Outcomes
carious lesions, Caries, caries, tooth, arrest
ARRESTED, CARIES, CARIES, DECAY, ARREST, DECAYED TEETH
At each observation, standardized study clinicians performed full-mouth visual-tactile oral examinations. Teeth were assessed as being present or missing intraorally. Caries diagnosis was performed using the standard International Caries Detection and Assessment System (ICDAS II) adapted criteria for epidemiology and clinical research settings.Our primary outcomes were the proportion of children with arrested carious lesions (arrest) and the proportion of children with no cumulative incidence of decayed teeth from previously sound dentition (prevention). Arrest failure was recorded if the tooth presented at baseline with untreated caries, received treatment at baseline with either experimental treatment or standard of care, and presented at follow-up with either untreated caries or a filling (indicative of treatment for caries applied by an external clinician). If a tooth was exfoliated prior to the 2-year follow-up that was coded as arrested after baseline treatment, that tooth was discounted from analysis. Caries prevention compared the cumulative incidence of caries in each treatment group. Children with new caries included those who presented at follow-up with either (1) untreated carious lesions or (2) presence of a filling not present at baseline. The decay determination was previously used in assessing the effectiveness of the active comparator.Outcomes were aggregated at the individual level to mitigate within-individual correlation for participants having multiple lesions at baseline or multiple new caries at follow-up. If a child at baseline presented with multiple carious lesions that received treatment, a failure of any treated lesion at follow-up was considered person-level arrest failure regardless of the status of other lesions. Similarly, caries incidence was considered prevention failure regardless of how many lesions were observed.Other outcomes of the CariedAway trial not reported here include the 4-year prevention rate of caries, the noninferiority of registered nurses vs dental hygienists in the effectiveness of treatment with SDF,