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NCT01129440 · ClinicalTrials.gov registry record · Phase 2
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 597
- Enrollment target
NCT01129440: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01129440 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 597 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (349% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01129440, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 597 participants
- Enrollment target
Study Summary
The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.
Primary Outcome
Caries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs \>0)
Interventions
- DEVICE Fluoride Varnish
- DEVICE Glass Ionomer Sealant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01129440 record still lists
NCT01129440 is an interventional study that assigns participants to a tested intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (349% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluoride Varnish is the first listed.
NCT01129440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01129440 about?
NCT01129440 is a clinical study titled "Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries". The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlu...
What is the current status of trial NCT01129440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 597 participants. The study started on 2011-06. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01129440?
The interventions under investigation include: Fluoride Varnish (DEVICE), Glass Ionomer Sealant (DEVICE).
Who is sponsoring clinical trial NCT01129440?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01129440's enrollment target sits among peer trials
597 56th of 2000 higher than 1,945 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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