Controlled clinical trials are conducted primarily in university settings under very closely managed conditions. This scenario imparts the necessary scientific rigor to ensure that results are attributable to the independent variables. It helps to ensure that the study outcomes provide accurate and precise information about a new treatment, material, or technique. These controlled clinical studies are most useful for determining the maximum potential of the treatment of interest.
However, clinical trials in the university setting do not duplicate how various procedures are performed in routine practice outside of this setting, and therefore do not provide information about the typical outcomes to be expected within a practice-based population of clinicians. This discrepancy can significantly affect conclusions regarding oral health care outcomes. The controlled clinical trials are very expensive, and typically too small to include enough members of varying populations. In addition, controlled clinical trials do not allow assessment of disease progression and treatment effects under the normal “in situ” conditions in which dentistry is routinely practiced.
Therefore, there is a need for practice-based clinical studies that can reach a large and diverse population, while maintaining an adequate level of control of the design and conduct of the study. This is the intent of PROH.