A Re-analysis of a Caries Clinical Trial by Survival Analysis

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Abstract
The decline in caries prevalence, the increases in the level of fluoride exposure, and the lack of placebo control subjects have complicated caries clinical trials in recent times. There has been a substantial increase in the numbers of subjects required for the detection of statistically significant differences between dental products, and hence, the cost of these trials has grown enormously. This study uses a new statistical approach to the analysis of the data from these trials with the ultimate aim of providing a more sensitive method of analysis. The new approach uses survival analysis, where the outcome measure is the survival time of an individual tooth surface. It exploits recent developments in the analysis of clustered survival data where survival times within the same cluster or subject are correlated. To illustrate, the new method of analysis was used for the North Wales, UK, caries clinical trial. It is concluded that survival analysis uses most of the data available in a caries clinical trial, an outcome measure that is easily understood and may lead to a more sensitive method of analysis.