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Home > "F" Clinical Trials Conditions > Fluoride Varnish Study  Fluoride Varnish Study
Fluoride Varnish Study
For Condition: Dental Caries
Status: No longer recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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).
Details: 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
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 6 Months/36 Months
Genders: Both
Protocol Entry 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
Total Enrollment: 371
Location and Contact Information:
UCSF School of Dentistry
San Francisco, California, 94143-1361
United States
Additional Information:
Study ID Numbers: NIDCR-13058;
Study Start Date: October 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066963
Other Dental Caries Studies:
1. Study of the Composition of Dental Plaque
2. Evaluation of Implants Placed Immediately or Delayed into Extraction Sites
3. Fluoride Varnish Study
4. Caries Transmission Prevention in Alaska Native Infants
5. Prevention Management Model for Early Childhood Caries (MAYA Project)
Related Studies:
Other Dental Caries Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Fluoride Varnish Study
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