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

ICDAS/QLF 联合检查用于早期龋齿检测的临床验证

• 批准号: 7280801
• 负责人: ANDREA Goncalves Ferreira ZANDONA
• 金额: $ 63.37万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7280801
• 关键词: Age; Child; Clinical; Clinical Research; Clinical Trials; Computer software; Consensus Development Conferences; Data; Dental caries; Depth; Detection; Development; Devices; Diagnosis; Disease; Early Diagnosis; End Point; Enrollment; Evaluation; Fluorescence; Funding; Future; Goals; Image; Imaging Techniques; Imaging technology; International; Intervention; Investigation; Lasers; Lesion; Life; Light; Longitudinal Studies; Measures; Methods; Monitor; Natural History; Polarization Microscopy; Population Study; Prevalence; Preventive; Procedures; Rate; Research; Research Design; Research Personnel; Risk; Score; Sensitivity and Specificity; Severities; Specificity; Staging; Surface; Surrogate Endpoint; System; Techniques; Testing; Time; United States National Institutes of Health; Validation; Visual; Visual system structure; base; deciduous tooth; demineralization; disease natural history; fluorescence imaging; innovation; new technology; novel; novel strategies; permanent tooth; programs; prospective; size; tool; tooth surface; validation studies

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.

描述（由申请人提供）：尽管龋齿患病率显着下降，但龋齿仍然是当今时代最流行的疾病之一。然而，我们对该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。将创新的视觉龋齿标准与能够量化病变严重程度变化的现有仪器成像技术相结合，可以允许规模更小、时间更短的临床试验。以往的研究表明，定量光诱导荧光（QLF）这种成像技术对于早期龋病病变的检测灵敏度高，但特异性较低，而新的视觉标准——国际龋齿检测和评估系统（ICDAS）则具有较高的特异性。为了在不损失特异性的情况下实现高灵敏度，我们建议将 QLF 考试与 ICDAS 标准结合起来。预计一旦 ICDAS/QLF 评分和/或 QLF 参数达到一定值，它将成为传统空化测量的可靠替代品。为了检测邻近病变，将结合 ICDAS 结合评估一种新的红外荧光设备 DIAGNOdent pen，该设备重新设计用于检测邻近龋齿。这项调查的主要目标是使用前瞻性纵向研究设计来确定 ICDAS 和 QLF 的组合是否可以在早期阶段检测到龋齿并将其用作传统空化措施的替代品。为了开展这项研究，我们建议招募未来龋齿高风险的儿童，并使用临床终点（空洞）对他们进行为期 4 年的跟踪。本研究的具体目标是： 1) 通过跟踪一组高危儿童四年内的龋齿自然史，确定使用早期非空洞性龋齿病变作为真正的临床终点（空洞性病变）的替代方案的可行性； 2）确定通过视觉标准（ICDAS）和QLF检查相结合确定的早期龋齿病变是否可以用作空洞病变的替代； 3) 确定通过 ICDAS 和改进的 DIAGNOdent 笔组合识别的近似早期病变是否可以用作放射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，以推进该领域的发展并减轻人类面临的最常见疾病的负担。