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: 7674190
• 负责人: ANDREA Goncalves Ferreira ZANDONA
• 金额: $ 2.71万
• 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 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7674190
• 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; 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）：尽管龋齿患病率显著下降，但龋齿仍然是我们这个时代最流行的疾病之一。然而，我们对疾病的自然史只有有限的了解，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，能够量化病变的严重程度的变化可能允许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），一种成像技术，具有较高的灵敏度，但特异性低，用于检测早期龋损，而一个新的视觉标准，国际龋检测和评估系统（ICDAS）具有较高的特异性。为了在不损失特异性的情况下获得高灵敏度，我们建议将QLF检查与ICDAS标准结合联合收割机。预期一旦达到ICDAS/QLF评分和/或QLF参数的特定值，其将是传统空化测量的可靠替代。对于邻面病变的检测，将结合ICDAS对一种新的红外荧光设备（DIAGNOdent笔）进行评价，该设备经过重新设计用于邻面龋齿的检测。本研究的主要目的是使用前瞻性纵向研究设计，确定ICDAS和QLF的组合是否可以在早期检测到龋损，并将其用作传统空化措施的替代品。为了使这项研究能够进行，我们建议招募未来龋齿高风险的儿童，并使用临床终点（空化）对他们进行4年的随访。本研究的具体目的是：1）通过对一组高危儿童龋齿的自然史进行为期四年的跟踪研究，确定使用早期非龋蚀病变作为真正的临床终点龋蚀病变替代物的可行性; 2）确定通过视觉标准（ICDAS）和QLF检查的组合识别的早期龋齿病变是否可以用作空洞病变的替代物;以及3）确定通过ICDAS和改良DIAGNOdent笔的组合识别的邻近早期病变是否可用作放射学上明显病变的替代物。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，以推动该领域的发展，并减轻人类面临的最常见疾病的负担。