Otis Brux-Sensor Night Guard - a novel wireless custom night guard system with pressure sensors to quantitatively measure bite compression forces and alleviate sleep bruxism - Abstract
Bruxism involves the involuntary grinding of teeth and clenching of the jaw – it is one of the most common sleep-
related movement disorders, affecting 1 in 3 US adults due to various forms of stress. The most common non-
invasive method to protect against bruxism-related teeth damage is a night guard. The over-the-counter (OTC)
brands can be found in most drug stores at a nominal price, but they come with significant drawbacks, as their
bulky, “one-size-fits-all” design makes them uncomfortable, cumbersome, and inconvenient for users to wear
throughout the night. As an alternative, custom-made night guards are available by a licensed dentist, but most
dental insurances rarely cover any portion of the cost, as well as many who do not have dental insurance. Either
way, most Bruxism cases have gone underreported for decades. This is because most people are not made
aware of the condition by their dentist, they are not properly diagnosed by their dentist, or do not have access to
any dental care. Awareness and education of the condition are critical for proper diagnosis and the development
of an effective treatment plan. Otis Dental, Inc. (Otis) proposes to develop the Otis Brux-Sensor Night Guard
(OBSN), which is a novel, patented, wireless custom night guard system with pressure sensors that can
quantitatively measure bite compression forces during sleep. The technology will be comprised of the Otis
Custom Night Guard with an embedded electronics system that is coupled to a portion of the guard and covers
an axial plane of a tooth. The sensor will produce and measure signals corresponding to bite compression forces
generated by a wearer over a period of time. The Otis Brux-Sensor Night Guard is a truly innovative technology,
as there are no dental products or tools that can provide effective protection against bruxism for patients while
simultaneously collecting real-time data to gain better insights and treat the condition. If successful, patients will
have access to a technologically advanced dental appliance that protects against and alleviates Bruxism
symptoms, simultaneously. This will also provide dentists with an advanced preventative care tool and software
platform that monitors and analyzes bruxism compression forces and trends over time, thereby optimizing oral
health outcomes through effective patient treatment planning. Herein this NIH resubmitted SBIR Phase I, in
collaboration between Otis and Brash Inc., a working prototype of the OBSN that will be developed to measure,
analyze, and identify forces/trends between patients with no/mild and moderate/severe bruxism. Together, the
following technical aims will be pursued: Aim 1. Develop and optimize the Otis Brux-Sensor hardware and
software architectures to capture bite compression forces; Aim 2. Miniaturize the electrical circuit sensor
hardware component from Aim 1 to be integrated into the molar region of the Otis custom night guard; and Aim
3. Conduct a 21-day usability pilot study with 28 patients to capture bite compression force profiles and optimize
data collection. Phase I completion will lead to a working prototype of the OBSN, which will be further optimized
in Phase II to measure and distinguish different bruxism levels using statistical means in a larger trial.
