Clinical Validation of Combined ICDAS/QLF Exam for Early Caries Detection

描述(申请人提供)：尽管龋齿患病率显著下降，但龋齿仍然是我们这个时代最常见的疾病之一。然而，我们对这种疾病的自然病史了解有限，无法准确和客观地识别早期病变和/或正在积极进展的病变。使用创新的视觉龋齿标准，结合现有的能够量化病变严重程度变化的仪器成像技术，可能会允许进行更小和更短的临床试验。以往的研究表明，定量光诱导荧光(QLF)是一种成像技术，对早期龋损的检测具有较高的敏感性但特异性较低，而国际龋病检测与评估系统(ICDAS)作为一种新的视觉标准具有较高的特异性。为了在不损失特异性的情况下获得高敏感性，我们建议将QLF检查与ICDAS标准相结合。预计一旦ICDAS/QLF评分和/或QLF参数达到一定的值，它将成为传统空化措施的可靠替代品。为了检测邻近的病变，将结合ICDAS对重新设计的用于检测邻近龋齿的新的红外荧光设备--诊断笔进行评估。这项研究的主要目标是采用前瞻性纵向研究设计，确定ICDAS和QLF联合使用是否可以在早期阶段发现龋损，并将其用作传统空化措施的替代品。为了实现这项研究，我们建议招募未来有龋齿高风险的儿童，并使用临床终点(空化)对他们进行为期4年的跟踪。本研究的具体目的是：1)通过跟踪一组高危儿童长达四年的龋齿自然病史，确定使用早期非空洞龋损替代真正的临床终点空洞病变的可行性；2)确定联合视觉标准(ICDAS)和QLF检查确定的早期龋损是否可用作空洞病变的替代品；以及3)确定ICDAS和改良的诊断笔相结合识别的接近早期的龋损是否可用作放射学明显病变的替代品。这一早期龋齿检测方法的成功验证将为临床医生和研究人员提供必要的工具，以推进这一领域的发展，减轻人类面临的最常见疾病的负担。

DESCRIPTION (provided by applicant): Despite the significant decline in caries prevalence, caries remain one of the most prevalent diseases of our times. However, we have only limited understanding of the natural history of the disease and are unable to accurately and objectively identify early lesions and/or lesions that are actively progressing. The use of innovative visual caries criteria in combination with available instrumental imaging technologies capable of quantifying changes in the severity of the lesions may permit smaller and shorter clinical trials. Previous studies have indicated that Quantitative Light Induced Fluorescence (QLF), an imaging technique, has high sensitivity but low specificity for detection of the early stages of caries lesions while a new visual criteria, the International Caries Detection and Assessment System (ICDAS) has high specificity. To achieve high sensitivity without loss of specificity we propose to combine the QLF exam with the ICDAS criteria. It is anticipated that once a certain value for the ICDAS/QLF score and/or QLF parameters is reached, it will be a reliable surrogate for traditional cavitation measures. For detection of approximal lesions a new infrared fluorescence device, DIAGNOdent pen, redesigned for the detection of approximal caries will be evaluated in combination with ICDAS. The primary goal of this investigation is to determine, using a prospective longitudinal study design, if a combination of ICDAS and QLF, can detect carious lesions at an early stage and use them as surrogates for traditional cavitation measures. To enable this research we propose to enroll children at high-risk of future caries and follow them for 4 years using a clinical end point (cavitation). The Specific Aims of this study are to: 1) Establish, the feasibility of using early non-cavitated caries lesions as surrogate for the true clinical endpoint, cavitated lesions, by following the natural history of dental caries in a group of high-risk children over a four year period; 2) Determine if early dental caries lesions as identified by a combination of visual criteria (ICDAS) and QLF exam can be used as a surrogate for cavitated lesions; and 3) To determine if approximal early lesions as identified by a combination of ICDAS and a modified DIAGNOdent pen can be used as a surrogate for radiographically evident lesions. The successful validation of this early caries detection approach will provide the tools necessary for clinicians and researchers to advance the field and reduce the burden of the most common disease facing mankind.