CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,060 enrolled
Drug / intervention
Fluoride varnish +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01116739
NCT01116739Phase 3Completed

Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs

University of Colorado, Denver·interventional·Posted May 5, 2010·Updated Jun 10, 2021

In Brief

A Phase 3 clinical trial evaluating Fluoride varnish, Oral health education, and 1 other intervention for Fluoride Varnish and Oral Health Promotion and Usual Care. Completed, enrolled 2,060 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2010
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 16.2 years ago

Interventions

Fluoride varnishdevice

Fluoride varnish will be administered by the COHS quarterly for 2 years.

Oral health educationbehavioral

Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.

Dental services delivered by the Indian Health Service.other