Every month the study team will call to see if you need a delivery of 5-gallon water bottles, and a study team member will make a delivery if needed. Families are asked to give their child the study water provided by the study team (not tap water). Children should continue their usual diet and health care.
Every 3 months, parents will be interviewed about their child’s health. Once a year, your child will have a dental check at home.
When your child turns 4-years old, they will have a dental exam at home.
Participants will be enrolled from April 2022 through December 2024. Study visits will occur through 2027.
Bottled water, water cooler, infant bottles and sippy cups will be provided to you at no cost throughout the study. Monetary compensation up to $480 will also be provided.
The study is funded by the National Institutes of Health and is being conducted by the UNC Adams School of Dentistry at Chapel Hill with a field research office located in Kinston NC.
Yes, the study water is safe to drink. It comes from two water systems that provide drinking water to people in eastern NC: the North Lenoir Water Corporation and the New Bern Water Resources division. Their water comes from the Black Creek aquifer and they purify it using treatment techniques required by the federal Safe Drinking Water Act. Their water meets the United States Environmental Protection Agency legally enforceable standards. When bottling their water, we add an additional step of ozone disinfection which is commonly used by bottled water suppliers to remove any bacteria from water supplies.
Fluoride is a mineral found naturally in varying amounts in water sources such as rivers and lakes. Fluoride also occurs naturally in certain foods and beverages. To help protect teeth from cavities, fluoride is also added to some dental products such as toothpaste.
Yes, this study is safe. As explained in the Consent Form, the only possible risk is that a child ingests too much fluoride. This could occur if a child takes a prescription fluoride supplement in addition to the study water, or if a child drinks infant formula powder or concentrate that is mixed with study water. To avoid these risks, parents are asked about fluoride supplements at three-monthly interviews. If you plan to use infant formula powder or concentrate, we provide you with unfluoridated bottled water solely for use in mixing with the infant formula powder.
If a child were to ingest too much fluoride, it would increase the risk of their permanent teeth developing faint white lines or streaks.
No, children enrolled in the study can drink other beverages. We only ask that when your child drinks water, that the study water is the only water that they drink. We also ask that when water is used in meal preparation, that study water is the sole source of water used.
No, you will not have to travel to participate in this study. In fact, activities such as interviews will occur by phone and other activities such as water deliveries and dental assessments will be conducted in the child’s home.
Many people have questions about dental fluorosis. Dental fluorosis is not being investigate in the waterBEST research study because the children are too young to show any signs of it. However, we would like to take a moment to cover what dental fluorosis is and what it looks like.
The pictures below show the different degrees of dental fluorosis that are seen in the world. Most dental fluorosis in the U.S. is very mild to mild, appearing as white spots on the tooth surface that may be barely noticeable and do not affect dental function. Severe dental fluorosis does not occur from fluoride in the water from New Bern which where the level of fluoride is equivalent fluoridated public water systems in the U.S. Recent research has shown that very mild and mild dental fluorosis fades during adolescence and young adulthood.
Photos courtesy of the CDC https://www.cdc.gov/fluoridation/faqs/dental_fluorosis/index.htm
Dr. McKay contacted his dental school instructors to ask about this as they’d never learned about it in dental school. They did not have any answers. The U.S. Public Health Service was called in to help with this discovery. Imagine not having almost any cavities in 1901! That was big news. The stain on the teeth was initially called Colorado brown stain. That name later became changed to mottled enamel and ultimately dental fluorosis.
Over a period of 30 years of study and careful research, the U.S. Public Health Service discovered that people in some other communities had this same stain and very few cavities, while in other communities’ people had very few cavities and nice looking teeth. The thing that these families did in common was to drink from the same water sources in these communities. In testing the water in Colorado Springs as well as these communities without brown stains on the teeth, it was found that fluoride in the water was high in Colorado Springs (2-12 milligrams of fluoride/liter of water) while in the other communities it was lower (1 milligram/liter). Mother Nature had shown how low levels of fluoride would make the teeth harder and much more resistant to cavities without any visible stains. The story about the timeline of this major discovery can be read here https://www.cdc.gov/fluoridation/basics/timeline.html
The type of research that was done by the U.S. Public Health Service is called an Observational Study. They were observing differences that occurred naturally, in the community – in this case, the underlying cause of the difference was the differing levels of fluoride created by Mother Nature. In later years, other observational studies discovered that lung cancer is caused by tobacco smoking, and that liver disease (cirrhosis) is caused by excessive alcohol consumption.
The waterBEST study design is using a different type of study called a Randomized Controlled Clinical Trial. This study differs from Observational Studies in that the study is determining who drinks fluoridated water and who does not, rather than relying on the level of fluoride that happens to be in the tap water that children drink. Using a process of random allocation (like tossing a coin), children in the study are given either water from New Bern that naturally contains fluoride at the levels that prevents decay without causing dental fluorosis, versus water from North Lenoir County, that has a much lower level of fluoride. As an extra step of scientific rigor, nobody in the study team at Kinston knows what type of water is given to any particular house, and nor does Dr. Slade, the study’s lead investigator. Instead, a computer keeps record of the type of water to be delivered to each household. This is called “blinding” or “masking” of the study team and study participants. This kind of blinded, randomized controlled clinical trial provides the strongest evidence about the effects of fluoride on health, just as randomized controlled clinical trials provide the necessary proof that vaccines and medicines are safe and beneficial.
Because a randomized controlled clinical trial of fluoride in drinking water has never been done, results of the waterBEST study are being watched closely by people around the world. If this study proves that cavities can be reduced by providing fluoridated water to communities without is by providing 5 gallon bottles of water, think of the remote areas of the world where this could be applied to reduce this most common long-term disease of children and adults around the world. For instance, in remote areas of Alaska where Native Americans and Alaska Natives do not have access to running water and many have to melt ice for drinking water, they are not able to have access to fluoridated water. Eastern NC counties are on the cutting edge of revealing a very likely answer to what researchers said could never be done. And this research will potentially become a major scientific breakthrough on how to benefit adults and children who aren’t getting enough fluoride in their drinking water to receive the benefits of this naturally occurring mineral, fluoride.
Our study design requires that we enroll boys and girls of all racial groups and cultural backgrounds. We are approaching all households in Lenoir County with newborn children. Everything done in the waterBEST study must adhere to the study protocol which states “This study has no exclusions based on sex/gender, race, or ethnicity” Independent authorities oversee and monitor the study to assure that the protocol is followed. Those authorities include UNC’s Institutional Review Board and a Data and Safety Monitoring Board established by National Institutes of Health.
Initial reports from the National Toxicology Program looked at studies with much higher levels of fluoride than our study. They have not released a final report. In 2019 and 2020, the National Toxicology Program (NTP) produced draft reports on this topic. NTP asked the National Academies of Sciences, Engineering and Medicine to act as a peer reviewer for its report. Peer review is a very important process because it provides an independent evaluation to ensure that the quality of a report is sound and that the writers of the report used consistent standards and did not overlook important details of the research. Typically, a report or study that fails to complete the peer review process is not published.
Both drafts of the NTP report were found to be deficient when assessed by an independent panel of the National Academies. The panel was critical of the fact that most of the studies reviewed by NTP involve relatively high fluoride concentrations, far exceeding levels used in public water systems in the United States. In particular, the panel concluded that the NTP’s second draft report “cannot be used to draw conclusions regarding low fluoride exposure concentrations (less than 1.5 mg/L), including those typically associated with drinking water fluoridation.” (https://doi.org/10.17226/26030) The NTP was due to produce a final report in May, 2022, but as of September, 2022 it has yet to be released.
In the waterBEST study, the fluoridated water is from a well of the Black Creek aquifer that naturally contains fluoride at the level recommended by the Centers for Disease Control and Prevention for prevention of tooth decay. That level is far below most of the studies reviewed by the NTP. People in New Bern have been drinking water from the well for decades. Across the state, approximately 80% of North Carolinians safely drink water that has a similar level of fluoride.
Yes, we read expert recommendations and consulted a physician whose job is to make sure the study is safe for children.
The safety of participants in the waterBEST study has been reviewed and approved by experts with a range of relevant medical and scientific qualifications who serve on oversight panels. This includes UNC’s Institutional Review Board, a Data and Safety Monitoring Board, and the study’s medical monitor appointed by the National Institutes of Health.
We also considered evidence published by a team of 31 toxicologists and food safety experts who reviewed the evidence related to fluoride’s effect on cognitive development (IQ; neurodevelopment). Those experts concluded in 2020 that the evidence “does not provide sufficient arguments to raise concerns with regard to [water fluoridation] in the range of 0.7–1.0 mg/L.” (https://doi.org/10.1007/s00204-020-02725-2)
This was not the purpose of this study. If the waterBEST study was to study IQ or dental fluorosis it would have to be approved through NIH’s peer review process.
The waterBEST study is funded by the National Institutes of Health (NIH) to address specific research questions regarding the safety and efficacy of fluoride in bottled water for prevention of tooth decay. Those study aims and the scientific approach to be used in the study were reviewed by an independent scientific review panel that evaluates research grant applications submitted to NIH. Independent scientific review is an essential requirement for NIH funding because it assures that study protocol is rigorous, and the researchers are trustworthy and properly qualified.
If additional topics are to be studied, such as IQ or dental fluorosis, new specific aims would have to be scientifically reviewed, approved, and funded by NIH. As of September 2022, the waterBEST investigators have not proposed new specific aims for the study.
Would you like to learn more about dental fluorosis? Please read it here: Dental Fluorosis
We are not studying ADHD. If a child is diagnosed with it, parents should speak to a doctor.
The waterBEST study’s specific aims do not address research questions about attention deficit hyperactivity disorder (ADHD). Therefore, if a child were to develop ADHD, the waterBEST investigators would be unable to comment on possible causes. Instead, medical advice should be obtained. Please also note that the study does not provide health care to children in the study. If a child developed ADHD, the investigators would, if requested by the family, help them get health care.
No adverse health effects of any sort have been determined to be related to the low fluoride levels in this study, including ADHD or IQ/neurological deficits, except mild dental fluorosis. Dental fluorosis is a cosmetic change in the enamel of the teeth which is typically only visible to dental professionals under a bright light when the teeth are dried off.
The U.S. Justice Department paid Dr. Slade a usual rate as an expert witness for the work he did over two years.
Dr. Slade served as an expert witness in a lawsuit filed against the United States Environmental Protection Agency. Specifically, he was asked to report on the three decades of research studies about water fluoridation and dental decay that he has done. He worked on the case from 2018 to 2020 and was reimbursed by the Department of Justice using a rate that is paid commonly to expert witnesses.
Families are paid because taking part in research places impositions on them. The amount is based on guidelines of the U.S. Department of Health and Human Services for research studies.
To help compensate for their time and effort, families will receive up to $480 if they complete all aspects of the study over the four-year follow-up period. The amount is approved by UNC’s Institutional Review Board which weighs up the impositions required to participate in research with the potential for coercion if payment is excessive. This is consistent with guidance from the Office of Human Research Protections at the U.S. Department of Health and Human Services (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html )
UNC’s Institutional Review Board requires that all clinical trials use that wording.
The section of the consent form concerning health care for study participants contains standard text that is required by UNC’s Institutional Review Board for nearly all clinical studies. Regarding a possible lawsuit, the consent form states: “By signing this form, you/your child do not give up your right to seek payment or other rights if your child is harmed as a result of being in this study.” (https://waterbeststudy.com/wp-content/uploads/2022/09/waterBEST_Parental_Permission_Adult_Consent_Form_2021-12-17.pdf )
The results of the study are reported to the National Institutes of Health and to UNC’s Institutional Review Board.
The goal is to enroll and randomize 200 children by the end of 2023. Study results, including enrollment rates, are reported to the National Institutes of Health and to UNC’s IRB. The study protocol does not provide for interim reports of study results prior to completion of the study.
The waterBEST study team members are paid by UNC.
The University of North Carolina at Chapel Hill has been funded by the National Institutes of Health (NIH) to conduct the waterBEST research study. NIH funding is pursuant to federal regulations 42 USC 241 31 USC 6305 42 CFR 52. UNC manages the funds consistent with federal and state policies (https://research.unc.edu/sponsored-programs/resources/information-sheet/) UNC uses the funds to pay for direct research costs and to support salaries of faculty and staff on the study team. Salaries are consistent with compensation policies of UNC and the state of North Carolina (https://hr.unc.edu/employees/class-comp/policies/ ) Study team members do not get a salary bonus for their work on the study. There is no money left over when a study is completed.
We encourage people to visit our warehouse in the Kinston Plaza and to read about the study at our website https://waterbeststudy.com/. To add anything besides disinfectant to the water would be against the study design and would be grounds for immediate stoppage of this study.
Please visit our study warehouse in the Kinston Plaza to learn all about the study from the waterBEST team and to tour the facility. It is best to phone ahead to plan your visit: 919-445-5140.
At the warehouse, you can see where we bottle the water which we obtain locally, from two wells of the Black Creek aquifer. At our warehouse, we do a final ozone disinfection of the water prior to bottling, but we do not add anything to the water. You can see the bottling system in operation in this video: https://videos.files.wordpress.com/3l0taJzX/waterbest-cut-one-v1-5-22.mp4
You can read the study protocol and learn about all other aspects of the study at our website: https://waterbeststudy.com/
Please also speak with trusted community leaders in Kinston and Lenoir County including the Lenoir County Health Department and the Kinston Community Health Center. Your dentist and pediatrician can also be helpful resources to learn more about fluoride.
The safety and wellbeing of children and families in waterBEST is assured by many independent groups that supervise all aspects of the study, including the study investigators. Those groups are accountable to state or federal government agencies and, in turn, to our elected officials. The oversight groups include:
· UNC’s Institutional Review Board: phone 919-966-3113, email IRB_subjects@unc.edu.
· UNC’s Office of Research: https://research.unc.edu/about/
· National Institutes of Health/National Institute of Dental and Craniofacial Research: https://www.nidcr.nih.gov/
We are leaving pamphlets all over Kinston and Lenoir County so that all families learn about the study.
waterBEST pamphlets and other publicity are available at locations throughout Kinston and Lenoir County. This map shows locations in Kinston.
Kinston-based artist, Seraphim Smith, who is also an active culinary teacher and documentary filmmaker said, “I designed the waterBEST mural to include a local representation of our population based upon true percentages. I was tasked to include children who were between one and four years old, a representation of the City of Kinston buildings, and the tooth logo with the words waterBEST.” In the 2020 census, the City of Kinston was comprised of 68% Black, 25% White and 7% other races or ethnicities.
We wouldn’t know the impact until after the study has been completed.
When studies enroll fewer participants than planned, it sometimes restricts the conclusions that can be drawn from the results. The actual impact cannot be known until the study has been completed.
We record how much water and fluoride children consume so that we can answer those questions.
We are carefully monitoring water consumption by all participants in the study. We are also assessing children’s total fluoride intake which we measure using fingernail and toenail clippings. We will use the information to compare the two study groups at the end of the study to see if average water consumption differs between the two study groups.