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.
This 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. Children will be allocated at random to receive either fluoridated or non-fluoridated sourced from two local public water systems. The water will be packaged into 5-gallon bottles and delivered to households during a 3½ year intervention period. During the intervention period, parents/guardians/caregivers will be interviewed quarterly to monitor children's general health and a dental screening will be conducted annually. Children's fingernail and toenail clippings will be collected annually and analyzed to determine the fluoride content as a biomarker of total fluoride intake. Dental caries experience, the primary endpoint, will be determined once in a dental examination conducted by a study dentist close to the time of the child's 4th birthday. For the primary aim, a least-squares, generalized linear model will estimate efficacy and its one-tailed, upper 80% confidence limit using the number of decayed, missing and filled primary tooth surfaces as the dependent variable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.
Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.
Division of Pediatric and Public Health, UNC Adams School of Dentistry
Chapel Hill, North Carolina, United States
dmfs index
The number of primary tooth surfaces that are decayed, missing or filled will be enumerated during dental examinations of children near the time of their 4th birthday. Decay will be assessed clinically at the threshold of macroscopic enamel loss, as per criteria defined by the International Caries Detection and Assessment System. Five surfaces per tooth will be enumerated in all primary teeth (maximum = 20 teeth per child), yielding a count of affected surfaces that can range from 0 (no dental caries experience) to 100 (worst possible extent of dental caries experience). The lower-case abbreviation "dmfs" signifies disease in the primary dentition, a convention used to distinguish it from equivalent measures for the permanent dentition, where an uppercase abbreviation is used, as defined for the National Library of Medicine's Medical Subject Heading heading "DMF Index".
Time frame: Dental examination in year 4
Fluoride content of fingernail and toenail biospecimens
Fluoride content of fingernail and toenail clippings will provide a biomarker of total fluoride intake at intervals of 1, 2 and 3 years after randomization. Fluoride content will be measured in mg/kg using a hexamethyldisiloxane-facilitated diffusion assay of nail clippings collected from study subjects.
Time frame: Up to three years after randomization.
Adverse events
Number of adverse events, sub-classified according to whether or not the event is serious, and whether or not the event is related (either possibly, probably or definitely) to the intervention.
Time frame: Through study completion, an average of 42 months.
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