Development of QLF Handpiece for Early Caries Detection

产品说明：尽管在过去的25年中在美国观察到龋齿的患病率显著下降，但龋齿仍然是最常见的牙科疾病，并且需要用于预防和控制这种疾病的额外措施。在发展的早期阶段检测龋齿的能力将显著促进更有效的预防和控制这种疾病的措施的发展及其在牙科实践中的应用。用于龋齿检测的常规视觉-触觉-射线照相程序不能检测龋齿过程，直到它已经进展通过300-500微米的牙釉质，并且这种损伤难以用经常需要的修复程序逆转/消除。过去十年的研究表明，一种新技术，定量光荧光（QLF）不仅能够更早地检测龋齿过程，而且能够量化矿物质含量的变化，即，脱矿和矿化，因为它们发生在原位。这种能力将允许牙科医生：1）在空化之前识别反映龋齿风险的早期病变; 2）实施适当的干预措施，以更有效的结果在早期阶段逆转疾病过程;以及3）监测所应用的干预措施的成功（或失败）。然而，用于研究的QLF仪器是相当笨重的，并且对于临床牙科实践和临床研究中的常规使用是不可接受的。本阶段I申请建议重新设计QLF手柄，并进行必要的实验室确认测试，以确保继续检测极早期病变的能力。为了实现这些目标，一个工程师和牙科临床医生团队将重新设计和重建QLF系统的手机组件，以：a）减小其体积、重量和形状，以便于其在后牙上的使用，B）更换当前的镜子附件，以防止雾化并提高图像质量，c）提高照明水平，以防止阴影; d）替换/修改笨重的视频电缆和光导系统; e）增加获得白色光图像的能力;以及f）增加脱水系统以允许临床医生确定检测到的损伤的活性。然后将在实验室中评价所得原型手机，以验证其QLF检查的功能能力。

DESCRIPTION: 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.