The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Delivery of the vibratory biofeedback stimulus
Fondazione Irccs San Gerardo Dei Tintori
Monza, Monza E Brianza, Italy
Reduction of the bruxism activity
Evaluation of the efficacy of AesyBite Active in reducing the bruxism activity expressed as total sleep bruxism duration per hour (TDPH, sec/hour) by at least 60% in the stimulation phase compared with baseline with a 10% non-inferiority margin.
Time frame: 1 month
Reduction of the bruxism index
Evaluation of the efficacy of AesyBite Active in reducing the bruxism index expressed as number of sleep bruxism episodes per hour (episodes/hour).
Time frame: 1 month
Reduction of the mean duration of sleep bruxism episode
Evaluation of the efficacy of AesyBite Active in reducing the mean duration of sleep bruxism episodes (sec/episode).
Time frame: 1 month
Relative change in average intensity of bruxism episodes
A measure of the average bite strength exerted during the bruxism episodes.
Time frame: 1 month
Change in self-reported sleep quality marked on a visual analogue scale
Change in self-reported sleep quality assessed using a visual analogue scale (VAS) with a sleep quality scale from 0 to 10.
Time frame: 1 month
Change in self-reported pain marked on a visual analogue scale
Change in self-reported pain (facial pain, myofascial headache) assessed using a visual analogue scale (VAS) with a pain severity scale from 0 to 10.
Time frame: 1 month
Change in self-reported comfort marked on a visual analogue scale
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Change in self-reported comfort assessed using a visual analogue scale (VAS) with a comfort severity scale from 0 to 10.
Time frame: 1 month
Change in self-reported retention marked on a visual analogue scale
Change in self-reported retention assessed using a visual analogue scale (VAS) with a retention severity scale from 0 to 10.
Time frame: 1 month
Change in self-reported ease of breathing marked on a visual analogue scale
Change in self-reported ease of breathing assessed using a visual analogue scale (VAS) with a ease of breathing severity scale from 0 to 10.
Time frame: 1 month