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

Primary Purpose

Preterm Birth, Preterm Labor, Bacteremia

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prenatal vitamin-mineral containing 3 mg fluoride
Prenatal vitamin-mineral containing 0 mg fluoride
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Birth focused on measuring Fluoride Supplementation, Prenatal Vitamin, Pregnancy Nutrition, Prenatal Nutrition

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluoride prenatal vitamin

Standard prenatal vitamin

Arm Description

Prenatal vitamin-mineral containing 3 mg fluoride

Prenatal vitamin-mineral containing 0 mg fluoride

Outcomes

Primary Outcome Measures

Length of gestation
the length of gestation will be measured in weeks at time of delivery

Secondary Outcome Measures

Birth weight
Birth weight will be measured in grams and pounds
Birth length
birth length will be measured in inches
Preterm birth
Preterm birth will be measured in weeks at time of delivery
Preterm premature rupture of membranes (PPROM)
PPROM will be measured in weeks at time of PPROM

Full Information

First Posted
August 27, 2015
Last Updated
November 4, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02536352
Brief Title
Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being
Official Title
Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Preterm Labor, Bacteremia, Preterm Premature Rupture of Fetal Membranes
Keywords
Fluoride Supplementation, Prenatal Vitamin, Pregnancy Nutrition, Prenatal Nutrition

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoride prenatal vitamin
Arm Type
Experimental
Arm Description
Prenatal vitamin-mineral containing 3 mg fluoride
Arm Title
Standard prenatal vitamin
Arm Type
Active Comparator
Arm Description
Prenatal vitamin-mineral containing 0 mg fluoride
Intervention Type
Drug
Intervention Name(s)
Prenatal vitamin-mineral containing 3 mg fluoride
Intervention Description
Prenatal vitamin-mineral containing 3 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Prenatal vitamin-mineral containing 0 mg fluoride
Intervention Description
Prenatal vitamin-mineral containing 0 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.
Primary Outcome Measure Information:
Title
Length of gestation
Description
the length of gestation will be measured in weeks at time of delivery
Time Frame
Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study
Secondary Outcome Measure Information:
Title
Birth weight
Description
Birth weight will be measured in grams and pounds
Time Frame
Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study
Title
Birth length
Description
birth length will be measured in inches
Time Frame
Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study
Title
Preterm birth
Description
Preterm birth will be measured in weeks at time of delivery
Time Frame
Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study
Title
Preterm premature rupture of membranes (PPROM)
Description
PPROM will be measured in weeks at time of PPROM
Time Frame
Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irina Burd, M.D., Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9165186
Citation
Leverett DH, Adair SM, Vaughan BW, Proskin HM, Moss ME. Randomized clinical trial of the effect of prenatal fluoride supplements in preventing dental caries. Caries Res. 1997;31(3):174-9. doi: 10.1159/000262394.
Results Reference
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PubMed Identifier
19375568
Citation
Srinivas SK, Sammel MD, Stamilio DM, Clothier B, Jeffcoat MK, Parry S, Macones GA, Elovitz MA, Metlay J. Periodontal disease and adverse pregnancy outcomes: is there an association? Am J Obstet Gynecol. 2009 May;200(5):497.e1-8. doi: 10.1016/j.ajog.2009.03.003.
Results Reference
background
PubMed Identifier
23115811
Citation
Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academies Press (US); 1997. Available from http://www.ncbi.nlm.nih.gov/books/NBK109825/
Results Reference
background
PubMed Identifier
28605006
Citation
Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. Treating periodontal disease for preventing adverse birth outcomes in pregnant women. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD005297. doi: 10.1002/14651858.CD005297.pub3.
Results Reference
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Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being

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