An interventional study of BRUXENSE occlusal splint in Bruxism, Sleep-Related, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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.
62 studies on the registry are indexed under Sleep Bruxism; 11 are open to participants now.
This study's enrollment of 7 is below the median of 39 across 38 interventional studies indexed under Sleep Bruxism.
Browse Sleep Bruxism studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
positive question at one of the following question:
presence of at least one criteria:
Exclusion Criteria:
Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights.
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.
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.
Time frame: At day 10
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
Time frame: 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)
Time frame: 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.
Time frame: At day 10
Ran from Feb 2018 to primary completion in Dec 2018, 10 months.
Of 19 interventional studies with no phase under Sleep Bruxism, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 10 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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