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Acceptance Program Guidelines. Products and methods for the diagnosis and/or management of periodontitis. Council on Scientific Affairs. American Dental Association.

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.

Clinical Trials as Topic↗

Acceptance Program Guidelines. Chemotherapeutic agents to slow or arrest periodontitis. Council on Scientific Affairs. American Dental Association.

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.

Adjuvants, Immunologic↗

Acceptance Program Guidelines. Products designed to regenerate periodontal tissues. Council on Scientific Affairs. American Dental Association.

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.

Alveolar Process↗

Clinical methods for determining dentifrice-cleaning ability. American Dental Association Health Foundation Research Institute.

This collaborative study of dentifrice-cleaning methodology and function was conducted to compare three dental stain-grading methods among 300 adults who brushed their teeth for 8 weeks with three specially formulated calcium phosphate dentifrices, which differed in dentin abrasivity. In general, with some difference in sensitivity, use of the three stain-grading methods distinguished among different groups of the population using these three dentifrices. By using the method with the greater level of magnification, a significant difference was detected earlier. The data indicate that there is a linear correlation between dentin abrasivity as measured in vitro and observed clinical stain cleaning. As the dentifrices used in this study were custom-designed and limited to the chemical family of calcium ortho-phosphates, the linear relation between abrasivity and cleaning in this study cannot necessarily be related to other abrasive systems or other abrasion levels. Either of the two study designs, that is, testing after a prophylaxis (stain accumulation) or non-prophylaxis (stain removal), is appropriate for future investigations. However, in this study, greater examiner sensitivity was observed with the design that utilized preformed pellicle stain of known history as the substrate for cosmetic tooth-cleaning.

Adolescent↗