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

February 20, 2020 updated by: University of California, San Francisco

Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

597

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Ysidro, California, United States, 92173
        • San Ysidro Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • GC Fuji TRIAGE CAPSULE and its conditioner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries Incidence
Time Frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
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)
Assessed every 12 months (plus or minus 1 month); Month 36 reported
Caries Increment
Time Frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Caries increment by 36 months measured by the amount of change in dmfs index from baseline
Assessed every 12 months (plus or minus 1 month); Month 36 reported

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries Patterns
Time Frame: Assessed every 12 months (plus or minus 1 month); Month 36 reported

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.
Assessed every 12 months (plus or minus 1 month); Month 36 reported
Salivary Fluoride Level
Time Frame: Every 6 months (plus minus 1 month); Month 30 reported
Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children
Every 6 months (plus minus 1 month); Month 30 reported
Retention of Glass Ionomer Sealants
Time Frame: Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported
Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera
Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported
Adverse Event
Time Frame: every 6 months; up to 7 days after application
Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.
every 6 months; up to 7 days after application

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect Modification of Caries Incidence and Increment by Location
Time Frame: Assessed every 12 months (plus minus 1 month)

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).
Assessed every 12 months (plus minus 1 month)
Effect Modification of Caries Incidence and Increment by Baseline Frankl Child Behavior Score
Time Frame: Assessed every 12 months (plus minus 1 month)

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).
Assessed every 12 months (plus minus 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (ESTIMATE)

May 24, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR 09-014-E
  • U54DE019285 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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