200 Participants Needed

Fluoridated Water for Tooth Decay

(waterBEST Trial)

SC
Overseen BySonya Capps
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications. However, children using fluoride supplements are excluded from the study.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Fluoridated bottled drinking water for reducing tooth decay?

Research shows that fluoridated water is effective in reducing tooth decay, as seen in a study where a community water supply with fluoride significantly decreased cavities in children. This suggests that fluoridated bottled water could similarly help in preventing tooth decay.12345

What data supports the effectiveness of the treatment Fluoridated bottled drinking water for reducing tooth decay?

Research shows that fluoridated water is effective in reducing dental caries (tooth decay) in communities, as it provides a cost-effective way to administer fluoride, which helps prevent cavities.12345

Is fluoridated water safe for humans?

Fluoridated water can help prevent tooth decay, but too much fluoride can lead to dental or skeletal fluorosis, which are conditions that affect teeth and bones. It's important to monitor fluoride levels in drinking water to avoid these risks.34678

Is fluoridated water safe for humans?

Fluoridated water can help prevent tooth decay, but too much fluoride can lead to dental or skeletal fluorosis, which are conditions that affect teeth and bones. It's important to monitor fluoride levels in drinking water to avoid these risks.34678

How does fluoridated bottled drinking water differ from other treatments for tooth decay?

Fluoridated bottled drinking water is unique because it provides a consistent and controlled level of fluoride directly through daily water consumption, unlike other treatments that may require additional supplements or dental applications. This method helps prevent tooth decay by strengthening tooth enamel, while also reducing the risk of dental fluorosis compared to inconsistent fluoride levels in other bottled waters.12349

How does fluoridated bottled drinking water differ from other treatments for tooth decay?

Fluoridated bottled drinking water is unique because it provides a consistent and controlled level of fluoride directly through daily water consumption, unlike other treatments that may require additional supplements or dental applications. This method helps prevent tooth decay by strengthening tooth enamel, while also reducing the risk of dental fluorosis compared to inconsistent fluoride levels in other bottled waters.12349

What is the purpose of this trial?

The waterBEST study is a proof-of-concept, randomized, double-masked, placebo controlled, parallel group study evaluating dental caries-preventive effects of fluoridated bottled water compared to non-fluoridated bottled water in 4-year-old children.

Research Team

GS

Gary Slade, BDSc, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Inclusion Criteria

My child is between 2 to 6 months old.
The parent/guardian/caregiver understands and consents to procedures described in parental permission and consent form
Child either drinks water (either plain water, or water mixed with something) or is expected to drink water by their first birthday, as reported by the parent/guardian/caregiver at the screening visit

Exclusion Criteria

My child often needs to be hospitalized for serious illnesses.
Child's gestational age was less than 34 weeks
The parent/guardian/caregiver anticipates that the child will move to an address more than 30 miles from Kinston, NC before the child's 4th birthday
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Children receive either fluoridated or non-fluoridated bottled water delivered to households

3.5 years
Quarterly interviews, annual dental screenings

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Fluoridated bottled drinking water
  • Non-fluoridated drinking water
Trial Overview 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.
Participant Groups
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.

Fluoridated bottled drinking water is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Fluoridated water for:
  • Prevention of dental caries
  • Prevention of tooth decay
🇨🇦
Approved in Canada as Fluoridated water for:
  • Prevention of dental caries
  • Prevention of tooth decay
🇪🇺
Approved in European Union as Fluoridated water for:
  • Prevention of dental caries
  • Prevention of tooth decay

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

Tulane University

Collaborator

Trials
129
Recruited
259,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials
312
Recruited
853,000+

Findings from Research

A study of 30 brands of bottled water revealed that only 56.7% of them provided accurate labeling of fluoride concentrations, which is important for preventing dental fluorosis in young children.
Among the tested brands, 73.3% had fluoride levels below 0.3 ppm, but some brands exceeded this level without proper labeling, highlighting the need for dentists to consider bottled water fluoride content when prescribing supplements.
Fluoride concentration of bottled drinking waters.Ayo-Yusuf, OA., Kroon, J., Ayo-Yusuf, IJ.[2013]
The study analyzed 105 samples of bottled water over 30 days and found that distilled and purified bottled waters generally contain very low fluoride levels, averaging less than 0.03 ppm, which is important for dental health considerations.
In contrast, mineral and flavor-added bottled waters had higher fluoride concentrations, with mineral water averaging 0.32 ppm and fluoride-added water reaching 0.63 ppm, indicating that consumers should be aware of fluoride content when choosing bottled water for dental health.
Fluoride content of bottled water and its implications for the general dentist.Quock, RL., Chan, JT.[2013]
A study of 12 bottled waters in the UK revealed fluoride concentrations ranging from 0.10 to 0.80 mg/l, indicating significant variability among different brands.
Manufacturers often inaccurately label fluoride levels, which is important for dentists to consider when prescribing fluoride supplements, especially since some parents use these waters for baby formula, potentially increasing the risk of dental fluorosis.
The fluoride content of bottled drinking waters.Toumba, KJ., Levy, S., Curzon, ME.[2019]

References

Fluoride concentration of bottled drinking waters. [2013]
Fluoride content of bottled water and its implications for the general dentist. [2013]
The fluoride content of bottled drinking waters. [2019]
[Fluoride concentration in bottled waters sold in Chile]. [2014]
Efficacy of fluoride on dental caries reduction by means of a community water supply. [2013]
Risk assessment of fluoride exposure in drinking water of Tunisia. [2018]
Role of renal function in the association of drinking water fluoride and plasma fluoride among adolescents in the United States: NHANES, 2013-2016. [2022]
[Evaluation of fluoride content of bottled drinking waters in Brazil]. [2019]
Determination of fluoride in the bottled drinking waters in iran. [2021]
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