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Fluoride
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to three years after randomization.
Awards & highlights
waterBEST Trial 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.Check my eligibility
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.See study design
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.
waterBEST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2 to 6 months old.
waterBEST Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
dmfs index
Secondary outcome measures
Adverse events
Fluoride content of fingernail and toenail biospecimens
waterBEST 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.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,842 Total Patients Enrolled
Tulane UniversityOTHER
115 Previous Clinical Trials
226,302 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,144 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 2 to 6 months old.My child often needs to be hospitalized for serious illnesses.My child takes fluoride supplements.My child was born weighing less than 3 pounds 5 ounces.My child's main home has tap water with fluoride above 0.60 mg/L, and I prefer they drink tap water.
Research Study Groups:
This trial has the following groups:- Group 1: Fluoridated bottle water
- Group 2: Non-fluoridated bottled water
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are presently taking part in this research project?
"Affirmative. The records hosted on clinicaltrials.gov signify that this medical experiment, which was initially posted online April 4th 2022, is currently in need of participants. Approximately 200 subjects must be accessed from a single healthcare location."
Answered by AI
Who is allowed to partake in this exploratory investigation?
"This research study calls for 200 participants aged 2 to 6 months old with dental caries."
Answered by AI
Are there any vacancies available for potential participants of this clinical trial?
"The information on clinicaltrials.gov affirms that this trial is actively searching for participants and has been since its initial post date of April 4th 2022. It was most recently edited July 14th 2022."
Answered by AI
Are participants under the age of sixty being accepted for enrollment in this research?
"The requirements for this trial specify that eligible people must be between 2 months and 6 months of age. Furthermore, there are 56 trials available to infants while 31 are accessible to seniors over the age of 65."
Answered by AI
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