Description

1.1 This test method covers the procedure, instrumental requirements, standardization procedures, material standards, measurement procedures, and parameters necessary to make precise measurements of gingival color. In particular it is meant to measure the color of gingiva in human subjects.

1.2 Digital images are used to evaluate gingival color on the facial labial or buccal surfaces of the gingiva. The marginal gingival tissue adjacent to natural teeth may be of particular interest for 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. All localized discoloration; such as stains, inclusions, pigmentations, etc., may be separated from the measurement and the analysis.

1.2.1 The broadband reflectance factors of gingiva and the surrounding tissue are measured. The colorimetric measurement is performed using an illuminator(s) that provides controlled illumination on the gingiva using a digital still camera to capture the digital image.

1.3 Data acquired using this test method may be used to assess personal gingival color 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 gingival color, health and disease among populations in epidemiological surveys, evaluation of comparative product efficacy, or safety and treatment response in clinical trials involving gingival health or disease.

1.4 The apparatus, measurement procedure, and data analysis technique are generic, so that a specific apparatus, measurement procedure, or data analysis technique may not be excluded.

1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

1.6 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.