4 Clinical Trials for Various Conditions
The goal of this study is to determine if the Otis Brux-Sensor Night Guard (OBSNG) can record the bite compression forces of participants with Bruxism. The main questions it aims to answer is: 1. Is it possible to design and miniaturize electrical hardware components small enough to fit onto the molar region of the custom night guard? 2. If successfully miniaturized, will we be able to capture bite compression force profiles and optimize data collection for analysis? Participants would wear the device for 21 days, over a 6+ hour sleep period each night.
The overall objective of the clinical studies with the OstiSense biosensor tool will be to evaluate whether the use of the OstiSense biosensor tool significantly reduces the number of sleep bruxism events per night as well as the duration of those events for patients with bruxism.The product under investigation is the OstiSense biosensor with biofeedback for bruxism therapy. The sensor is integrated in a night-guard like device and registers the pressure created during a bruxism episode. If a predetermined pressure threshold is exceeded, the integrated vibration tool will be activated, and the vibrations will/should remind the wearer to stop clenching his jaws and relax his facial muscles. Due to this feedback, the number of bruxism episodes as well as clenching time per episode should be reduced. The sensor also identifies the time of grinding and the sleep stage of the patient.
Clinical trials of bite splint use and night time tooth grinding have not been performed. Consequently, there are no definitive outcome measures or efficacy standards that can be applied to large clinical trials. The present preliminary trial will determine what objective measures can be used to evaluate efficacy. The outcome variables will fall into four categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard, (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic 'bite splint' or 'orthotic', hereafter called the "Michigan bite splint", to compare the performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the outcome variables identified in this study for broader clinical trials. Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in clinical laboratory conditions. Hypothesis: There will be no significant differences between the devices in terms of fabrication efficacy, functional efficacy or user satisfaction. Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be no significant differences between the devices in terms of compliance or functional efficacy.
The purpose of this study is to determine whether botulinum toxin helps patients with bruxism.