Information for Study Participants
Purpose of study
The purpose of the waterBEST research study is to learn if fluoride in bottled water helps to prevent tooth decay in young children.
How to enroll
Your child may be eligible to enroll if they are aged between 2 – 6 months and living in Lenoir or Wayne County, NC. If your child is eligible, someone from the waterBEST study team will give you more information about the study. If you’d like to enroll your child, we will obtain your informed consent. Click here to pre-enroll in the study.
Randomization
The study water will either be fluoridated or non-fluoridated and will be assigned by chance, like flipping a coin. This is called randomization. Your child will receive the same type of water throughout the study. The research team will not know whether the bottles of water given to your child contain fluoride.
Water delivery
We will deliver 5-gallon water bottles to your home at monthly intervals for about 3.5 years. We will also take away empty water bottles. For children fed powered infant formula, we additionally provide 3 gallon bottles of non-study unfluoridated water used exclusively for reconstituting infant formula.
Each month we will conduct a brief interview with you by phone. We will ask how much water has been used. We will also arrange delivery of new water bottles.
Activities every third month
Every third month for about 3.5 years, a study team member will interview you, either by phone, videoconference or in person at your home, to update your child’s health status and record any major illnesses. You will be told if your child is due to visit your primary healthcare provider.
Yearly activities
Once a year our dental hygienist will check your child’s teeth. This will be done at your home. The dental hygienist will also recommend if the child needs to be seen by a dentist.
Nail clippings
Fingernail and toenail clippings will be collected annually and sent to our laboratory to measure their fluoride content. Samples of tap water and study water from your home will be collected at the same time, also for fluoride content measurement.
Dental examination
Your child will receive a full dental examination about the time of their 4th birthday. This will be done by Dr. Ginnis, a licensed board-eligible pediatric dentist.
Sources of water
Water from the Black Creek Aquifer is treated by the City of New Bern and the North Lenoir Water Corporation to ensure its safety for drinking. We add the additional step of ozone disinfection to purify the water before bottling.
Our team
Carina, JC, Hannah, and Michele manage our study from the Kinston warehouse. As well as conducting phone calls and interviews, they are busy bottling, racking and delivering water.
Kinston warehouse
Our bottling facility is located at 2419 N Herritage St, Kinston, NC 28501