Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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adult from 18-70
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patients diagnosed with bruxism according to the following criteria:
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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.
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presence of at least one criteria:
- abnormal tooth wear or tooth prosthesis damages
- Hypertrophy of the masseter muscles
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patients agreeing to participate
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patient able to understand and follow the protocol
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
7 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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