CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 376 enrolled
Drug / intervention
Fluoride Varnishdevice
Likely dose
Fluoride varnish 0.1 mL (1 drop) applied to each of 2 archesAI-extracted
Key inclusion· 4
  • ✓Age under 44 months
  • ✓Currently caries-free (no existing cavities)
  • ✓At least 4 erupted maxillary (upper front) incisors
  • ✓Residing in a fluoridated community (San Francisco)
Key exclusion· 4
  • ✕Cleft palate
  • ✕Developmental or learning disabilities
  • ✕Transient residence (homeless, migrant, or foster care status)
  • ✕Another household member enrolled in the study

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

Search/NCT00066963
NCT00066963Phase 3Completed
CompareCT.gov

Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

University of California, San Francisco·interventional·Posted Aug 8, 2003·Updated Mar 9, 2022

In Brief

A Phase 3 clinical trial evaluating Fluoride Varnish for Dental Caries. Completed, enrolled 376 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2003
Enrollment StartOct 1, 2002
Primary CompletionNov 1, 2006
Study CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 22.9 years ago

Interventions

Fluoride Varnishdevice

0.1 mL (1 drop) applied on each of 2 arches