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

描述（由申请人提供）：尽管龋病的流行率显著下降，但龋病仍然是我们这个时代最普遍的疾病之一。然而，我们对疾病的自然史了解有限，无法准确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，结合现有的仪器成像技术，能够量化病变严重程度的变化，可能允许更小、更短的临床试验。以往研究表明，定量光诱导荧光（Quantitative Light Induced Fluorescence， QLF）成像技术对早期龋病的检测灵敏度高，但特异性较低，而新的视觉标准国际龋病检测与评估系统（ICDAS）具有较高的特异性。为了在不丧失特异性的情况下获得高灵敏度，我们建议将QLF检查与ICDAS标准相结合。预计一旦达到ICDAS/QLF评分和/或QLF参数的一定值，它将成为传统空化措施的可靠替代品。对于近牙病变的检测，一种新的红外荧光装置诊断笔，重新设计用于近牙病变的检测，将与ICDAS结合进行评估。本研究的主要目的是通过前瞻性纵向研究设计来确定ICDAS和QLF的结合是否可以在早期发现龋齿病变，并将其作为传统空化措施的替代品。为了进行这项研究，我们建议招募未来有龋齿风险的儿童，并使用临床终点（空化）对他们进行为期4年的随访。本研究的具体目的是：1)通过对一组高危儿童4年以上的龋齿自然病史的跟踪研究，确定用早期非空泡性龋齿病变代替真正临床终点空泡性龋齿病变的可行性；2)结合视觉标准（ICDAS）和QLF检查确定早期龋病是否可以作为空化病变的替代；3)确定ICDAS与改进型诊断笔联合识别的近似早期病变是否可以作为影像学上明显病变的替代。这种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，以推进该领域并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.