Epidemiological investigations of early childhood oral health rely upon the collection of high-quality clinical measures of health and disease. However, ascertainment of valid and accurate clinical measures presents unique challenges among young, preschool-age children. The paper presents a clinical research protocol for the conduct of oral epidemiological examinations among children, implemented in ZOE 2.0, a large-scale population-based genetic epidemiologic study of early childhood caries (ECC). The protocol has been developed for the collection of information on tooth surface-level dental caries experience and tooth-level developmental defects of the enamel in the primary dentition. Dental caries experience is recorded using visual criteria modified from the International Caries Detection and Assessment System (ICDAS), and measurement of developmental defects is based upon the modified Clarkson and O'Mullane Developmental Defects of the Enamel Index. After a dental prophylaxis (toothbrushing among all children and flossing as needed), children's teeth are examined by trained and calibrated examiners in community locations, using portable dental equipment, compressed air, and uniform artificial light and magnification conditions. Data are entered directly onto a computer using a custom Microsoft Access-based data entry application. The ZOE 2.0 clinical protocol has been implemented successfully for the conduct of over 6000 research examinations to date, contributing phenotype data to downstream genomics and other "omics" studies of ECC and DDE, as well as traditional clinical and epidemiologic dental research.
Keywords: Caries diagnosis; Children; Clinical research; Dental caries; Developmental defects of the enamel; Early childhood caries; Protocol.