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Statistical issues for combining multiple caries diagnostics for demonstrating caries efficacy.
1Division of Biostatistics, Indiana University School of Medicine, 1050 Wishard Blvd, RG 4101, Indianapolis, IN 46260, USA. bkatz@iupui.edu
Journal of Dental Research
|August 3, 2004
Summary
This study compared methods for analyzing multiple dental caries diagnostic measures in clinical trials. All evaluated methods showed good performance, but ease of use and interpretability are key for selecting a consensus approach.
Area of Science:
- Dentistry
- Clinical Trials
- Diagnostic Methods
Background:
- Traditional caries diagnosis relies on visual exams, Fiber Optic Transillumination (FOTI), and radiography.
- Newer techniques offer quantitative, continuous caries measurements instead of ordinal classifications.
Purpose of the Study:
- To evaluate various analytical methods for multiple outcomes in dental caries clinical trials.
- To compare the utility of these methods using real-world trial data.
Main Methods:
- Analysis of one-year follow-up data from 1063 children in a caries trial.
- Evaluation of four global tests (rank sum, OLS, GLS, GEE) and two caries indices (average, maximum).
- Development and assessment of a novel hybrid analysis method.
Main Results:
- All tested analytical methods performed effectively when diagnostic measures indicated caries differences consistently.
- No single method emerged as universally superior without considering practical factors.
Conclusions:
- The choice of analytical method for multiple caries diagnostic measures requires consideration of ease of use, interpretability, and statistical assumptions.
- Further consensus is needed to establish a standardized approach for analyzing complex caries trial data.