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Completed

NCT Number: NCT01129440

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Ysidro Health Center

San Ysidro, California, 92173, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish

Device

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

Glass Ionomer Sealant

Device

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

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Other outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial

Acronym: GIFVT

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 24, 2010
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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