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Fluoride

Fluoridated Water for Tooth Decay (waterBEST Trial)

N/A
Recruiting
Led By Gary Slade, BDSc, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child is aged 2 months to 6 months at the screening visit
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to three years after randomization.
Awards & highlights

waterBEST Trial Summary

This trial is testing whether fluoridated water can help prevent cavities in 4-year-olds, compared to non-fluoridated water.

Who is the study for?
This trial is for children aged 2 to 6 months who usually drink water or will by their first birthday. They must live in a primary residence with low fluoride tap water and not be on fluoride supplements. Children with very low birth weight, serious illnesses, or premature birth are excluded.Check my eligibility
What is being tested?
The study compares the effects of fluoridated bottled water versus non-fluoridated bottled water on preventing tooth decay in young children. It's a randomized, double-masked (neither researchers nor participants know which group they're in), placebo-controlled trial.See study design
What are the potential side effects?
Fluoridated water may cause mild dental fluorosis if consumed at high levels over long periods but is generally considered safe and effective at preventing tooth decay when used appropriately.

waterBEST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 2 to 6 months old.

waterBEST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dental examination in year 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and dental examination in year 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
dmfs index
Secondary outcome measures
Adverse events
Fluoride content of fingernail and toenail biospecimens

waterBEST Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fluoridated bottle waterExperimental Treatment1 Intervention
5-gallon bottles containing water from the New Bern Water Resources Division's Black Creek aquifer which contains naturally-occurring fluoride in a concentration of approximately 0.8 mg/L F
Group II: Non-fluoridated bottled waterPlacebo Group1 Intervention
5-gallon bottles containing water from the North Lenoir Water Corporation's Black Creek aquifer which contains a negligible concentration of fluoride.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,520 Previous Clinical Trials
4,196,380 Total Patients Enrolled
Tulane UniversityOTHER
117 Previous Clinical Trials
237,425 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,144 Total Patients Enrolled

Media Library

Fluoridated bottled drinking water (Fluoride) Clinical Trial Eligibility Overview. Trial Name: NCT04893681 — N/A
Tooth Decay Research Study Groups: Fluoridated bottle water, Non-fluoridated bottled water
Tooth Decay Clinical Trial 2023: Fluoridated bottled drinking water Highlights & Side Effects. Trial Name: NCT04893681 — N/A
Fluoridated bottled drinking water (Fluoride) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893681 — N/A
~98 spots leftby Jun 2026
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