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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 is a Phase 3 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 2,060 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01116739
The ClinicalTrials.gov registry entry for NCT01116739 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,060 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Oral health education is the first listed.
NCT01116739 reports 0 study locations.
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.
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