Clinical trial NCT04893681: Water From Bottles to Establish Strong Teeth
Official title: Proof-of-concept Randomized Controlled Trial to Evaluate Dental Caries Preventive Effects of Fluoridated Bottled Water
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Keywords: Fluorides
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Tulane University
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2021-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomized, double-masked, placebo controlled, parallel group study.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: dmfs index
timeFrame: Dental examination in year 4
Secondary outcomes:
measure: Fluoride content of fingernail and toenail biospecimens
timeFrame: Up to three years after randomization.
measure: Adverse events
timeFrame: Through study completion, an average of 42 months.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Division of Pediatric and Public Health, UNC Adams School of Dentistry
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gary Slade, BDSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.