Principles and pitfalls of clinical trials design.

Periodontitis and gingivitis trials can involve many complex experimental designs. The selection of a specific design and the details of the protocol can influence the magnitude of any effect observed, the generalizability of the results, and the clinical significance of the findings. The purpose of this paper is to review selected aspects of clinical trials including the overall clinical experimental design, controls, outcomes, sample size, and patient selection. Particular emphasis will be placed on periodontitis trials.