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 磨牙症包括不自觉的磨牙和咬紧下巴-这是最常见的睡眠之一- 相关的运动障碍，由于各种形式的压力，影响三分之一的美国成年人。最常见的非- 侵入性方法，以防止磨牙症相关的牙齿损害是一个夜间警卫。场外交易（OTC） 品牌可以在大多数药店以象征性的价格找到，但它们有显著的缺点，因为它们的 体积大、"一种尺寸适合所有人"的设计使它们不舒服、笨重，并且不方便用户佩戴 一整晚作为一种替代方案，有执照的牙医可以提供定制的夜间警卫，但大多数 牙科保险很少涵盖任何部分的费用，以及许多谁没有牙科保险。要么 大多数磨牙症病例几十年来都被低估了。这是因为大多数人不是由 知道他们的牙医的情况下，他们没有得到正确的诊断，他们的牙医，或没有获得 任何牙科护理。了解和教育的条件是至关重要的正确诊断和发展 有效的治疗方案。奥蒂斯牙科公司（奥蒂斯）提出开发奥蒂斯布鲁斯传感器夜间警卫 （OBSN），这是一种新颖的专利，无线定制夜间警卫系统与压力传感器，可以 定量测量睡眠期间的咬合压力。这项技术将由奥蒂斯 带有嵌入式电子系统的定制夜间防护装置，该系统连接到防护装置的一部分和盖子上 齿的轴向平面。传感器将产生并测量与咬合压力相对应的信号 由佩戴者在一段时间内产生的。奥蒂斯Brux传感器夜间警卫是一个真正的创新技术， 因为没有牙科产品或工具可以为患者提供有效的防磨牙症的保护， 同时收集实时数据，以获得更好的见解和治疗条件。如果成功，患者将 有机会获得技术先进的牙科用具，防止和消除磨牙症 症状，同时这也将为牙医提供先进的预防护理工具和软件 该平台监测和分析磨牙症压力和随时间的趋势，从而优化口腔 通过有效的患者治疗计划实现健康结果。在此，NIH重新提交了SBIR第一阶段， 奥蒂斯和Brash公司之间的合作，一个OBSN的工作原型，将被开发来测量， 分析并确定无/轻度和中度/重度磨牙症患者之间的作用力/趋势。统称 将追求以下技术目标：目标1。开发和优化奥蒂斯Brux传感器硬件， 捕获咬合压力的软件架构;目标2.电路传感器小型化 来自Aim 1的硬件组件，将被集成到奥蒂斯定制夜间警卫的臼齿区域中;以及Aim 3.对28名患者进行为期21天的可用性初步研究，以获取咬合压力曲线并优化 数据收集。第一阶段的完成将导致OBSN的工作原型，该原型将进一步优化 在II期，在更大的试验中使用统计学方法测量和区分不同的磨牙症水平。