Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries (GIFVT)
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| First Received Date ICMJE | May 21, 2010 | ||||||||
| Last Updated Date | January 21, 2013 | ||||||||
| Start Date ICMJE | June 2011 | ||||||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Caries incidence and increment [ Time Frame: Every 12 months (plus or minus 1 month) ] [ Designated as safety issue: No ] Caries increment measured by the amount of change in dmfs index from baseline and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs >0). |
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| Original Primary Outcome Measures ICMJE |
Caries incidence/increment [ Time Frame: Every 12 months (plus or minus 1 week) ] [ Designated as safety issue: No ] Caries incidence/increment measured by the dmfs index between the two groups of randomized children |
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| Change History | Complete list of historical versions of study NCT01129440 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries | ||||||||
| Official Title ICMJE | Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial | ||||||||
| Brief Summary | The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children. |
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| Detailed Description | Community-based, stratified (by location) randomized clinical trial (RCT) to determine the relative efficacy of topically applied fluoride varnish (FV) applications alone vs FV with fluoride-releasing glass ionomer (GI) sealants on occlusal surfaces of primary molars in reducing the caries incidence and increment in 3-6 year old children. A parallel groups design RCT stratified by study site (one dental and one non-dental location) will be conducted among 596 initially 2.5- to 3-year-old children. Those eligible will be randomized to one of 2 groups (FV or GIS+FV) and followed for 36 months. The RCT will take place at two sites serving primarily underserved, minority and low-income populations in Southern California: 1) the dental facility of the San Ysidro Health Center (SYHC) located near the U.S.-Mexican Border serves mainly Latino immigrants, and 2) the Comprehensive Health Center - Ocean View (CHC-OV), in a non-dental setting in close proximity to its dental clinic, which serves Latinos and African Americans. Both sites are part of a consortium of community clinics (SYHC Inc) and are located 15 miles apart from each other. Annual study dental examinations will be performed by trained, calibrated, study dentists to determine caries (precavitated and cavitated) incidence and increment. Children identified as needing dental care will be referred for appropriate treatment. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Dental Caries | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 597 | ||||||||
| Estimated Completion Date | February 2016 | ||||||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 2 Years to 3 Years | ||||||||
| 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 Number ICMJE | NCT01129440 | ||||||||
| Other Study ID Numbers ICMJE | NIDCR 09-014-E, U54DE019285 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Stuart Gansky, University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | January 2013 | ||||||||
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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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