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Validation of a Diagnostic Method for Quantification of Sleep Bruxism

NCT03325920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-03-11

No results posted yet for this study

Summary

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

Conditions

  • Sleep Bruxism
  • Diagnosis

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Michelle A Ommerborn, Dr. · Universitätsklinikum Düsseldorf/Heinrich-Heine-University Düsseldorf

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325920 on ClinicalTrials.gov