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San Francisco, California 94143


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

Study summary:

This project has two components that employ different research designs and study populations to enhance our understanding and ability to prevent early childhood caries. Both the health services research and clinical research components will determine if certain factors are associated with increased ECC incidence, but involve very different study population. The first component is a population-based retrospective cohort study among 6,058 children born between 1986-1993 to members of the Kaiser Permanente Health Plan in the Pacific Northwest (KPNW). Factors to be assessed from KPNW patient records include information about the child, the parents, the mother (i.e., medications prescribed to the mother during pregnancy), the siblings, and the dental provider. Behavioral information will be ascertained from questionnaires. Few other settings can provide information of all new ECC cases in a known population and link medical, dental, and pharmaceutical information with information on dental utilization and cost of services. The second component is 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 will 1) Compare the efficacy of once or twice/year fluoride varnish application and counseling to counseling alone in preventing ECC; 2) Assess pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compare the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determine the salivary fluoride release profile following exposure to fluoride varnish. If successful, this study will provide methods for targeting children at risk for ECC and evidence that an intervention is efficacious in preventing ECC in this young age group


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



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Location Contact:

San Francisco, California 94143
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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