SBIR-STTR Award

A primary advance in personal oral health care has been the manual toothbrush, which allows the individual to take daily care of their oral hygiene. However, user compliance with twice-daily brushing is a perennial problem, with the average user spending little more than 40 seconds cleaning their teeth, with demonstrable poor oral health, simply because the user does not brush long enough to remove the plaque that can be reached by the bristles. Power brushes, used by 25% of people in the United States, have offered the potential for a significant advance in self-care, because those brushes (1) can efficiently remove plaque they can reach relative to manual brushes and (2) can remove some of the 50% of total plaque in the mouth that is beyond the reach of their bristles, plaque that is unreachable by manual brushes. Problems remain, however. Many of these power toothbrushes require two minutes of brushing to achieve these effects - a complaint of many users that results in reduced user compliance. And, a significant amount of plaque still remains after brushing with even the leading power toothbrushes. Therefore, the development of a power brush capable of removing the majority plaque both within reach of and beyond the reach of the bristles over a period of time sufficiently short (e.g., 1 minute) to meaningfully enhance patient compliance would mark a significant advance in oral health. Preliminary results obtained in vitro support the possibility of creating such a toothbrush. It has been shown that sonically induced, macroscopic fluid motion in the form of a bubbly jet generated by a mechanically altered toothbrush can rapidly and effectively remove plaque beyond the reach of the bristles. Additionally, bubbles stimulated with low levels of ultrasound can also rapidly remove plaque beyond the reach of the bristles, as can the combination of these physical processes. The purpose of this proposal is to study the effect of novel sonic and ultrasound-based physical processes on plaque while demonstrating the potential utility and feasibility of a power toothbrush with these processes.

Thesaurus Terms:
dental plaque, disease /disorder prevention /control, energy source, physical process, preventive dentistry, technology /technique development, tooth brushing, ultrasound consumer product, dental caries, dentifrice, oral health

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