Fluoridated Water for Tooth Decay

(waterBEST Trial)

Overseen By Sonya Capps

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Fluoride supplements

Disqualifiers: Serious illness, Low birth weight, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether fluoridated bottled water can prevent tooth decay in young children. Children in the study will drink either fluoridated water or non-fluoridated water to determine which is more effective at maintaining dental health. The trial targets children aged 2 to 6 months who are expected to drink water by their first birthday. As an unphased trial, it provides a unique opportunity for parents to contribute to important research that could enhance dental health guidelines for young children.

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 prior data suggests that fluoridated bottled drinking water is safe for children?

Research has shown that fluoridated water is safe and effective in reducing tooth decay. Studies have found that adding fluoride to drinking water significantly reduces cavities in children. This practice has been common in many communities for decades. Public health experts state that fluoridated water not only helps prevent cavities but is also safe to drink.

In this study, the fluoridated bottled water comes from a natural source with fluoride. It contains about 0.8 mg/L of fluoride, similar to levels used in many public water systems to support dental health.

Although some concerns about fluoride have been raised in the past, extensive research supports its safety. For example, the American Dental Association and the Centers for Disease Control and Prevention recognize water fluoridation as a safe and effective way to prevent tooth decay. Therefore, participants in this study can feel confident about the safety of fluoridated bottled water based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using fluoridated bottled water to combat tooth decay because it leverages naturally-occurring fluoride from a specific aquifer, offering a potentially more accessible alternative to traditional methods like fluoride varnishes or toothpaste. Unlike standard treatments that require direct application on teeth, this method integrates fluoride into daily drinking habits, making it easier for people to maintain. By providing a consistent fluoride intake through bottled water, it could enhance dental health in communities where traditional fluoride treatments are less accessible or practiced.

What evidence suggests that fluoridated bottled drinking water is effective for preventing tooth decay in children?

Research has shown that fluoridated water can greatly reduce tooth decay. One study found it reduced cavities by 35% in baby teeth and 26% in adult teeth. Another study demonstrated a reduction in tooth decay by up to 27% in adults of all ages. Fluoridated water has also played a crucial role in helping both children and adults maintain healthier teeth over time. In this trial, participants will receive either fluoridated bottled water or non-fluoridated bottled water to evaluate its effectiveness in preventing tooth decay in young children. ^{1 2 6 7 8}

Who Is on the Research Team?

Gary Slade, BDSc, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Fluoridated bottle water Experimental Treatment 1 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 water Placebo Group 1 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

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+

Published Research Related to This Trial

A survey of fluoridated tap water in Tunisia revealed fluoride concentrations ranging from 0 to 2.4 mg L-1, indicating a significant variation in fluoride levels across different consumption points.

The study found that about 25% of the population is at risk for dental fluorosis and 20% for skeletal fluorosis, highlighting the need for further investigation into fluoride exposure from all drinking water sources, including bottled water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk assessment of fluoride exposure in drinking water of Tunisia. Guissouma, W., Hakami, O., Al-Rajab, AJ., et al.[2018]

In a study of 1841 healthy adolescents, it was found that lower renal function (measured by eGFR) is associated with higher plasma fluoride levels, particularly in those consuming fluoridated drinking water.

For adolescents with the lowest eGFR, a higher concentration of fluoride in drinking water significantly increased plasma fluoride levels, suggesting that individuals with impaired kidney function may be at greater risk for fluoride accumulation, warranting further investigation into the effects of water fluoridation on those with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of renal function in the association of drinking water fluoride and plasma fluoride among adolescents in the United States: NHANES, 2013-2016. Danziger, J., Dodge, LE., Hu, H.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoride content of bottled water and its implications for the general dentist. Quock, RL., Chan, JT.[2013]

A study analyzing 104 brands of bottled mineral water in Brazil found varying fluoride concentrations, with some brands containing significant levels not disclosed by producers, raising safety concerns.

Certain bottled waters were marketed as fluoridated but had fluoride levels too low to prevent dental caries or high enough to risk dental fluorosis, highlighting the need for regulatory oversight on fluoride content in these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of fluoride content of bottled drinking waters in Brazil]. Villena, RS., Borges, DG., Cury, JA.[2019]

A study involving 200 children from the City of New Orleans demonstrated that a fluoridated water supply significantly reduces the number of dental caries (tooth decay) lesions and the need for extractions.

The research highlights that using fluoridated community water is a cost-effective method for administering fluoride, benefiting children's dental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fluoride on dental caries reduction by means of a community water supply. Fos, PJ., Pittman, JM.[2013]

The study analyzed fluoride content in 18 brands of bottled water, finding an average fluoride level of 0.202 mg/L, which is below the safe limit of 1 mg/L for drinking water.

While bottled water may reduce the risk of fluorosis in areas with high fluoride tap water, it could increase the risk of dental caries, suggesting that individuals should consider fluoride supplements if they primarily consume bottled water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of fluoride in the bottled drinking waters in iran. Amanlou, M., Hosseinpour, M., Azizian, H., et al.[2021]

In a study analyzing 30 bottled water samples in Chile, only 10% had fluoride concentrations within the optimal range (0.6 to 1.0 ppm) for preventing dental caries, indicating limited anticaries benefits from most bottled waters.

The fluoride levels in most bottled waters were low enough to not significantly increase the risk of dental fluorosis, suggesting that while they may not be effective for caries prevention, they are generally safe in terms of fluorosis risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fluoride concentration in bottled waters sold in Chile]. Fernández, CE., Giacaman, RA., Cury, JA.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fluoride content of bottled drinking waters. Toumba, KJ., Levy, S., Curzon, ME.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoride concentration of bottled drinking waters. Ayo-Yusuf, OA., Kroon, J., Ayo-Yusuf, IJ.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10913546/

Effect of bottled fluoridated water to prevent dental caries in ... It found a caries prevented fraction of 35% in the primary dentition (i.e., deciduous teeth) and of 26% in the permanent dentition. While ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8971694/

Maintaining Good Oral Health With Fluoridated Water - PMC Results demonstrate that fluoridated water may reduce the risk of dental caries by up to 27% in adults of all ages.

3. uchealth.org uchealth.org/today/the-truth-about-fluoride-in-water-a-public-health-story-with-colorado-roots/

The truth about fluoride in water: A public health success ... Fluoride in water has dramatically reduced cavities and tooth decay for children. It has also helped adults keep more of their teeth.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04893681

Water From Bottles to Establish Strong Teeth (waterBEST) This is a proof-of-concept, randomized, double-masked, placebo controlled, parallel group study evaluating dental caries-preventive effects of fluoridated ...

5. fda.gov fda.gov/media/157769/download

Fluoride Bottled Water - FRIA (2021-253) Clean 2-14-22.docx optimal level of fluoride in community water systems to prevent dental caries (tooth decay). The current allowable levels range 0.8–1.7 mg/L ...

6. ada.org ada.org/resources/community-initiatives/fluoride-in-water

Fluoridation in Water It prevents tooth decay. Fluoride in water is the most efficient way to prevent cavities, one of the most common childhood diseases. · It protects all ages ...

7. cancer.org cancer.org/cancer/risk-prevention/chemicals/water-fluoridation-and-cancer-risk.html

Water Fluoridation and Cancer Risk This is a review of the possible link between water fluoridation and cancer. Other possible health effects of fluoridation (positive or negative) are not ...

8. cdc.gov cdc.gov/fluoridation/faq/index.html

Community Water Fluoridation Frequently Asked Questions Fluoride combines with outer enamel tooth layers, preventing cavities by making teeth stronger and more resistant to decay. Almost all water ...