ASTM E2545-07(2012)

The color of gingiva or changes in gingival color can be observed. The light reflected from the facial surfaces of the gingiva can be used to calculate color coordinates. These data reveal information about the efficacy of a product, treatment studied, or epidemiology of anti-gingivitis treatments. For example, clinical studies of gingivitis treatment systems evaluate the efficacy of manufacturers' products.

The change in color of the facial surface gingiva can be used to determine and optimize the efficacy of anti-gingivitis treatments. For example, the data can provide the answer to the question: “What product or system is the most efficacious in the treatment of gingivitis?”

Chronic inflammatory disease of the gingiva and periodontium results in destruction of gingival connective tissue, periodontal ligament, and alveolar bone. Clinically, inflammation is seen as redness, swelling, and bleeding observed upon probing.

This procedure is suitable for use in diagnosis and monitoring, research and development, epidemiological or other surveys, marketing studies, comparative product analysis, and clinical trials.

Popular methods assess gingival inflammation via repeated clinical examination of the gingival tissues. ^, These methods typically quantify gingival color, which are used to assess gingival health or disease, at multiple intraoral sites on the gingiva using a simple non-linear scoring system or index. Assessment of gingival color is an important component of health status for mild-to-severe gingival disease. These techniques are time-consuming, subjective, and often invasive, and for archival purposes, separate intraoral photographs must be collected to document gingival color and appearance. Variation between and among examiners may contribute to appreciable differences in measurement.

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.