Statistical methodology for clinical trials of caries prophylactic agents--current knowledge

Area of Science:

• Dental research
• Biostatistics
• Clinical trial methodology

Background:

• Clinical trials for caries prophylactic agents rely on specific statistical methodologies.
• Caries indices and data models are crucial for evaluating preventive agents.
• Understanding statistical approaches is vital for interpreting trial outcomes.

Purpose of the Study:

• To summarize the statistical methodology used in clinical trials of caries prophylactic agents up to 1982.
• To review caries indices, data models, and statistical techniques employed in these trials.
• To discuss methods for improving the efficiency and analysis of such trials.

Main Methods:

• Review of statistical techniques applied to caries clinical trial data.
• Examination of caries indices and statistical models for prevalence and increment.
• Discussion of parametric statistical tests, sample size estimation, and multiple comparison tests.
• Consideration of analysis of covariance, stratification, and subject selection for trial efficiency.

Main Results:

• Parametric statistical techniques are robust for caries data, especially with large sample sizes.
• Examiner error in long-term trials is generally found to be small.
• Analysis of covariance and stratification can improve trial efficiency in specific situations.

Conclusions:

• Established statistical methods are largely appropriate for caries clinical trials.
• Further development is needed for the application of sequential tests in this field.
• The review provides a foundation for understanding statistical approaches in dental caries research.