Randomized Clinical Trial of the Effect of Prenatal Fluoride Supplements in Preventing Dental Caries

Abstract

This randomized, double-blind study tested the caries-preventive efficacy of prenatal fluoride supplementation in 798 children followed until age 5. Initially, 1,400 women in the first trimester of pregnancy residing in communities served by fluoride-deficient drinking water were randomly assigned to one of two groups. During the last 6 months of pregnancy the treatment group received 1 mg fluoride daily in the form of a tablet and the control group received a placebo. Both treatment and control subjects were encouraged to use postnatal dietary fluoride supplements. Caries was measured in children at ages 3 and 5 while fluorosis was assessed at age 5. Caries activity was very low in both study groups: 92% of children remained caries-free in the treatment group and 91% remained caries-free in the placebo group. Fluorosis was observed in 26 subjects, all classified as very mild. Overall, there were no statistically significant differences in the study groups with respect to caries and fluorosis in deciduous teeth. The study had sufficient power to detect an absolute risk reduction of 5.1% while only a 1.5% reduction was observed. These findings do not support the hypothesis that prenatal fluoride has a strong caries-preventive effect.

Systemic versus Topical Fluoride

“…Primary teeth were protected against caries even though prenatal incorporation of fluoride into unerupted teeth was insignificant. Additionally, a randomized, doubleblind, longitudinal study testing the caries-preventing efficacy of prenatal fluoride supplementation in children followed until age 5 failed to support the hypothesis that prenatal fluoride has a strong caries-preventive effect [Leverett et al, 1997]. Hellwig and Klimek [1985] found that children 12.5-16 years old who had been exposed all their life to naturally fluoridated water exhibited significantly fewer carious lesions compared to a control group.…”

Conhecimento sobre uso de fluoretos em saúde bucal coletiva entre coordenadores municipais de saúde bucal do Estado de Santa Catarina, Brasil

“…30 Suplementos de flúor, como medicamentos, são de prescrição individual, sem efetividade como medida de Saúde Pública.…”

Fluoride Concentrations in Enamel and Dentin of Primary Teeth after Pre- and Postnatal Fluoride Exposure

“…More recently, a clinical trial [Leverett et al, 1997] on prenatal fl uoride supplements did not demonstrate a correlation between prenatal fl uoride exposure and caries experience of the sample studied. In the present study fl uoride concentrations were analyzed in enamel and den-…”

“…Primary teeth were collected from a randomized, double-blind study of prenatal fl uoride supplementation in 798 children followed until age 5 [Leverett et al, 1997]. During the duration of the study parents were encouraged to mail in their children's primary teeth as they exfoliated, in envelopes previously provided by the study committee.…”

“…In the present study fl uoride concentrations were analyzed in enamel and den- tin of deciduous teeth from the two groups studied by Leverett et al [1997], to test the hypothesis that prenatal fl uoride supplementation signifi cantly increases fl uoride concentration in dental tissues.…”