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

Author(s): Leverett DH, et al.
Journal: Caries Research
Volume (number): 31:174-179
Month, Year: 1997
Major topic: effect of prenatal fluoride supplements in preventing caries in the deciduous dentition
Minor topic(s): relationship between prenatal fluoride and fluorosis in children
Type of Article: clinical research article
Main Purpose: to test the hypothesis that prenatal fluoride supplementation reduced caries in children
Overview of method of research: randomized, double-blinded study; 1400 women in their first-trimester of pregnancy and living in fluoride deficient communities were randomly assigned to one of two groups: treatment and control. Fluoride-deficient was defined as less than 0.3 ppm. During the last 6 months of pregnancy, the treatment group received a 1 mg tablet of fluoride daily; during this same time period, the control group received a placebo tablet. The fluoride tablet contained 2.2 mg of sodium fluoride which yields 1 mg of active fluoride. All participants were provided with post-natal fluoride supplements. From birth until the 3rd birthday, the mothers dispensed the appropriate fluoride dosage to their children. Each child was examined at 3 years of age for DFS without radiographs. Each child was then examined at 5 years of age for DFS without radiographs. At this latter visit, the children were also examined for fluorosis. Compliance was measured using self-reported information and by recording when new supplements were requested. 20% of children were lost to follow-up b the time of the 3-year examination and an additional 15% were lost between the 3-year and 5-year examination periods.
Findings: Compliance during the prenatal period was found to be 88% adherence. There were no statistically significant differences between the two groups for caries status. Of the 798 children, 26 had mild fluorosis (using Dean’s score). The maxillary second molar was the tooth most commonly found with fluorosis. There was no statistically significant difference between the two groups for fluorosis.
Key points/Summary: prenatal fluoride does not have a strong caries-preventive effect on children; the authors do point out that the low levels of caries in both groups could be due to the high level of compliance in postnatal fluoride use.
Assessment of article: Well-constructed research article.