Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries (GIFVT)

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.

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

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.

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)

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.

Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children

Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera

Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.

Caries increment measured by the amount of change in dmfs index from baseline separately by location and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs >0) separately by location. Subgroup analyses will be performed with statistical models which have the location, the intervention group, and their interaction to assess possible effect modification (i.e. moderation).

Caries increment measured by the amount of change in dmfs index from baseline separately by baseline Frankl child behavior score and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs >0) separately by Frankl score. Subgroup analyses will be performed with statistical models which have the baseline Frankl score, the intervention group, and their interaction to assess possible effect modification (i.e. moderation).

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

UCSF DataShare (http://datashare.ucsf.edu) is no longer functional. The Data Dryad repository (https://datadryad.org) will be utilized instead.

Garcia RI, Gregorich SE, Ramos-Gomez F, Braun PA, Wilson A, Albino J, Tiwari T, Harper M, Batliner TS, Rasmussen M, Cheng NF, Santo W, Geltman PL, Henshaw M, Gansky SA. Absence of Fluoride Varnish-Related Adverse Events in Caries Prevention Trials in Young Children, United States. Prev Chronic Dis. 2017 Feb 16;14:E17. doi: 10.5888/pcd14.160372.

Tiwari T, Casciello A, Gansky SA, Henshaw M, Ramos-Gomez F, Rasmussen M, Garcia RI, Albino J, Batliner TS; Early Childhood Caries Collaborating Centers. Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers. Prev Chronic Dis. 2014 Aug 7;11:E133. doi: 10.5888/pcd11.140140.

Garcia RI, Tiwari T, Ramos-Gomez F, Heaton B, Orozco M, Rasmussen M, Braun P, Henshaw M, Borrelli B, Albino J, Diamond C, Gebel C, Batliner TS, Barker JC, Gregorich S, Gansky SA. Retention strategies for health disparities preventive trials: findings from the Early Childhood Caries Collaborating Centers. J Public Health Dent. 2017 Dec;77(1):63-77. doi: 10.1111/jphd.12182. Epub 2016 Oct 19.

Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.