Clustering effects of oral conditions based on clinical and radiographic examinations.

Objectives: The intra-class correlation coefficient (ICC) is a measure of intra-subject clustering effects. A priori estimates of the ICC and the associated design effect (DE) are required for sample size estimation in clustered studies, and should be considered during their analysis, too. We aimed to determine the clustering effects of carious lesions, apical lesions, periodontal bone loss, and periodontal pocketing, assessed in clinical or radiographic examinations.

Methods: A subsample of patients (n = 175) enrolled in the fifth German Oral Health Study provided data on clinically determined carious teeth (i.e., with untreated carious lesions, WHO method) as well as teeth with periodontal pocketing (i.e., with maximum probing-pocket-depths ≥ 4 mm). A sample of panoramic radiographs (n = 85) from randomly chosen patients, examined from 2010 to 2017 at the Charité dental hospital, provided data on radiographically determined carious teeth (i.e., with lesions extending into dentine or enamel), teeth with apical lesions (determined by dentists via majority vote), and teeth with periodontal bone loss (≥ 20% of root-length). The ICC and its 95% confidence interval (95% CI) were determined.

Results: There were 3839 and 1961 teeth assessed in clinical and radiographic evaluations, respectively. For clinically or radiographically determined carious lesions, the ICC (95% CI) was 0.20 (0.16-0.24) or 0.19 (0.14-0.25), respectively. For clinical pocketing or radiographic bone loss, the ICC was 0.40 (0.35-0.46) or 0.30 (0.24-0.38), respectively. The lowest ICC was found for apical lesions at 0.08 (0.06-0.13).

Conclusions: The ICC varied between assessment methods and conditions. Clustered trials should account for this during study planning and data analysis.

Clinical Relevance: Within the limitations of this study, and considering the risk of selection bias and the limited sample sizes of both datasets, clustering effects were substantial but varied between dental conditions. Studies not accounting for this during planning and analysis may yield misleading estimates if clustering is present.