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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
597
Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
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.
San Ysidro Health Center
San Ysidro, California, United States
Caries Incidence
Caries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs \>0)
Time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Caries Increment
Caries increment by 36 months measured by the amount of change in dmfs index from baseline
Time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Caries Patterns
Determine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time. Occlusal surface dmfs\>0 in baseline eligible molar teeth.
Time frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Salivary Fluoride Level
Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children
Time frame: Every 6 months (plus minus 1 month); Month 30 reported
Retention of Glass Ionomer Sealants
Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera
Time frame: Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported
Adverse Event
Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.
Time frame: every 6 months; up to 7 days after application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.