Clinical trial NCT01129440: Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
Official title: Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: Children
Fluoride varnish
Glass ionomer sealant
Prevention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-05-24
Enrollment: 597
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 criteria: 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

Primary outcomes:
measure: Caries Incidence
timeFrame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
measure: Caries Increment
timeFrame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Secondary outcomes:
measure: Caries Patterns
timeFrame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
measure: Salivary Fluoride Level
timeFrame: Every 6 months (plus minus 1 month); Month 30 reported
measure: Retention of Glass Ionomer Sealants
timeFrame: Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported
measure: Adverse Event
timeFrame: every 6 months; up to 7 days after application
Other outcomes:
measure: Effect Modification of Caries Incidence and Increment by Location
timeFrame: Assessed every 12 months (plus minus 1 month)
measure: Effect Modification of Caries Incidence and Increment by Baseline Frankl Child Behavior Score
timeFrame: Assessed every 12 months (plus minus 1 month)
Locations:
city: San Ysidro
country: United States
facility: San Ysidro Health Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Francisco Ramos-Gomez, DDS, MS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Stuart Gansky, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.