The prevalence of caries and the number and species distribution of salivary mutans streptococci in 356 children (aged 0-2 yr old) in Japan were examined twice at an interval of 1 yr. No mutans streptococci were isolated from the predentate children. The detection rate of mutans streptococci and the prevalence of caries increased with age. Mutans streptococci were isolated from 39.9% of the subjects. The majority of isolates were identified as Streptococcus mutans. The concentration of mutans streptococci correlated with the number of erupted teeth (r = 0.339). In addition, the concentration of mutans streptococci was more closely correlated to the caries prevalence of the next year (r = 0.465) than that of the year when the salivary concentration of mutans streptococci was first evaluated (r = 0.368). The children who had no caries but harbored mutans streptococci in the first year showed significantly higher caries prevalence in the next year than did the children with neither caries nor mutans streptococci. These results indicate that the establishment of mutans streptococci is associated with caries initiation in early childhood.