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.
Public Health Relevance Statement: Project Narrative Sleep bruxism is one of the most common sleep-related movement disorders, but this condition is underreported due to the population 1) left unaware of the condition, 2) are not properly diagnosed by their dentist, 3) or do not have access to dental care. Otis Dental, Inc. is developing the Otis Brux-Sensor Night Guard - a novel, patented, wireless pressure sensor night guard system that can quantitatively measure bite compression forces during sleep. If successful, bruxism sufferers will have access to a technologically advanced custom night guard that both protects against and alleviates Bruxism symptoms, while providing dentists the ability to optimize patient treatment plans through an advanced preventative care tool and software platform.
Project Terms: 21+ years old; Adult Human; adulthood; Adult; Affect; NSAIDs; Non Steroidal Antiinflammatory Agents; Nonsteroidal Anti-Inflammatory Agents; Nonsteroidal Antiinflammatory Agents; Nonsteroidal Antiinflammatory Drug; non-steroidal anti-inflammatory drugs; non-steroidal antiinflammatory drugs; nonsteroidal anti-inflammatory drugs; Non-Steroidal Anti-Inflammatory Agents; Architecture; Engineering / Architecture; Awareness; Bite; Bruxism; Teeth Grinding Disorder; Clinical Research; Clinical Study; Data Collection; Dental Care; Dental Procedure; dental service; Dentists; Diagnosis; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Education; Educational aspects; Electronics; electronic; electronic device; Goals; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Dental Insurance; Dental Surgery Insurance; Oral Surgery Insurance; Orthodontia insurance; Orthodontic insurance; Periodontic insurance; dental health insurance; Jaw; Marketing; Mental Health; Mental Hygiene; Psychological Health; Methods; Mission; Movement Disorders; Dyskinesia Syndromes; Movement Disorder Syndromes; Persons; United States National Institutes of Health; NIH; National Institutes of Health; Oral health; dental health; Pain; Painful; Legal patent; Patents; Patients; Pilot Projects; pilot study; Power Sources; Power Supplies; Quality of life; QOL; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Sleep; Computer software; Software; Stress; Technology; Time; Tooth structure; Tooth; teeth; Toothache; Odontalgia; dental pain; dentalgia; tooth pain; Work; Measures; Price; pricing; customs; Custom; sensor; improved; Left; Phase; Dental; insight; Licensing; Opiates; Opioid; Development Plans; Collaborations; tool; teeth clenching; bruxing; teeth grinding; Severities; System; Location; innovative technologies; success; treatment planning; novel; Devices; Sleep Bruxism; Nocturnal Bruxism; Nocturnal Teeth Grinding Disorder; miniaturize; miniaturized; Provider; preventing; prevent; Address; Symptoms; Data; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; transmission process; Transmission; trend; Preparation; preparations; Development; developmental; web site; website; oral care; cost; designing; design; Outcome; Population; Coupled; innovate; innovative; innovation; usability; prototype; patient population; effective treatment; effective therapy; Preventative care; Preventive care; Temporal trend; Trends over time; Time trend; pressure sensor; wireless; botulinum neurotoxin injection; BoNT injection; botox injection; botulinum toxin injection
