Phase 2
N=597
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01129440 ↗Enrolled (actual)
597
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Caries Incidence — 137; 123 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoride Varnish (Device); Glass Ionomer Sealant (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caries Incidence |
137; 123 | — |
| PRIMARY Caries Increment |
4.9; 4.1 | — |
| SECONDARY Caries Patterns |
117; 106 | — |
| SECONDARY Salivary Fluoride Level |
0.072; 0.128 | — |
| SECONDARY Retention of Glass Ionomer Sealants |
249 | — |
| SECONDARY Adverse Event |
0; 1 | — |
Summary
The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.
Eligibility Criteria
Inclusion Criteria
- Family resides in the South Bay or Central San Diego area
- Parent/Guardian can consent in English or Spanish
- Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no restoration)
- Child is cooperative and behaviorally suited for the clinical trial interventions
- Child is a registered patient at San Ysidro Health Center Inc.
Exclusion Criteria
- Any siblings of participants
- Child with cavitated lesions
- Child with a health condition, special need, or with a complicated factor that will prevent from completing the required number of visits during a 36-month follow-up period
- Anything, that in the opinion of the investigator, would preclude the child from complying with the protocol or jeopardize the safety of the child while on the protocol
Data sourced from ClinicalTrials.gov (NCT01129440). 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.