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| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 7, 2003 |
| Last Updated Date | July 15, 2009 |
| Start Date ICMJE | October 2002 |
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
prevent childhood caries [ Time Frame: Baseline, one-year and two-year visits ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00066963 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Fluoride Varnish Study |
| Official Title ICMJE | Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes |
| Brief Summary | 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). |
| 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 |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Dental Caries |
| Intervention ICMJE | Procedure: Fluoride Varnish |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 371 |
| Completion Date | December 2006 |
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion
Exclusion
|
| Gender | Both |
| Ages | 6 Months to 36 Months |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00066963 |
| Responsible Party | Jane Weintraub, UCSF School of Dentistry |
| Study ID Numbers ICMJE | NIDCR-13058 |
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Dental and Craniofacial Research (NIDCR) |
| Verification Date | July 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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