Dental CariesPhase 3NCT00067353
Yakima Head Start Fluoride Varnish Study
A Phase 3 study testing Fluoride varnish in people with Dental Caries, run by University of Washington at 2 sites in United States.
Trial summary
The aim of this study is to determine whether an annual application of three (3) fluoride varnish doses over two weeks is at least as effective in reducing cavities as the current semi-annual application. Read more about this study
- Who is it for?
- Ages 36 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fluoride varnish
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2003to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 36 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 36-71 months
- Enrolled in participating Head Start Center
- Plan to stay in Yakima County for duration of the study
- One sound tooth surface present
Who cannot join
- No teeth present
- Developmentally unable to give oral assent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Enterprise for Progress in the Community (EPIC) Head Start sites
Lower Valley, Yakima County, Washington, 98902
Washington State Migrant Council Head Start sites
Lower Valley, Yakima County, Washington, 98944
About this study
Official title: Fluoride Varnish Trial in High Caries Preschoolers
The aim of this study is to determine whether an annual application of three (3) fluoride varnish doses over two weeks is at least as effective in reducing cavities as the current semi-annual application.
Read the detailed description
The study population will consist of pre-school aged children who are residents of Yakima County, in central Washington State. Children will be recruited from non-migrant Head Start programs for ethnic minority farmworker children in the Yakima Valley.
This study will be a randomized, double blinded trial with one experimental and one standard treatment group. Each participant will be randomly assigned to one of two study groups. The participant and the personnel conducting the study will not know to which study group the participant was assigned.
This trial has two study groups:
- Massive Dose (Experimental): Annually for three years, children in the experimental group will receive three .30ml applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months later by three .30ml applications of placebo varnish in two weeks. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.
- Semiannual Dose (Standard):
Annually for three years, children in the standard treatment group will receive one .30ml application of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni) and two .30ml applications of placebo varnish in two weeks. They will receive this regimen again 6 months later. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.
Both the experimental and standard treatment children will receive basic restorative dental care on decayed surfaces only, as well as toothbrushes for the duration of the study period. Parents will fill out questionnaires about behaviors such as diet, hygiene and prior dental care. Results will inform future treatment regimens for high-caries-risk populations.
- Conditions
- Dental Caries
- Being tested
- Fluoride varnish
- Keywords
- Early Childhood Caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of decayed, missing, or filled surfaces
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2003 (estimated)
- Study startNov 2003
- Primary completionJul 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), The Yakima Valley Farm Workers Clinic, Enterprise for Progress in the Community, Washington State Migrant Council
- Investigators
- Philip Weinstein, DDS, Principal investigator, Washington State Head Start Sites
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067353
- Sponsor's protocol ID
- NIDCR-14403
- Other IDs
- R01DE014403
- Status last verified
- May 2010
- First submitted
- 15 Aug 2003
- Last updated
- 10 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weinstein P, Spiekerman C, Milgrom P. Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition. Caries Res. 2009;43(6):484-90. doi: 10.1159/000264686. Epub 2009 Dec 10.
PubMed 20016179
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride Varnish Trial in High Caries Preschoolers
- ClinicalTrials.gov ID
- NCT00067353
- Acronym / sponsor ID
- NIDCR-14403
- Conditions
- Dental Caries
- Keywords
- Early Childhood Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), The Yakima Valley Farm Workers Clinic, Enterprise for Progress in the Community, Washington State Migrant Council
- Study start
- Nov 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 19 Aug 2003 (estimated)
- 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 aim of this study is to determine whether an annual application of three (3) fluoride varnish doses over two weeks is at least as effective in reducing cavities as the current semi-annual application.
Detailed description
The study population will consist of pre-school aged children who are residents of Yakima County, in central Washington State. Children will be recruited from non-migrant Head Start programs for ethnic minority farmworker children in the Yakima Valley.
This study will be a randomized, double blinded trial with one experimental and one standard treatment group. Each participant will be randomly assigned to one of two study groups. The participant and the personnel conducting the study will not know to which study group the participant was assigned.
This trial has two study groups:
- Massive Dose (Experimental): Annually for three years, children in the experimental group will receive three .30ml applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months later by three .30ml applications of placebo varnish in two weeks. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.
- Semiannual Dose (Standard):
Annually for three years, children in the standard treatment group will receive one .30ml application of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni) and two .30ml applications of placebo varnish in two weeks. They will receive this regimen again 6 months later. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually.
Both the experimental and standard treatment children will receive basic restorative dental care on decayed surfaces only, as well as toothbrushes for the duration of the study period. Parents will fill out questionnaires about behaviors such as diet, hygiene and prior dental care. Results will inform future treatment regimens for high-caries-risk populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 36-71 months
- Enrolled in participating Head Start Center
- Plan to stay in Yakima County for duration of the study
- One sound tooth surface present
Key exclusion criteria (2 listed)
- No teeth present
- Developmentally unable to give oral assent
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 |
|---|---|---|
| Fluoride varnish | Drug | – |
Primary outcome
Number of decayed, missing, or filled surfaces
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2010.
- Derived from this study: PubMed 20016179Weinstein P, Spiekerman C, Milgrom P. Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition. Caries Res. 2009;43(6):484-90. doi: 10.1159/000264686. Epub 2009 Dec 10.
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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.
Philip Weinstein, DDS principal investigator
Washington State Head Start Sites
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride varnish in people with Dental Caries, run by University of Washington at 2 sites 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of decayed, missing, or filled surfaces. 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 NCT00067353, which also lists 1 linked publication.
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 10 May 2010.