Efficiency in clinical trials of caries preventive agents and methods
Community Dentistry and Oral Epidemiology 4(5): 190-194
ISSN/ISBN: 0301-5661 PMID: 786538 DOI: 10.1111/j.1600-0528.1976.tb00982.x
The ideal sequence of tests required to establish a caries prophylactic agent or procedure on a public health basis is described, and a clear distinction is drawn between an experimental clinical trial, carried out under ideal conditions, and a community clinical trial, carried out under real life conditions. Because of the artificial nature of an experimental clinical trial there are strict limitations placed on its objectives and the inferences that can be drawn from its results. Bearing these limitations in mind and using the data collected during a 3 yr trial of a fluoride mouthrinse, 2 methods of improving the efficiency of experimental clinical trials of caries prophylactic agents are considered. A reduction in length is suggested by planning the trial to run for a shorter period in the first place or, alternatively, by stopping the trial when the criteria for success have been satisfied. The number of subjects participating in the trial may be reduced by excluding those whose contributions to the aims of the trial are likely to be low.