study participation.

• Individual stress coping

  Recorded during the 4. visit; this appointment may happen between the 5th-71th day of study participation.

Other Outcomes (3)

• Assessment of probable sleep bruxism (clinical AASM criteria)

  Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.

• Assessment of probable awake bruxism

  Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.

• Presence of different forms of temporomandibular disorders

  Recorded during the 1. visit; this appointment may happen between the 1st-28th day of study participation.

Study Arms (2)

Sleep bruxism group

EXPERIMENTAL

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

Device: DIABRUX

non-sleep bruxism group

EXPERIMENTAL

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

Device: DIABRUX

Interventions

DIABRUX 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.

Also known as: Diagnostic plate

Sleep bruxism group; non-sleep bruxism group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

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

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

• 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.

  PMID: 16106717 RESULT

MeSH Terms

Conditions

Sleep Bruxism; Disease

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle A Ommerborn, Dr.

  Universitätsklinikum Düsseldorf/Heinrich-Heine-University Düsseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, as well as the investigating dentist are blind to the result obtained from the polysomnographic recording. The statistican is also unaware of the sleep bruxism diagnosis.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, national, double-blind, controlled clinical trial with parallel group design

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 30, 2017
• Study Start: May 20, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)