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NCT01116739 · ClinicalTrials.gov registry record · Phase 3
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
A Phase 3 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,060
- Enrollment target
NCT01116739: Completed Phase 3 study, sponsored by University of Colorado, Denver.
NCT01116739 is a Phase 3 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 2,060 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116739, a Phase 3 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,060 participants
- Enrollment target
Study Summary
An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measures at 2 years for children in American Indian Head Start Programs.
Primary Outcome
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Interventions
- BEHAVIORAL Oral health education
- DEVICE Fluoride varnish
- OTHER Dental services delivered by the Indian Health Service.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,060 participants |
| Start Date | 2011-04 |
| Est. Completion | 2018-12 |
| Phase | Phase 3 |
What the finished NCT01116739 record still lists
NCT01116739 is an interventional study that assigns participants to a tested intervention. Its 2,060 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (167% higher).
The record links to 0 conditions, and to 3 interventions - of which Oral health education is the first listed.
NCT01116739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116739 about?
NCT01116739 is a clinical study titled "Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs". An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measu...
What is the current status of trial NCT01116739?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,060 participants. The study started on 2011-04. Estimated completion is 2018-12.
What interventions are being tested in trial NCT01116739?
The interventions under investigation include: Oral health education (BEHAVIORAL), Fluoride varnish (DEVICE), Dental services delivered by the Indian Health Service. (OTHER).
Who is sponsoring clinical trial NCT01116739?
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 NCT01116739's enrollment target sits among peer trials
2,060 99th of 2000 higher than 1,902 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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