Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT02536352

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Preterm Labor Bacteremia Preterm Premature Rupture of Fetal Membranes	Drug: Prenatal vitamin-mineral containing 3 mg fluoride Dietary Supplement: Prenatal vitamin-mineral containing 0 mg fluoride	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluoride prenatal vitamin Prenatal vitamin-mineral containing 3 mg fluoride	Drug: Prenatal vitamin-mineral containing 3 mg fluoride Prenatal vitamin-mineral containing 3 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.
Active Comparator: Standard prenatal vitamin Prenatal vitamin-mineral containing 0 mg fluoride	Dietary Supplement: Prenatal vitamin-mineral containing 0 mg fluoride Prenatal vitamin-mineral containing 0 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.

Arm

Intervention/Treatment

Experimental: Fluoride prenatal vitamin

Prenatal vitamin-mineral containing 3 mg fluoride

Drug: Prenatal vitamin-mineral containing 3 mg fluoride

Prenatal vitamin-mineral containing 3 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.

Active Comparator: Standard prenatal vitamin

Prenatal vitamin-mineral containing 0 mg fluoride

Dietary Supplement: Prenatal vitamin-mineral containing 0 mg fluoride

Prenatal vitamin-mineral containing 0 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.

Outcome Measures

Primary Outcome Measures

Length of gestation [Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study]
the length of gestation will be measured in weeks at time of delivery

Secondary Outcome Measures

Birth weight [Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study]
Birth weight will be measured in grams and pounds
Birth length [Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study]
birth length will be measured in inches
Preterm birth [Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study]
Preterm birth will be measured in weeks at time of delivery
Preterm premature rupture of membranes (PPROM) [Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study]
PPROM will be measured in weeks at time of PPROM

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women who are between 10-20 weeks gestational age at the time of recruitment
Delivery at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center

Exclusion Criteria:

Use of prescription strength, high dose fluoride products (greater than 0.76% of fluoride), prescribed by a dental professional (toothpastes, mouthwashes, topical treatments). All over-the-counter toothpaste and mouthwash products are acceptable to use.
Occupational exposure to fluoride.
The daily amount of fluoride ingested should not exceed 10 mg/day, according to the Institute of Medicine and the FDA. Any participants consuming amounts of fluoride close to 10 mg/day will be excluded.