Kaufman H W, Kleinberg I
Department of Oral Biology and Pathology, School of Dental Medicine, SUNY at Stony Brook 11794-8702.
Arch Oral Biol. 1994;39 Suppl:97S-100S. doi: 10.1016/0003-9969(94)90194-5.
This paper discusses the design of clinical trials for testing the efficacy of therapeutic products for hypersensitive teeth with emphasis on statistical considerations. The preparation of a proper protocol is essential to the successful outcome of any clinical study. Key considerations in this regard are the criteria for patient selection, the size of the sample, the method of stratification of subjects into various test and control groups, the methods to be used for assessing sensitivity, and the statistical treatment of the data generated. The importance of other factors such as the requirement for a quiet, relaxed atmosphere and allowing adequate time for the examiner to establish a rapport with the subject, and the need to comply with institutional review board regulations, are stressed.
