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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bruxism, Sleep-Related

Intervention / Treatment
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* Device: BRUXENSE occlusal splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult from 18-70 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: patients with more than 2 missing tooth 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRUXENSE<br>Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights. | Device: BRUXENSE occlusal splint<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient rate with successful use of BRUXENSE occlusal splint | The BRUXENSE occlusal splints correct use in real situation will be evaluated by measuring the percentage of subjects able to use this occlusal splints during 10 consecutive nights (6 hours minimum) without any pain or any discomfort. 10 nights is the necessary delay to record sufficient data to make a diagnosis. | At day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of usable measurements | The quality of collected data will be determined by the number of measurements that can be used to make a diagnosis of bruxism after 10 consecutive nights | At day 10 | 
| Satisfaction scale score | Subject satisfaction will be assessed thanks to a numeric scale going from 0 (not satisfied at all) to 10 (completely satisfied) | At day 10 | 
| Proportion of patients diagnosed with bruxism | Proportion of patients diagnosed with bruxism according to the BRUXENSE occlusal splints after the analysis of the data collected during 10 days. | At day 10 |