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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01129440
First received: May 21, 2010
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Dental Caries
Device: Fluoride Varnish
Device: Glass Ionomer Sealant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Caries incidence and increment [ Time Frame: Every 12 months (plus or minus 1 month) ] [ Designated as safety issue: No ]
    Caries increment measured by the amount of change in dmfs index from baseline and caries incidence measured by whether the change in dmfs index increased (ie. change in dmfs >0).


Secondary Outcome Measures:
  • Caries patterns [ Time Frame: Every 12 months (plus minus 1 month) ] [ Designated as safety issue: No ]
    Determine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time.

  • Salivary Fluoride Level [ Time Frame: Every 6 months (plus minus 1 month) ] [ Designated as safety issue: No ]
    Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children

  • Retention of Glass Ionomer Sealants [ Time Frame: Every 12 months (plus minus 1 month) ] [ Designated as safety issue: No ]
    Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera

  • Adverse event [ Time Frame: every 6 months; up to 7 days after application ] [ Designated as safety issue: Yes ]
    Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.


Other Outcome Measures:
  • Effect modification of caries incidence and increment by location [ Time Frame: every 12 months ] [ Designated as safety issue: No ]

    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).


  • Effect modification of caries incidence and increment by baseline Frankl child behavior score [ Time Frame: every 12 months ] [ Designated as safety issue: No ]

    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).



Enrollment: 597
Study Start Date: June 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: GC Fuji TRIAGE CAPSULE and its conditioner

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

Ages Eligible for Study:   2 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129440

Locations
United States, California
San Ysidro Health Center
San Ysidro, California, United States, 92173
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Francisco Ramos-Gomez, DDS, MS, MPH University of California, Los Angeles
Principal Investigator: Stuart Gansky, DrPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01129440     History of Changes
Other Study ID Numbers: NIDCR 09-014-E, U54DE019285
Study First Received: May 21, 2010
Last Updated: July 8, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Children
Fluoride varnish
Glass ionomer sealant
Prevention

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Fluorides
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Cariostatic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014