Phase 3
N=376
Fluoride Varnish Randomized Clinical Trial
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT00066963 ↗Enrolled (actual)
376
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Number of Caries Incident Cases — 42; 23; 14 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluoride Varnish (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Caries Incident Cases |
42; 23; 14 | <0.001 sig |
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).
Eligibility Criteria
Inclusion
- Children < 44 months old
- Caries-free
- 4 erupted maxillary incisors
- Residing in fluoridated community (San Francisco)
Exclusion
- Cleft Palate
- Developmental or learning disabilities
- Children with transient residence (homeless, migrant, foster home)
- Children with an another household member participating in the study
Data sourced from ClinicalTrials.gov (NCT00066963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.