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

Otis Brux-Sensor Night Guard - 一种新型无线定制夜间防护系统，带有压力传感器，可定量测量咬合压力并缓解睡眠磨牙症

• 批准号: 10684494
• 负责人: Richard Beranek
• 金额: $ 29.98万
• 依托单位: OTIS DENTAL, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-17 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10684494
• 关键词: Address; Adult; Affect; Architecture; Awareness; Bite; Bruxism; Clinical Research; Collaborations; Computer software; Coupled; Custom; Data; Data Collection; Dental; Dental Care; Dental Insurance; Dentists; Development; Development Plans; Devices; Diagnosis; Education; Electronics; Goals; Health Personnel; Jaw; Left; Legal patent; Licensing; Location; Marketing; Measures; Mental Health; Methods; Mission; Monitor; Movement Disorders; Non-Steroidal Anti-Inflammatory Agents; Opioid; Oral health; Outcome; Pain; Patients; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Power Sources; Preparation; Preventive care; Price; Provider; Quality of life; Severities; Signal Transduction; Sleep; Sleep Bruxism; Small Business Innovation Research Grant; Stress; Symptoms; System; Technology; Time; Time trend; Tooth structure; Toothache; United States National Institutes of Health; Work; botulinum neurotoxin injection; cost; design; effective therapy; improved; innovation; innovative technologies; insight; miniaturize; novel; oral care; patient population; pressure sensor; prevent; prototype; sensor; success; teeth clenching; tool; transmission process; treatment planning; trend; usability; web site; wireless

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.

摘要