Full Text View
Tabular View
No Study Results Posted
Related Studies
Fluoride Varnish Study
This study has been completed.
Study NCT00066963   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: August 7, 2003   Last Updated: July 15, 2009   History of Changes

August 7, 2003
July 15, 2009
October 2002
November 2006   (final data collection date for primary outcome measure)
prevent childhood caries [ Time Frame: Baseline, one-year and two-year visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00066963 on ClinicalTrials.gov Archive Site
 
 
 
Fluoride Varnish Study
Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

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).

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

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Dental Caries
Procedure: Fluoride Varnish
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
371
December 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
6 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066963
Jane Weintraub, UCSF School of Dentistry
NIDCR-13058
National Institute of Dental and Craniofacial Research (NIDCR)
 
 
National Institute of Dental and Craniofacial Research (NIDCR)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP