Certification and acceptance programs for dental materials, instruments, and equipment. Council on Dental Materials, Instruments, and Equipment.
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SCOPE: These Guidelines apply to the design of clinical trials to evaluate products and methods which are intended to be used for the detection and diagnosis of periodontitis. The general purpose for such products and methods would be to assist in the identification of sites or subjects with existing periodontitis or, at increased risk of periodontitis, or for the development or progression of periodontitis. Clinical use of such diagnostics might occur: 1) during initial evaluation (screening, pre-treatment risk assessment, diagnosis, treatment-planning); 2) during treatment or management (monitoring therapeutic endpoints, identifying therapeutic targets); and 3) post-treatment (establishment of recall intervals, early detection of recurrent disease). The specifics of clinical trial design for each of these related, but separate, clinical functions may differ depending on a variety of circumstances.
SCOPE: These Guidelines apply to products used to slow or arrest periodontitis. The periodontal diseases represent a wide array of infections characterized by variable microbial clusters and host susceptibility factors that may require different therapeutic approaches. There are two basic ways to control periodontitis: 1) target the putative microbial components with anti-infective strategies; or 2) strengthen or suppress the host response with host modulation agents. Products that are designed for the prevention and/or control of gingivitis are addressed elsewhere and are not considered in these guidelines.
SCOPE: These Guidelines apply to products used to promote the regeneration of periodontal tissues lost due to periodontal diseases or other causes. Periodontal regeneration is defined histologically as regeneration of the tooth's supporting tissues, including alveolar bone, periodontal ligament, and cementum over a previously diseased root surface. Regenerative procedures must enhance the formation of a new attachment apparatus demonstrated by randomized controlled histological studies in animals, verified by human histologic evidence, and supported by beneficial results in human randomized controlled clinical trials.
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