Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries (GIFVT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Caries |
Device: Fluoride Varnish Device: Glass Ionomer Sealant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial |
- 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).
- Caries patterns [ Time Frame: Every 12 months (plus minus 1 month) ] [ Designated as safety issue: No ]Determine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time.
- Salivary Fluoride Level [ Time Frame: Every 6 months (plus minus 1 month) ] [ Designated as safety issue: No ]Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children
- Retention of Glass Ionomer Sealants [ Time Frame: Every 12 months (plus minus 1 month) ] [ Designated as safety issue: No ]Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera
| Enrollment: | 597 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Fluoride Varnish
Topical fluoride varnish (FV) applications every 6 months
|
Device: Fluoride Varnish
Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Other Name: 3M ESPE CavityShield® single-dose fluoride varnish units
|
|
Experimental: FV + Glass Ionomer Sealants
Topical fluoride varnish (FV) applications every 6 months, and fluoride-releasing glass ionomer sealants (GIS) placed on primary molars at baseline and annually, as needed
|
Device: Fluoride Varnish
Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
Other Name: 3M ESPE CavityShield® single-dose fluoride varnish units
Device: Glass Ionomer Sealant
Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material. After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar. Other Name: GC Fuji TRIAGE CAPSULE and its conditioner
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Family resides in the South Bay or Central San Diego area
- Parent/Guardian can consent in English or Spanish
- Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no restoration)
- Child is cooperative and behaviorally suited for the clinical trial interventions
- Child is a registered patient at San Ysidro Health Center Inc.
Exclusion Criteria:
- Any siblings of participants
- Child with cavitated lesions
- Child with a health condition, special need, or with a complicated factor that will prevent from completing the required number of visits during a 36-month follow-up period
- Anything, that in the opinion of the investigator, would preclude the child from complying with the protocol or jeopardize the safety of the child while on the protocol
Contacts and Locations| United States, California | |
| San Ysidro Health Center | |
| San Ysidro, California, United States, 92173 | |
| Principal Investigator: | Francisco Ramos-Gomez, DDS, MS, MPH | University of California, Los Angeles |
| Principal Investigator: | Stuart Gansky, DrPH | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | Stuart Gansky, Professor, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01129440 History of Changes |
| Other Study ID Numbers: | NIDCR 09-014-E, U54DE019285 |
| Study First Received: | May 21, 2010 |
| Last Updated: | January 21, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Francisco:
|
Children Fluoride varnish Glass ionomer sealant Prevention |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Amphetamine Methamphetamine Fluorides, Topical Fluorides Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Cariostatic Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013