Rapid Plaque Removal by a Sonic & Ultrasonic Toothbrush

描述（由申请人提供）：绝大多数公众依赖手动牙刷作为去除牙菌斑的主要工具，从而预防最常见的口腔疾病（龋齿、牙龈炎和牙周炎）。然而，手动牙刷的功效存在两个主要障碍：（1）患者在每天使用手动牙刷两次持续足够的时间段（至少2分钟）以有效地去除牙菌斑方面的顺应性;以及（2）牙菌斑去除不充分，因为它仅发生在与刷毛直接接触的牙齿表面上。30%的美国人使用的电动牙刷提供了更好的口腔健康的潜力，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牙菌斑，并且由刷毛运动产生的弱流体力可以去除一些刷毛直接触及范围之外的牙菌斑。然而，即使是最好的电动牙刷也需要至少2分钟的刷牙时间才能达到最佳效果（同时留下显著的邻间和龈下菌斑）。因此，开发一种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超出刷毛触及范围的大部分牙菌斑的电动牙刷，可以显著改善口腔健康-这是该多阶段SBIR项目的目标。第一阶段的结果表明，电动牙刷的可行性，结合了一种新的声波和超声波物理过程的组合，以快速，安全地消除牙菌斑的水平远远超过现有的电动牙刷的能力。第一阶段的结果是用一种经过适当改造的电动牙刷获得的，这种牙刷具有明显的制造潜力。本文提出的实质性II期工作的目的是：1）通过体外试验最终确定声波和超声条件的选择，以实现最佳牙菌斑去除和安全性; 2）优化所提出牙刷的声学效率、可靠性和耐用性设计; 3）在人体临床研究中研究最终牙刷的有效性和安全性。能够在短的刷牙时间内去除刷毛可及范围内和超出刷毛可及范围的大部分牙菌斑的电动牙刷的开发将标志着口腔健康的显著进步。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，第二行为伙伴将继续追求其商业计划，并将筹集私营部门资本，以开始制造和营销。这款新产品将满足目前美国超过10亿美元、全球超过20亿美元的电动牙刷市场需求，该市场每年增长11%。

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.