Abstract

In 1966 the US Food and Drug Administration forbad advertisements claiming efficacy of prenatal fluoride supplements, due to lack of clinical data supporting such a claim. In the early 1980s, the NIDR funded a randomized clinical trial to address this issue. 1,400 women in the first trimester of pregnancy were recruited into the study and were randomly assigned to one of two groups — daily 1 mg fluoride tablet, daily placebo tablet — during the last six months of pregnancy. After birth all subjects, experimental and control, were encouraged to use postnatal dietary fluoride supplements in ADA-recommended dosage. Clinical examinations for dental caries were conducted when the offspring reached three years and five years of age. dfs in the experimental group was not significantly different from the placebo group at either the three-year or the five-year exam. However, there was a significant association between caries prevalence at the three-year exam and measured compliance with postnatal dietary fluoride ingestion during the first two years of life. Although the anticaries efficacy of prenatal fluorides was not demonstrated in this study, the extraordinarily low caries prevalence in both groups (91-92% caries free) may have obscured any possibility of demonstrating a beneficial effect.

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