Efficacy of 1.23% APF gel applications on incipient carious lesions: a double-blind randomized clinical trial

The aim of this double-blind randomized clinical trial was to evaluate the efficacy of 1.23% APF gel application on the arrest of active incipient carious lesions in children. Sixty 7- to 12-year-old children, with active incipient lesions were included in the study. Children were divided randomly into 2 groups: 1.23% APF gel and placebo gel applications. Each group received 8 weekly applications of treatment. The lesions were re-evaluated at the 4th and 8th appointments. Poisson regression analysis was used to estimate relative risks of the presence of active white spot lesions. Groups showed similar results (PR = 1.67; CI 95% 0.69–3.98). The persistence of at least 1 active lesion was associated with a higher number of lesions in the baseline (PR = 2.67; CI 95% 1.19–6.03), but not with sugar intake (PR = 1.06; CI 95% 0.56–2.86) and previous exposure to fluoride dentifrice (PR = 1.26; CI 95% 0.49–2.29). The trial demonstrates the equivalence of the treatments. The use of the APF gel showed no additional benefits in this sample of children exposed to fluoridated water and dentifrice. The professional dental plaque removal in both groups may also account for the resulting equivalence of the treatments.