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NCT04002232 · ClinicalTrials.gov registry record · Early Phase 1
Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish
A Early Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT04002232: Completed Early Phase 1 study, sponsored by University of Colorado, Denver.
NCT04002232 is a Early Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04002232, a Early Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Sometimes when people wear braces, the combination of dental plaque and diets high in sugar and acids can lead to white spots on the teeth surrounding the braces. These are commonly found in people with braces depending on their diet and care of their teeth. The white spots will still be present when the braces are removed. These white spots are the beginning signs of cavities and show that mineral has been lost from the tooth. This study will be testing a new varnish that is painted on the tooth around the braces to prevent these white spots from forming. This study will enroll patients who wear braces and have planned teeth extractions. A calcium and fluoride releasing varnish will be painted on the teeth planned to be extracted. Braces will then be placed on the teeth. In 3-6 weeks, the extraction will occur and the teeth will be collected for analysis.
Primary Outcome
mineral density as determined by micro computed tomography (uCT)
Interventions
- DEVICE CPP-ACP-NaF varnish
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-07-12 |
| Est. Completion | 2019-12-05 |
| Phase | Early Phase 1 |
What the finished NCT04002232 record still lists
NCT04002232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which CPP-ACP-NaF varnish is the first listed.
NCT04002232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04002232 about?
NCT04002232 is a clinical study titled "Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish". Sometimes when people wear braces, the combination of dental plaque and diets high in sugar and acids can lead to white spots on the teeth surrounding the braces. These are commonly found in people with braces depending on their diet and care of their teeth. The white spots will still be present whe...
What is the current status of trial NCT04002232?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2019-07-12. Estimated completion is 2019-12-05.
What interventions are being tested in trial NCT04002232?
The interventions under investigation include: CPP-ACP-NaF varnish (DEVICE).
Who is sponsoring clinical trial NCT04002232?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04002232's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 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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