Rapid Plaque Removal by a Sonic & Ultrasonic Toothbrush

说明(申请人提供)：绝大多数公众依赖手动牙刷作为清除牙菌斑的主要工具，从而预防最常见的口腔疾病(龋齿、牙周炎和牙周炎)。然而，手动牙刷的功效有两个主要障碍：(1)患者每天两次使用手动牙刷的时间足够长(至少2分钟)，以有效地去除牙菌斑；(2)牙菌斑去除不足，因为它只发生在与刷毛直接接触的牙齿表面。30%的美国人使用电动刷子，这为改善口腔健康提供了可能性，因为它们的快速刷毛运动可以更有效地去除刷毛触及范围内的菌斑，而刷毛运动产生的微弱流体力可能会去除一些刷毛无法直接接触到的菌斑。然而，即使是最好的电动牙刷也需要至少2分钟的刷牙才能达到最佳的效果(同时还会留下明显的近邻和牙龈下菌斑)。因此，开发一种电动牙刷，能够在较短的刷牙时间(例如1分钟)内清除刷毛触及范围内和刷毛范围外的大部分菌斑，可以显著提高口腔健康-这是这个多阶段SBIR项目的目标。第一阶段的结果表明，电动牙刷的可行性，它结合了声波和超声波物理过程的新组合，可以快速和安全地去除牙菌斑，其水平远远超过现有电动牙刷的能力。第一阶段的结果是通过适当改变动力牙刷获得的，该牙刷具有明显的制造潜力。这里提出的实质性第二阶段工作的目的是1)通过体外测试最终确定用于最佳牙菌斑去除和安全性的声学和超声波条件的选择，2)从声学效率、可靠性和耐用性方面优化建议牙刷的设计，以及3)在人体临床试验中调查最终牙刷的有效性和安全性。开发一种电动牙刷，能够在短时间内清除刷毛触及范围内和刷毛范围外的大部分菌斑，将标志着口腔健康的重大进步。第二阶段的成功将为第三阶段的商业化努力奠定基础，在此期间，Second Act Partners将继续执行其业务计划，并将筹集开始制造和营销所需的私营部门资本。这款新颖的产品将面向电动牙刷市场，目前美国市场规模超过10亿美元，全球市场规模超过20亿美元--这个市场正以每年11%的速度增长。

DESCRIPTION (provided by applicant): The overwhelming majority of the public relies on the manual toothbrush as the primary tool for removal of dental plaque and hence the prevention of the most common oral diseases (caries, gingivitis and periodontitis). However, there are two major obstacles to the efficacy of a manual toothbrush: (1) patient compliance in using a manual brush twice daily for a sufficient period of time (at least 2 minutes) to effectively remove plaque; and (2) inadequate plaque removal, as it only occurs on tooth surfaces directly contacted by the bristles. Power brushes, used by 30% of Americans, offer the potential for better oral health, because their rapid bristle motion can more effectively remove plaque within the reach of the bristles and weak fluid forces created by bristle motion may remove some of the plaque that is beyond the direct reach of their bristles. However, even the best power brushes require a minimum 2-minute brushing to achieve optimal results (while leaving significant interproximal and subgingival plaque). Therefore, the development of a power toothbrush capable of removing the majority of plaque both within reach of and beyond the reach of the bristles over a shorter brushing time (e.g. 1 minute) could provide a significant advance in oral health -which is the goal of this multi-phase SBIR project. Phase I results indicated the feasibility of a power toothbrush that incorporates a novel combination of sonic and ultrasound physical processes to rapidly and safely remove plaque at levels well beyond the capabilities of existing power toothbrushes. Phase I results were obtained with a suitably altered power toothbrush that has clear manufacturing potential. The purpose of the substantial Phase II work proposed here is to 1) finalize the choice of sonic and ultrasound conditions for optimal dental plaque removal and safety via in vitro assays, 2) optimize the design of the proposed toothbrush for acoustic efficiency, reliability and durability, and 3) investigate efficacy and safety of a finalized toothbrush in human clinical studies. The development of a power toothbrush capable of removing the majority of plaque both within reach of and beyond the reach of the bristles within a short period of brushing time would mark a significant advance in oral health. Success in Phase II will set the stage for a Phase III commercialization effort during which Second Act Partners will continue the pursuit of its business plan and will raise the private-sector capital required to begin manufacturing and marketing. This novel product will address a power toothbrush market that is currently over $1 billion in the US and over $2 billion worldwide - one that is growing at 11% per year.