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NCT01754831 · ClinicalTrials.gov registry record · Early Phase 1
Fluoride Administered and Retained After Topical Fluoride Varnish
A Early Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT01754831: Completed Early Phase 1 study, sponsored by University of Washington.
NCT01754831 is a Early Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01754831, a Early Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The specific aim of the study is to determine the excess urinary fluoride and its time course after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15 month old infants. From these data the investigators can estimate the bioavailable (more precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration that will allow an estimate of the margin of safety of the procedure.
Primary Outcome
We want to study how much fluoride appears in the urine after the painting procedure to improve our knowledge of how the varnish works and its safety.
Interventions
- DEVICE Fluoride varnish
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-12 |
| Phase | Early Phase 1 |
What the finished NCT01754831 record still lists
NCT01754831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Fluoride varnish is the first listed.
NCT01754831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01754831 about?
NCT01754831 is a clinical study titled "Fluoride Administered and Retained After Topical Fluoride Varnish". The specific aim of the study is to determine the excess urinary fluoride and its time course after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15 month old infants. From these data the investigators can estimate the bioavailable (more precisely the equivalent) ...
What is the current status of trial NCT01754831?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2011-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01754831?
The interventions under investigation include: Fluoride varnish (DEVICE).
Who is sponsoring clinical trial NCT01754831?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01754831's enrollment target sits among peer trials
6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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