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

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ClinicalTrials.gov Identifier: NCT02536352
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 investigaors 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 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 : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

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.




Primary Outcome Measures :
  1. Length of gestation [ Time Frame: 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 :
  1. Birth weight [ Time Frame: 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

  2. Birth length [ Time Frame: 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

  3. Preterm birth [ Time Frame: 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

  4. Preterm premature rupture of membranes (PPROM) [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536352


Contacts
Contact: Irina Burd, M.D., Ph.D. 410-955-8496 iburd@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Irina Burd, M.D., Ph.D.    410-955-8496    ircfm@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Irina Burd, M.D., Ph.D. Johns Hopkins University

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02536352     History of Changes
Other Study ID Numbers: IRB00038838
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Fluoride Supplementation
Prenatal Vitamin
Pregnancy Nutrition
Prenatal Nutrition

Additional relevant MeSH terms:
Premature Birth
Rupture
Bacteremia
Obstetric Labor, Premature
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vitamins
Fluorides
Micronutrients
Growth Substances
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents