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

摘要 磨牙症涉及到不自觉的磨牙和咬合下巴--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，影响到三分之一的美国成年人。最常见的非- 防止磨牙症相关牙齿损伤的侵入性方法是夜间守卫。场外交易(OTC) 大多数药店都可以以象征性的价格找到品牌，但它们有很大的缺点，因为它们的 笨重、一刀切的设计使它们不舒服、笨重，不方便用户佩戴 彻夜不眠。作为另一种选择，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，以及许多没有牙科保险的人。要么 几十年来，大多数布鲁克斯症病例都被漏报了。这是因为大多数人不是天生的 知道他们的牙医的情况，他们没有得到他们的牙医正确的诊断，或无法访问 任何牙科护理。对这种情况的认识和教育是正确诊断和发展的关键 一个有效的治疗计划。奥的斯牙科公司(奥的斯)计划开发奥的斯布鲁克斯传感器夜间警卫 (OBSN)，这是一种新型的、获得专利的无线定制夜间守卫系统，带有压力传感器，可以 定量测量睡眠时的咬合力。这项技术将由奥的斯 带有嵌入式电子系统的定制夜间警卫，该系统耦合到警卫的一部分和护罩上 牙齿的轴面。该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。奥的斯布鲁克斯传感器夜间警卫是一项真正的创新技术， 由于目前还没有能为患者提供有效预防磨牙症的牙科产品或工具 同时收集实时数据，以获得更好的见解并治疗病情。如果成功，患者将 可以使用技术先进的牙科器械来预防和缓解粘液中毒 症状同时出现。这也将为牙医提供先进的预防性护理工具和软件 该平台可监控和分析磨牙症随时间推移的压缩力和趋势，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， 奥的斯与Brash Inc.的合作，Brash Inc.是OBSN的工作原型，将被开发用于测量， 分析并确定无磨牙症/轻度磨牙症和中度/重度磨牙症患者之间的力量/趋势。团结在一起， 将追求以下技术目标：目标1.开发和优化奥的斯布鲁克斯传感器硬件和 捕获咬合力的软件架构；目标2.使电路传感器小型化 来自目标1的硬件组件将被集成到奥的斯海关夜间警卫的磨牙区域；以及目标 3.对28名患者进行为期21天的可用性先导研究，以捕获咬合力分布并优化 数据收集。第一阶段的完成将导致OBSN的工作原型，该原型将得到进一步优化 在第二阶段，在一项更大的试验中，使用统计手段来测量和区分不同程度的磨牙症。

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.