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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRUXENSE | Experimental | Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRUXENSE occlusal splint | Device | 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. |
| 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 |
| 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 |
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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:
presence of at least one criteria:
patients agreeing to participate
patient able to understand and follow the protocol
patient with health insurance
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon | Lyon | France | 69007 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31914871 | Result | 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. |
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| ID | Term |
|---|---|
| D020186 | Sleep Bruxism |
| ID | Term |
|---|---|
| D002012 | Bruxism |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020447 | Parasomnias |
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|
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 |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |