Biofilm infections are a major cause of mortality and morbidity. Dental caries occur as a result of an infectious disease in the oral cavity that is characterized by localized demineralization of susceptible tooth surfaces. The onset of dental caries results from the formation of an oral biofilm or plaque. Oral biofilm build-up is prevented using mechanical (brushing/flossing) and/or bactericidal treatments (tooth paste/mouth wash). However, for mobility-impaired patients, there are no effective alternative options for preventing or removing dental plaque. Consequently, dental caries in approximately 26 million geriatric patients has grown to epidemic proportions and is expected to worsen in the near future. The inability of geriatric patients to control dental plaque, the consequence of which is an increased incidence of root caries, adversely affects the patient's nutritional status, quality of life and increases the likelihood of tooth loss. Thus, there is an immediate need to develop alternative treatment options for dental care in mobility-impaired patients. One tested approach to treat oral biofilms is to employ enzymes that degrade the biofilms produced by the bacteria of the oral cavity. Previous attempts, however, proved ineffective due to poor retention of the enzymes in the mouth. To increase the retention time of biofilm degrading enzymes, our novel concept is to couple anchor domains to the plaque degrading enzymes to for an Anchor-Enzyme-Complex"""""""" (AEC""""""""). The anchors are designed to keep the enzymes within the oral cavity for a longer period of time. Our hypothesis is that enzymes engineered to have a higher affinity for the biofilm have a longer retention time and therefore are able to more effectively degrade the biofilms. Preliminary characterization of a prototype AEC"""""""" suggested that it has the requisite properties. The subject of this Phase I SBIR project is to further evaluate the prototype AEC using dynamic models of the oral cavity to establish the technical feasibility of employing this technology platform as a dental care product. Importantly, the results of the proposed experimental plan will provide the information needed to design effective clinical utility studies.
The proliferation of root caries in geriatric patients is an epidemic afflicting almost 26 million people over the age of 65. The inability of some geriatric patients to control dental plaque due to impaired mobility has resulted in an increased incidence of root caries which adversely affects the patient's nutritional status, quality of life and increases the likelihood of tooth loss. As there are no oral care products specifically designed for geriatric patients for either removing or preventing dental plaque, these patients represent an un-served medical need and market for an oral treatment to control plaque that results in root caries.