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Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study

NCT03363204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-12-19

No results posted yet for this study

Summary

There is no accurate diagnosis method for bruxism for now. Consequences of bruxism over teeth, muscles and articulation of the jaw are important.

This study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism in ambulatory evaluation.

Conditions

  • Bruxism, Sleep-Related

Interventions

DEVICE

BRUXENSE occlusal splint

Patients participating will put the BRUXENSE occlusal splint each night. During the night the device will collect data potentially related to bruxism. After each night the device will be cleaned with water and toothpaste and charged. This routine will be conducted over 10 consecutive nights.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2018-12-28
Completion
2018-12-28

Countries

  • France

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 NCT03363204 on ClinicalTrials.gov