Dental Caries in ChildrenwaterBESTNCT04893681
Water From Bottles to Establish Strong Teeth
A study testing Fluoridated bottled drinking water and Non-fluoridated drinking water in people with Dental Caries in Children, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Fluoridated bottled drinking water and Non-fluoridated drinking water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Pediatric and Public Health, UNC Adams School of Dentistry
Chapel Hill, North Carolina, 27599-7455
About this study
Official title: Proof-of-concept Randomized Controlled Trial to Evaluate Dental Caries Preventive Effects of Fluoridated Bottled Water
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.
Read the 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.
- Conditions
- Dental Caries in Children
- Being tested
- Fluoridated bottled drinking water, Non-fluoridated drinking water
- Keywords
- Fluorides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoridated bottled drinking waterOther
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 drinking waterOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Non-fluoridated drinking water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Dental examination in year 4
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start14 Apr 2022
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomized, double-masked, placebo controlled, parallel group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Gary Slade, BDSc, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893681
- Sponsor's protocol ID
- 20-3273
- Other IDs
- UG3DE029169, 21-017-E
- Acronym
- waterBEST
- Status last verified
- Jun 2026
- First submitted
- 7 May 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17518963Sanders 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.
PubMed 38443989
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Randomized Controlled Trial to Evaluate Dental Caries Preventive Effects of Fluoridated Bottled Water
- ClinicalTrials.gov ID
- NCT04893681
- Acronym / sponsor ID
- waterBEST / 20-3273
- Conditions
- Dental Caries in Children
- Keywords
- Fluorides
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Tulane University, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Block randomized, double-masked, placebo controlled, parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Fluoridated bottle water | Experimental | Other: Fluoridated bottled drinking water5-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 |
| Non-fluoridated bottled water | Placebo comparator | Other: Non-fluoridated drinking water5-gallon bottles containing water from the North Lenoir Water Corporation's Black Creek aquifer which contains a negligible concentration of fluoride. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoridated bottled drinking waterStudy 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. | Other | Fluoridated bottle water |
| Non-fluoridated drinking waterStudy 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. | Other | Non-fluoridated bottled water |
Primary outcome
dmfs index
Time frame: Dental examination in year 4
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".
2 secondary outcomes
Fluoride content of fingernail and toenail biospecimens
Time frame: Up to three years after randomization.
Adverse events
Time frame: Through study completion, an average of 42 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 17518963Ismail 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.
- Derived from this study: PubMed 38443989Sanders 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.
- Individual participant dataSharing planned: No
Related trials for Dental Caries in Children
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
Recruiting
Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents
Caries Risk, Caries, Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Slade, BDSc, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoridated bottled drinking water and Non-fluoridated drinking water in people with Dental Caries in Children, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dmfs index (time frame: Dental examination in year 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893681, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.