Water From Bottles to Establish Strong Teeth

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Proof-of-concept Randomized Controlled Trial to Evaluate Dental Caries Preventive Effects of Fluoridated Bottled Water

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Other: Fluoridated bottled drinking water
* Other: Non-fluoridated drinking water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The parent/guardian/caregiver understands and consents to procedures described in parental permission and consent form. Child is aged 2 months to 6 months at the screening visit. 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: The child's primary dwelling at the screening visit has tap water that contains >0.60 mg/L F and the parent/guardian/caregiver expresses a preference that the child drink tap water, not bottled water, for the child's first four years of life. For children who live at more than one dwelling, the primary dwelling is defined as the one at which they usually sleep at least four nights per week. Child has serious illness/es requiring frequent inpatient hospitalization, as reported by the parent/ guardian/caregiver at the screening visit. Child's birth weight was less than 1,500 g (3 pounds 5 ounces). Child's gestational age was less than 34 weeks. Child uses fluoride supplements, as reported by the parent/ guardian/caregiver at the screening visit. Parent/guardian/caregiver states at the screening visit the child will initiate fluoride supplementation before the child's 4th birthday 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. The investigators determine that a child living at the same primary dwelling has already been enrolled in the study. (This means that if two or more children fulfilling the inclusion criteria live at the primary dwelling, the parent will be asked to select one such child to be the study participant.) Anything that, in the opinion of the principal investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomized, double-masked, placebo controlled, parallel group study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoridated bottle water<br>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 | Other: Fluoridated bottled drinking water<br>* 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.<br>|
| Placebo Comparator: Non-fluoridated bottled water<br>5-gallon bottles containing water from the North Lenoir Water Corporation's Black Creek aquifer which contains a negligible concentration of fluoride. | Other: Non-fluoridated drinking water<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Dental examination in year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Through study completion, an average of 42 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorides