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

Must not have

Child's birth weight was less than 1,500 g (3 pounds 5 ounces)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to three years after randomization.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child was born weighing less than 3 pounds 5 ounces.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dental examination in year 4

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

dmfs index

Secondary study objectives

Adverse events

Fluoride content of fingernail and toenail biospecimens

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.

0 / 2Eligibility criteria met