Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
NCT ID: NCT03363204
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2018-02-08
2018-12-28
Brief Summary
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This study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism in ambulatory evaluation.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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BRUXENSE
Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* patients diagnosed with bruxism according to the following criteria:
* positive question at one of the following question:
* are you aware of your grinding?
* does your partner hear you grinding?
* are you aware that you are frequently tighten your jaws during the day and/or the night?
* are you tired and/or do experience jaws 'muscular pain in the morning.
* presence of at least one criteria:
* abnormal tooth wear or tooth prosthesis damages
* Hypertrophy of the masseter muscles
* patients agreeing to participate
* patient able to understand and follow the protocol
* patient with health insurance
Exclusion Criteria
* Severe troubles to correctly close the mouth.
* neurological disorder (Parkinson, Alzheimer) or psychiatric disorder
* Sleep disorder (insomnia, narcolepsy, sleep apnea, restless leg disorder)
* use of drugs that potentially impair sleep (benzodiazepines, neuroleptics, tricyclic antidepressants) alcohol or narcotics.
* complete or partial removal dental prosthesis or orthodontic device
* Patient under legal protection
* pregnant women
* Patients deprived of their freedom by a judicial or administrative decision
18 Years
70 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon
Lyon, France, France
Countries
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References
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Robin O, Claude A, Gehin C, Massot B, McAdams E. Recording of bruxism events in sleeping humans at home with a smart instrumented splint. Cranio. 2022 Jan;40(1):14-22. doi: 10.1080/08869634.2019.1708608. Epub 2020 Jan 8.
Other Identifiers
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69HCL17_0281
Identifier Type: -
Identifier Source: org_study_id