PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Gra

摘要 在第二阶段SBIR项目中，ASTER实验室将以以下形式增强免提自动口腔卫生设备： 在第一阶段研究中设计并成功测试和评估的舒适牙套 为口腔卫生残疾人及其护理人员提供服务，然后调查该设备在以下方面的功效： 减少牙菌斑，减轻负担，从而提高生活质量。很多神经系统疾病患者， 神经肌肉和发育障碍，包括那些遭受身体伤害或震颤的人， 口腔健康不良、龋齿、牙周病和软组织病变的风险高于那些 没有残疾。大约3200万残疾美国人在日常生活中遇到了障碍， 舒适，有效的口腔卫生护理，由于问题的把握，肌肉控制，运动范围， 减少灵活性。许多人面临独立性降低，需要护理人员协助进行日常牙科治疗， 在乎这些照顾者报告说，由于缺乏培训、时间， 或管理复杂口腔卫生护理的信心。对当前设备的调查，以帮助这些任务， 残疾人展示的只有有限的手动解决方案，包括保持嘴张开和修改的道具 牙刷柄目前的电动牙刷需要手动控制。不适当的日常卫生促进口腔 残疾人患病，由于资金有限， 医疗补助覆盖范围，以及有限的受过残疾护理培训的专业人员。未满足的重大需求 存在，以支持更好的口腔卫生为残疾人和他们的照顾者与安全，自动，负担得起的， 切实可行的解决方案，以促进日常牙科护理和减轻负担。为了解决这个问题，ASTER Labs，Inc. 已经开发出一种有效的和新颖的原型免提自动系统，以简化日常口腔卫生 在乎该装置使用动力移动刷毛在一个灵活的嘴，简单地插入口中， 轻轻清除牙齿和牙龈上的牙菌斑和碎屑。该设计包括多个功能，以确保舒适性 以及日常护理过程中的安全性，包括嵌入式传感器，以调节刷毛运动的强度和速度。 使用信息通过LCD显示器以无线方式传输给监护人， 充电和清洁基站。这些定期报告将通过防止中断， 日常卫生通过为这些弱势群体提供技术先进但实用的牙科保健系统， 人口在家中或护理设施使用，定期，有效的口腔卫生可以改善，降低风险 可预防的口腔疾病和治疗需求。本II期SBIR将评价该系统的有效性， 为患者和护理人员提供一种有效的、无需动手的日常口腔卫生护理方法， 生活质量，减少努力和困难，并坚持推荐的护理。随机 将使用半结构化访谈和收集的观察数据完成受控评价， 110名中度口腔卫生障碍者、家庭护理人员和/或专业护理提供者。

Abstract In this Phase II SBIR project, ASTER Labs will enhance a hands-free automatic oral hygiene device in the form of a comfortable mouthpiece that was designed and successfully tested and evaluated during a Phase I study for persons with oral hygiene disabilities and their caregivers, and then investigate the device’s efficacy in reducing dental plaque and reducing burden, thereby improving quality of life. Many people with neurological, neuromuscular, and developmental disorders, including those suffering physical injury or tremors, are at a higher risk of poor oral health, dental caries, periodontal disease, and soft tissue pathology compared to those without disability. This population of roughly 32 million disabled Americans encounters barriers to routine, comfortable, and effective oral hygiene care, due to problems with grasp, muscle control, range of motion, and reduced dexterity. Many face reduced independence, requiring caregiver assistance to perform daily dental care. These caregivers report great difficulty effectively performing these services due to lack of training, time, or confidence in managing complexities of oral hygiene care. Surveys of current devices to aid these tasks for disabled persons show only limited manual solutions, including props to keep the mouth open and modified toothbrush grips. Current electric toothbrushes require manual control. Inadequate daily hygiene promotes oral disease in the disabled, who are then subject to dental care access barriers due to limited finances, inadequate Medicaid coverage, and a limited pool of professionals trained in disability care. A significant unmet need exists to support better oral hygiene for the disabled and their caregivers with a safe, automatic, affordable, practical solution to promote daily dental care and reduce burden. To address this problem, ASTER Labs, Inc. has developed an effective and novel prototype hands-free automatic system to simplify routine oral hygiene care. The device uses powered moving bristles in a flexible mouthpiece, simply inserted into the mouth to gently remove plaque and debris from teeth and gums. The design includes multiple features to ensure comfort and safety during daily care, including embedded sensors to adjust intensity and speed of the bristle motion. Usage information is wirelessly transmitted to caregivers monitoring care status via an LCD display on a recharging and cleaning base station. These regular reports will promote adherence by preventing disruption in daily hygiene. By providing a technically advanced but practical dental care system for this vulnerable population to use in their homes or care facilities, regular, effective oral hygiene can be improved, reducing risk of preventable oral disease and need for treatment. This Phase II SBIR will evaluate efficacy of this system to provide patients and caregivers with an effective, hands-free method for routine oral hygiene care to improve quality of life, reduce effort and difficulty, and maintain adherence to recommended care. Randomized controlled evaluations will be completed using semi-structured interviews and observation data collected on 110 persons with moderate oral hygiene disabilities, family caregivers, and/or professional care providers.