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作废 ASTM E2670-15
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Standard Test Method for Objective Quantification of Dental Plaque Using Digital Still Cameras (Withdrawn 2018) 使用数码相机对牙斑进行客观定量的标准测试方法
发布日期: 2015-07-01
废止日期: 2018-05-04
1.1 该方法涵盖了精确测量荧光显示的牙齿上的牙菌斑所需的程序、仪器要求、标准化程序、材料标准、测量程序和参数。特别是,它旨在测量人类牙齿上的菌斑数量和菌斑覆盖率。 1.2 数字图像用于使用判别分析测量牙齿上牙菌斑的覆盖率。所有局部变色,如污渍、夹杂物、色素沉着等,可从测量和分析中分离出来。所有其他非相关部分,如牙齿、舌头、间隙、牙齿修复或假牙等,必须与测量和分析分开。 注1: 本程序可能不适用于所有类型的牙科工作。 1.3 测量了牙齿和周围组织的宽带反射系数。 使用照明系统进行色度测量,该照明系统在牙齿和周围组织上提供受控照明。数码相机(DSC)用于捕捉数字图像。 1.4 使用该方法获得的数据可用于评估个人牙菌斑覆盖率,以确定整体健康状况、口腔特定部位的健康状况,或跟踪个人健康状况随时间的变化。汇集的数据可用于在流行病学调查中评估人群中的斑块覆盖率、健康、疾病、比较产品疗效的评估,或在涉及斑块覆盖率或疾病的临床试验中的安全性和治疗反应。 1.5 本文描述的设备、测量程序和分析技术是通用的。目的不是排除特定的仪器、测量程序或分析技术。 1.6 以国际单位制表示的数值应视为标准值。括号中的值仅供参考。 1.7 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全和健康实践,并确定监管限制的适用性。 ====意义和用途====== 5.1 牙齿反射的光和牙齿上斑块发出的光由DSC捕捉。从图像中提取的数字数据可用于识别和分类像素。随着时间的推移,可以观察到斑块覆盖率的变化。一个例子是牙刷清除牙菌斑功效的临床研究。 5.2 评估牙齿上牙菌斑的数量和覆盖率可用于优化旨在减少牙菌斑覆盖率的产品和程序的设计。 5.3 临床评估,例如,改良的Turesky斑块指数, 5. , 6. 是一种主观的、非线性的、基于整数的量表,可能需要广泛的考官培训和重新认证。与其他方法相比,本文所述方法提供了更高的精度、重复性和再现性。 5.4 该程序适用于研发、营销声明和广告、比较产品分析和临床试验。
1.1 This method covers the procedure, instrumental requirements, standardization procedures, material standards, measurement procedures, and parameters necessary to make precise measurements of dental plaque on the teeth revealed by fluorescence. In particular it is meant to measure the amount of plaque and plaque coverage on human teeth. 1.2 Digital images are used to measure the coverage of dental plaque on the teeth using discrimination analysis. All localized discoloration, such as stains, inclusions, pigmentations, etc., may be separated from the measurement and the analysis. All other non-relevant parts, such as teeth, tongue, spaces, dental restorations or prostheses, etc., must be separated from the measurement and the analysis. Note 1: This procedure may not be applicable for all types of dental work. 1.3 The broadband reflectance factors of the teeth and surrounding tissue are measured. The colorimetric measurement is performed using an illuminator system that provides controlled illumination on the teeth and surrounding tissue. A Digital Still Camera (DSC) is used to capture the digital image. 1.4 Data acquired using this method may be used to assess personal plaque coverage for the purposes of identifying overall health status, health status at specific sites in the mouth, or to track changes in personal health status for individuals over time. Pooled data may be used to assess plaque coverage, health, disease among populations in epidemiological surveys, evaluation of comparative product efficacy, or safety and treatment response in clinical trials involving plaque coverage or disease. 1.5 The apparatus, measurement procedure, and analysis technique described herein are generic. The intent is not to exclude a specific apparatus, measurement procedure, or analysis technique. 1.6 The values stated in SI units are to be regarded as standard. The values in parenthesis are for information only. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 5.1 The light reflected from the teeth and emitted from the plaque on the teeth is captured by a DSC. Digital data extracted from the images can be used to discriminate and classify pixels. Monitored over time, changes in plaque coverage can be observed. An example is a clinical study of the efficacy of tooth brushes to remove dental plaque. 5.2 Assessing the quantity and coverage of dental plaque on teeth can be used to optimize the design of products and procedures intended to reduce dental plaque coverage. 5.3 Clinical assessment, for example, the modified Turesky Plaque Index, 5 , 6 is a subjective, non- linear, integer based scale that may require extensive examiner training and recertification. The method described here provides increased precision, repeatability, and reproducibility in comparison to other methods. 5.4 This procedure is suitable for use in research and development, marketing claims and advertising, comparative product analysis, and clinical trials.
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归口单位: E12.06
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