Normative Approaches for Oral Health: Standards, Specifications, and Guidelines.

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Abstract

Normative approaches have been developed with the aim of providing high-quality methods and strict criteria that, when applied correctly, lead to reliable results. Standards, specifications, and guidelines are needed to facilitate exchange of goods or information and secure comparability of data derived from different laboratories and sources. They are available along the whole flow from study development to test selection, study conduct, and reporting and are widely used for the evaluation of medical devices, market approval, and harmonization of terms and devices. Standards are developed by specific national and international organizations or by dedicated interest groups, mainly scientists in their respective fields. ISO (International Organization for Standardization) standards are developed following stringent regulations, and groups of experts formulate such standards. They should come from different areas (multistakeholder approach) to have as much and as broad input as possible and to avoid single-interest dominance. However, the presence of academia in such groups has been comparatively low. There is a clear need and responsibility of the oral health community to participate in the development of normative documents to provide methodological knowledge and experience, balance the interests of other stakeholders, and finally improve oral health. This will help to ensure that rapidly advancing fields of research, such as the oral health impacts of COVID-19 or the application of artificial intelligence in dentistry, benefit from standardization of approaches and reporting.