Fluoride Varnish Randomized Clinical Trial
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full description
This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
376 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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