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.

抽象的 磨牙症涉及牙齿的非自愿磨碎和颌骨的紧握 - 它是最常见的睡眠之一 相关运动障碍，由于各种形式的压力，影响了三分之一的美国成年人。最常见的非 - 防止与磨牙相关的牙齿损伤的侵入性方法是夜总会。非处方（OTC） 品牌可以在大多数药店中以名义价格找到，但它们具有很大的缺点，因为 笨重的“千篇一律”设计使它们不舒服，笨拙且不便，使用户穿着 整夜。作为替代方案，定制的夜间护卫可供持牌牙医提供，但大多数 牙科保险很少支付任何一部分费用，以及许多没有牙科保险的人。任何一个 方式，大多数磨牙症案件被低估了数十年。这是因为大多数人不是 意识到牙医的病情，他们没有被牙医正确诊断，或者无法访问 任何牙科护理。对病情的认识和教育对于适当的诊断和发展至关重要 有效的治疗计划。 Otis Dental，Inc。（OTIS）提议开发Otis Brux-Sensor夜总会 （obsn），这是一种具有压力传感器的新颖，专利的无线定制夜间后卫系统 在睡眠期间定量测量咬合压缩力。该技术将完成OTIS 定制夜总会带有嵌入式电子系统，该系统耦合到一部分后卫并盖上 牙齿的轴向平面。传感器将产生并测量与咬合压缩力相对应的信号 由佩戴者在一段时间内生成。 Otis brux-Sensor夜间后卫是一项真正的创新技术， 由于没有牙科产品或工具可以为患者提供有效的防御磨牙保护 类似地收集实时数据以获得更好的见解并治疗状况。如果成功，患者将 可以使用技术先进的牙科设备，以防止和减轻磨牙症 症状很容易。这还将为牙医提供先进的预防性护理工具和软件 随着时间的推移，可以监视和分析磨牙症压缩力和趋势的平台，从而优化口头 通过有效的患者治疗计划得以健康结果。以下此NIH重新提交的SBIR第一阶段， Otis和Brash Inc.之间的协作，这是一个obsn的工作原型，将开发以衡量， 分析并确定无/轻度和中度/重度磨牙症患者之间的力量/趋势。在一起， 将追求以下技术目标：目标1。开发和优化Otis brux-sensor硬件和 软件体系结构以捕获咬合压缩力；目标2。将电路传感器微型化 将AIM 1的硬件组件集成到Otis Custom Night Guard的摩尔区域；和目标 3。对28例患者进行21天的可用性试点研究，以捕获咬合压缩力剖面并优化 数据收集。第一阶段的完成将导致obsN的工作原型，这将进一步优化 在II期中，在更大的试验中使用统计平均值来测量和区分不同的磨牙水平。