Water From Bottles to Establish Strong Teeth

NCT04893681 | Active Not Recruiting

• 3 other identifiers: 20-3273UG3DE02916921-017-E
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children

Keywords

Fluorides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fluoride content of fingernail and toenail biospecimens

  Up to three years after randomization.

• Adverse events

  Through study completion, an average of 42 months.

Study Arms (2)

Fluoridated bottle water

EXPERIMENTAL

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

Non-fluoridated bottled water

PLACEBO COMPARATOR

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

Interventions

Fluoridated bottled drinking water OTHER

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.

Fluoridated bottle water

Non-fluoridated drinking water OTHER

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.

Non-fluoridated bottled water

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Tulane University: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Division of Pediatric and Public Health, UNC Adams School of Dentistry

Chapel Hill, North Carolina, 27599-7455, United States

Location

Related Publications (2)

• 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.

  PMID: 17518963 BACKGROUND

• Sanders AE, Divaris K, Godebo TR, Slade GD. Effect of bottled fluoridated water to prevent dental caries in primary teeth: study protocol for a phase 2 parallel-group 3.5-year randomized controlled clinical trial (waterBEST). Trials. 2024 Mar 5;25(1):167. doi: 10.1186/s13063-024-08000-4.

  PMID: 38443989 DERIVED

Study Officials

• Gary Slade, BDSc, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be managed by the a Data Management System which will execute three tasks: 1. Study participants' treatment group allocation will be stored in a dataset accessible only to the masked data manager 2. A separate dataset will record unique identification codes that will be affixed as labels to 5-gallon bottles of water; the same dataset will also record the public water supply used to fill the bottle (New Bern or North Lenoir). After the barcode label is affixed, the processing slip indicating the bottle's source of water (New Bern or North Lenoir), will be removed, thereby masking the contents. 3. When new water bottles are to be delivered to a study participant's dwelling, the Data Management System will execute a bottle allocation routine that will retrieve the study participant's study group assignment and select from the supply of masked bottles the necessary number of masked bottles that conform with the study participant's treatment group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomized, double-masked, placebo controlled, parallel group study.

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 19, 2021
• Study Start: April 14, 2022
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)