Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being
Condition: Preterm Birth; Preterm Labor; Bacteremia; Preterm Premature Rupture of Fetal Membranes
MeSH terms: Bacteremia; Premature Birth; Obstetric Labor, Premature; Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether fluoride supplementation during pregnancy
      is effective in extending the length of gestation and improving overall perinatal well-being.
    

Detailed description: 
      The Centers for Disease Control and Prevention (CDC) reports that preterm birth affected
      about 1 in 10 infants born in the United States in 2015. These statistics emphasize the
      significance of implementing a safe and effective therapy into routine clinical care aimed at
      reducing the rate of preterm birth. There has been evidence to suggest that fluoride
      supplementation to women during pregnancy can provide other medical benefits, in addition to
      a reduction in dental caries.

      Fluoride is recognized by the Food and Nutrition Board (F&NB) of the American Academy of
      Sciences and the Food & Drug Administration (FDA) as an essential ion due to its association
      with a reduction in dental caries.

      Upon entering the body, fluoride is taken up into the bones/calcified tissues, and excreted
      by the kidneys. When supplied during pregnancy in small aliquots, as with water fluoridation,
      the fluoride is likely taken up in the mother's bones and excreted by her kidneys so rapidly,
      that the fetus is denied a meaningful amount of fluoride, unless it is supplied in a pulse
      dose by supplement. The Institute of Medicine's Food and Nutrition Board recommends 3 mg/day
      for Adequate Intake in pregnancy and deems 10 mg/day as the Upper Limit.

      After several papers elucidating an association between poor dentition, periodontal disease,
      and preterm birth, subsequent RCT's of regular periodontal scaling and treatment during
      pregnancy are still inconclusive in regards to preterm birth.

      The investigators hypothesize that fluoride supplementation during pregnancy may have a
      beneficial effect on the natural microbiome of the maternal oral cavity and genital tract,
      capable of protecting against transient bacteremia and ascending infection, respectively,
      which are known antecedents to both preterm labor and preterm premature rupture of membranes.
      The research team predicts that the testing and analysis of specimens collected will
      demonstrate microbiome changes toward a more favorable profile not associated with preterm
      birth.

      The proposed randomized, double-blinded, placebo-controlled clinical trial aims to confirm
      the efficacy of fluoride supplementation in pregnancy to extend length of gestation and
      increase overall perinatal well-being, and to confirm transplacental transfer of supplemental
      fluoride. This research may also identify other beneficial maternal and neonatal outcomes
      associated with the administration of fluoride during the perinatal period by attempting to
      characterize and compare the microbiomes of the maternal oral cavity and genital tracts
      between supplemented and unsupplemented gravidas.
    

Intervention name(s): Prenatal vitamin-mineral containing 3 mg fluoride; Prenatal vitamin-mineral containing 0 mg fluoride
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Prenatal vitamin-mineral containing 3 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.; Prenatal vitamin-mineral containing 0 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.
Intervention MeSH terms: Vitamins; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Fluoride Supplementation; Prenatal Vitamin; Pregnancy Nutrition; Prenatal Nutrition