Acceptance Program Guidelines: Products and Methods for the Diagnosis and/or Management of Periodontitis.

Abstract

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.