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

Completed · Early Phase 1

Conditions studied: Preterm Birth, Preterm Labor, Bacteremia, Preterm Premature Rupture of Fetal Membranes

In brief

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.

Key facts

Study ID

NCT02536352

Run by

Johns Hopkins University

People needed

43

Starts

2015-10-01

Expected to finish

2019-10-01

Last updated by the study team

2019-11-05

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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