Rapid Plaque Removal by a Sonic & Ultrasonic Toothbrush

说明（由申请人提供）：绝大多数市民使用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)患者每天使用两次手动牙刷，并持续足够的时间（至少2分钟）以有效清除牙菌斑；(2)牙菌斑清除不足，因为它只发生在与刷毛直接接触的牙齿表面。30%的美国人都在使用电动刷，它有可能改善口腔健康，因为刷毛的快速运动可以更有效地清除刷毛够得着的牙菌斑，刷毛运动产生的微弱流体力可能会清除一些刷毛直接够不到的牙菌斑。然而，即使是最好的电动牙刷，也需要至少刷2分钟才能达到最佳效果（同时留下大量的近端间和牙龈下菌斑）。因此，开发一种能够在更短的刷牙时间（例如1分钟）内清除刷毛可及范围内和范围外的大部分牙菌斑的动力牙刷，可以为口腔健康提供重大进步——这是这个多阶段SBIR项目的目标。第一阶段的结果表明，一种动力牙刷的可行性，它结合了声波和超声波物理过程的新组合，可以快速、安全地去除牙菌斑，远远超过现有动力牙刷的能力。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，这种牙刷具有明确的制造潜力。这里提出的实质性II期工作的目的是：1)通过体外实验确定最佳牙菌斑清除和安全的超声和超声条件的选择；2)优化拟议牙刷的声学效率、可靠性和耐用性的设计；3)在人体临床研究中调查最终牙刷的有效性和安全性。研制出一种能在短时间内清除刷毛够及及不到的大部分牙菌斑的动力牙刷，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，第二行动伙伴将继续推行其商业计划，并将筹集开始生产和销售所需的私营部门资本。这款新产品将面向目前美国超过10亿美元、全球超过20亿美元的电动牙刷市场，并以每年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.