Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study (NCT03363204) | Clinical Trial Compass
CompletedNot Applicable
Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
France7 participantsStarted 2018-02-08
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient rate with successful use of BRUXENSE occlusal splint