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Fluoride Varnish Study
This study has been completed.
First Received: August 7, 2003   Last Updated: July 15, 2009   History of Changes
Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00066963
  Purpose

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).


Condition Intervention Phase
Dental Caries
Procedure: Fluoride Varnish
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

Resource links provided by NLM:


Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • prevent childhood caries [ Time Frame: Baseline, one-year and two-year visits ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: October 2002
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Fluoride Varnish
    Fluoride Varnish
Detailed Description:

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

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066963

Locations
United States, California
UCSF School of Dentistry
San Francisco, California, United States, 94143-1361
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: UCSF School of Dentistry ( Jane Weintraub )
Study ID Numbers: NIDCR-13058
Study First Received: August 7, 2003
Last Updated: July 15, 2009
ClinicalTrials.gov Identifier: NCT00066963     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):
Early Childhood Caries

Additional relevant MeSH terms:
Fluorides, Topical
Tooth Diseases
Cariostatic Agents
Physiological Effects of Drugs
Stomatognathic Diseases
Fluorides
Protective Agents
Pharmacologic Actions
Tooth Demineralization
Dental Caries

ClinicalTrials.gov processed this record on November 27, 2009