Reliability of caries data in three clinical trials

Area of Science:

• Dental Public Health
• Epidemiology
• Clinical Trials

Background:

• Assessing the reliability of caries data is crucial for the validity of clinical trials.
• Previous studies have highlighted variability in caries assessments.
• Standardized methods are needed to ensure consistent data collection in dental research.

Purpose of the Study:

• To evaluate the reliability of dental caries data collected across three distinct clinical trials.
• To quantify the impact of examiner variability and lesion type on data reliability.
• To measure the influence of data error on study efficiency and sample size estimation.

Main Methods:

• Three independent 3-year clinical trials involving 12-15 year olds were analyzed.
• Caries data reliability was quantified using reliability coefficients and error variance.
• The impact of including precocious (initial) lesions and different surface types on DMFS (decayed, missing, and filled surfaces) counts was examined.

Main Results:

• Reliability coefficients tended to decrease when initial caries lesions were included in the DMFS count.
• Minimal differences in reliability were observed across four different tooth surface types.
• Error had a greater impact on 3-year incremental caries data compared to prevalence data.

Conclusions:

• While including initial lesions can reduce caries data reliability, the impact on overall study efficiency is relatively small.
• Examiner and surface type variations have limited influence on the reliability of DMFS data.
• The findings support the robustness of caries data in clinical trials despite potential sources of error.