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Water From Bottles to Establish Strong Teeth (waterBEST)

Primary Purpose

Dental Caries in Children

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fluoridated bottled drinking water

Non-fluoridated drinking water

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring Fluorides

Eligibility Criteria

2 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

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.
The child's primary dwelling at the screening visit has tap water that contains ≤0.60 mg/L F, based on measurement of a tap water sample made at Dr. Godebo's laboratory. 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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluoridated bottle water

Non-fluoridated bottled water

Arm Description

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

5-gallon bottles containing water from the North Lenoir Water Corporation's Black Creek aquifer which contains a negligible concentration of fluoride.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04893681

First Posted

May 7, 2021

Last Updated

October 6, 2023

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Tulane University, National Institute of Dental and Craniofacial Research (NIDCR)

1. Study Identification

Unique Protocol Identification Number

NCT04893681

Brief Title

Water From Bottles to Establish Strong Teeth

Acronym

waterBEST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 4, 2022 (Actual)

Primary Completion Date

June 2026 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Tulane University, National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries in Children

Keywords

Fluorides

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Masking will be managed by the a Data Management System which will execute three tasks: Study participants' treatment group allocation will be stored in a dataset accessible only to the masked data manager 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. 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.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fluoridated bottle water

Arm Type

Experimental

Arm Description

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

Arm Title

Non-fluoridated bottled water

Arm Type

Placebo Comparator

Arm Description

5-gallon bottles containing water from the North Lenoir Water Corporation's Black Creek aquifer which contains a negligible concentration of fluoride.

Intervention Type

Other

Intervention Name(s)

Fluoridated bottled drinking water

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Non-fluoridated drinking water

Intervention Description

Primary Outcome Measure Information:

Title

dmfs index

Description

Time Frame

Dental examination in year 4

Secondary Outcome Measure Information:

Title

Fluoride content of fingernail and toenail biospecimens

Description

Time Frame

Up to three years after randomization.

Title

Adverse events

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sonya Capps

Phone

919-537-3269

sonya_capps@unc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Slade, BDSc, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7455

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gary D Slade, BDSc, PhD

Phone

919-537-3273

gary_slade@unc.edu

First Name & Middle Initial & Last Name & Degree

Anne E Sanders, PhD

Phone

919-537-3275

anne_sanders@unc.edu

First Name & Middle Initial & Last Name & Degree

Gary D Slade, BDSc, PhD

First Name & Middle Initial & Last Name & Degree

Anne E Sanders, PhD

First Name & Middle Initial & Last Name & Degree

Kimon Divaris, DDS, PhD

First Name & Middle Initial & Last Name & Degree

Jeannie K Ginnis, DDS, MS

First Name & Middle Initial & Last Name & Degree

John S Preisser, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17518963

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.

Results Reference

background

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Water From Bottles to Establish Strong Teeth

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