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Purpose: To compare the effectiveness of two 5% sodium fluoride (NaF) varnishes containing casein phosphopeptide amorphous calcium phosphate (CPP-ACP) or tricalcium phosphate (TCP) to the conventional 5% NaF varnish in preventing early childhood caries (ECC) in high caries-risk preschool children.

Methods: A double-blinded, randomized controlled trial recruited healthy 3–4 years old children having at least one carious lesion (pre-cavitated or cavitated) after obtaining written informed consent and a complete questionnaire from parents. Children were randomly assigned to one of the 3 groups: Control group (N=196): 5% NaF varnish (Duraphat) or the two test groups: 5% NaF with TCP (Clinpro White) (N=193) and 5% NaF varnish with CPP-ACP (MI Varnish) (N=193) to receive a quarterly application over the 24-month follow-up. The incidence and increment of both cavitated and non-cavitated carious lesions were measured using Independent-Samples Kruskal-Wallis Test. Zero-inflated negative binomial (ZINB) model was used to analyse the association between caries increment and selected independent variables at P < 0.05.

Results: Among 582 children recruited from 25 kindergartens, 381 completed the study at 24 months. No significant difference was found for the incidence and increment of cavitated and non-cavitated carious lesions among the 3 intervention groups. No significant association was found between the number of fluoride applications and caries increment. The final ZINB model consisting of zero-inflated and negative-binomial parts found no variable significantly associated with caries increment (P > 0.05 …