Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Patient rate with successful use of BRUXENSE occlusal splint
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BRUXENSE
Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights.
Intervention: BRUXENSE occlusal splint (Device)
Outcomes
Primary Outcomes
Patient rate with successful use of BRUXENSE occlusal splint
Time Frame: At day 10
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.
Secondary Outcomes
- Satisfaction scale score(At day 10)
- Proportion of patients diagnosed with bruxism(At day 10)
- Number of usable measurements(At day 10)