Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being
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| ClinicalTrials.gov Identifier: NCT02536352 |
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Recruitment Status :
Completed
First Posted : August 31, 2015
Last Update Posted : November 5, 2019
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| 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 |
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 Type : | Interventional (Clinical Trial) |
| 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 : | October 2015 |
| Actual Primary Completion Date : | October 1, 2019 |
| Actual Study Completion Date : | October 1, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fluoride prenatal vitamin
Prenatal vitamin-mineral containing 3 mg fluoride
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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. |
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Active Comparator: Standard prenatal vitamin
Prenatal vitamin-mineral containing 0 mg fluoride
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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. |
- 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
- 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
- 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
- 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
- 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 |
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.
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
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| Principal Investigator: | Irina Burd, M.D., Ph.D. | Johns Hopkins University |
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT02536352 |
| Other Study ID Numbers: |
IRB00038838 |
| First Posted: | August 31, 2015 Key Record Dates |
| Last Update Posted: | November 5, 2019 |
| Last Verified: | November 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Fluoride Supplementation Prenatal Vitamin Pregnancy Nutrition Prenatal Nutrition |
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Bacteremia Premature Birth Obstetric Labor, Premature Fetal Membranes, Premature Rupture Rupture Obstetric Labor Complications Pregnancy Complications Wounds and Injuries Bacterial Infections Bacterial Infections and Mycoses Infections |
Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Vitamins Fluorides Micronutrients Physiological Effects of Drugs Cariostatic Agents Protective Agents |