SBIR-STTR Award

In spite of the remarkable decline in the prevalence of Dental caries observed in the U.S. during the past 25 years, Dental caries continues to be the most common Dental disease and additional measures for the prevention and control of this disease are needed. The ability to detect Dental caries at an earlier stage of development would markedly facilitate the development of more effective measures for the prevention and control of this disease and their use in Dental practice. Conventional visual-tactile-radiographic procedures for caries detection are unable to detect the caries process until it has progressed through 300-500 microns of enamel and such lesions are difficult to reverse/remineralize with restorative procedures frequently required. Research during the past decade has demonstrated that a new technology, Quantitative Light Fluorescence (QLF) is not only capable of detecting the caries process much earlier but is able to quantify changes in the mineral content, i.e., demineralization and remineralization, as they occur in situ. This capability will allow Dental practitioners to: 1) identify early lesions reflecting caries risk prior to cavitation; 2) implement appropriate interventions to reverse the disease process at an earlier stage with more efficient outcomes; and 3) monitor the success (or failure) of the applied intervention measures. Nevertheless, the QLF instrumentation used for research is quite cumbersome and unacceptable for routine use in clinical Dental practice and in clinical research. This Phase I application proposes to redesign the QLF handpiece and conduct the necessary laboratory validation tests to assure the continued ability to detect very early lesions. To achieve these goals a team of engineers and Dental clinicians will redesign and reconstruct the hand-piece component of the QLF system to: a) reduce its bulk, weight, and shape in order to facilitate its use on posterior teeth, b) replace the current mirror attachment to prevent fogging and improve image quality, c) improve the level of illumination to prevent shadows; d) replace/revise the cumbersome video cables and light guide system; e) add the capability of obtaining white light images; and f) add a dehydration system to permit the clinician to determine the activity of the detected lesions. The resultant prototype hand-piece will then be evaluated in the laboratory to verify its functional ability for QLF examinations

During the past 40 years there has been a remarkable decline in the prevalence of dental caries due to the widespread use of fluoride in public health programs, such as communal water fluoridation, dental practice and in oral hygiene products. In spite of this, dental caries continues to be the most prevalent dental disease. It is known that the traditional visual-tactile clinical caries examination procedure cannot detect lesions until they advance to the stage where they are difficult to reverse with fluorides and other measures. The understanding of the caries process has progressed far beyond the point of restricting the evidence for dental caries at the E2 (caries in enamel only) or D3 (caries in enamel and dentin) levels of cavitations. Recording lesions only at the cavitation level is no longer acceptable (ICCCT, 2002). Quantitative Light Fluorescence (QLF) is a technology that has been shown to detect and quantify the progress of lesions at an early stage (pre-cavitation). This technology will allow dental practitioners to: (a) identify early enamel demineralization reflecting caries risk prior to cavitation; (b) implement appropriate interventions to reverse the disease process at an earlier stage with more efficient outcomes; and (c) monitor the success or failure of the applied intervention measures. The overall goal of this program is to develop a QLF research system for use in clinical dental practice. The Phase I program successfully overcame the limitations of a research hand-piece to permit routine clinical use. The Phase 2 program seeks to further refine the instrument hardware and user software to make the technique practical within clinical practice. The specific aims of this application are to: (1) refine the instrument to make it more ergonomic and facilitate practical infection control procedures; (2) verify the ability of the redesigned instrument to detect early caries and monitor changes in a laboratory; (3) develop user-friendly computer software interfaces that are compatible with the existing software for use by dental professionals; (4) develop appropriate training materials; (5) verify efficacy of the system through a clinical investigation. The results of this research should improve dental health of the general population by identifying dental patients at greater risk of developing dental caries and result in the implementation of interventions to reverse the process and reduce or prevent the need for restorations