The advantages and disadvantages of running a clinical trial in general practices

Abstract

This paper reviews the experiences encountered in running a clinical trial on the use of a metal reinforced glass-ionomer cement in general dental practices. The practitioners were asked to place both the test material and amalgam in the same patient and to take impressions both at placement and at three recall intervals. Subsequently plaster casts were produced from these impressions. These were then assessed by three independent observers to provide evaluation of the relative wear of the two restoratives under evaluation. A commercial laboratory manufactured the models on which the three independent observers carried out the assessment of wear. Although the practitioners indicated they would be able to provide the number of restorations required in a relatively short period these expected numbers were never achieved. Despite recruitment of additional participants the trial never did achieve the number of restorations required. The performance of the metal reinforced glass ionomer appeared to vary dependent on the practitioner placing the filling. Questioning of the participants found that some participants were finishing the material using a method specifically contraindicated in the protocol for the trial, the directions supplied with the product, and in briefing sessions held prior to the trial. This implies that there can be major problems in undertaking clinical trials of this nature in the general dental service and has serious clinical implications for those contemplating this type of evaluation and for manufacturers introducing new products.