DIFFERENTIAL-DIAGNOSIS IN CLINICAL-TRIALS OF THERAPY FOR PERIODONTITIS

For purposes of clinical trials of therapies for periodontitis, it is recommended that population samples be identified as adult periodontitis (systemically modified or not systemically modified), early onset periodontitis (localized or juvenile, generalized or rapidly progressive, or associated with systemic disease), or necrotizing ulcerative periodontitis, avoiding overlapping criteria. Population samples of adult or early onset periodontitis modified by or associated with systemic conditions should be used in clinical trials only when the intent is to study effect on the specifically modified condition. Objective identification of the modifying systemic condition should be required for all subjects in such trials. Population samples should be homogeneous for the diagnosis, whether systemically modified or not. Refractory periodontitis, prepubertal periodontitis, and periodontitis associated with systemic disease are not recommended as useful descriptors of population samples without discrete identification of underlying systemic abnormality for all included subjects. Definition of population sample by a bacteriological or a host response feature is not recommended unless the trial is specifically aimed at that feature and the sample is homogeneous for it. All trials of efficacy should include physical or radiographic measurement of attachment level or bone height as a critical outcome variable. Results from trial in one form of periodontitis should not be applied directly to other forms.