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

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ClinicalTrials.gov Identifier: NCT01129440
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : December 26, 2016
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE May 21, 2010
First Posted Date  ICMJE May 24, 2010
Last Update Posted Date December 26, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
Caries incidence and increment [ Time Frame: Every 12 months (plus or minus 1 month) ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2010)
Caries incidence/increment [ Time Frame: Every 12 months (plus or minus 1 week) ]
Caries incidence/increment measured by the dmfs index between the two groups of randomized children
Change History Complete list of historical versions of study NCT01129440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
  • Caries patterns [ Time Frame: Every 12 months (plus minus 1 month) ]
    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) ]
    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) ]
    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 ]
    Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2010)
  • Caries patterns [ Time Frame: Every 12 months (plus minus 1 week) ]
    Determine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time.
  • Delivery setting [ Time Frame: 36-month follow-up period ]
    Comparison of the impact of delivering interventions at a traditional dental clinic (San Ysidro Health Center) versus a non-traditional dental setting (Comprehensive Health Center - Ocean View)
  • Salivary Fluoride Level [ Time Frame: Every 6 months (plus minus 1 week) ]
    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 week) ]
    Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2014)
  • Effect modification of caries incidence and increment by location [ Time Frame: every 12 months ]
    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 ]
    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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries
Official Title  ICMJE Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Fluoride Varnish
    Topical fluoride varnish (FV) applications every 6 months
    Intervention: Device: Fluoride Varnish
  • 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
    Interventions:
    • Device: Fluoride Varnish
    • Device: Glass Ionomer Sealant
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2013)
597
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2010)
596
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01129440
Other Study ID Numbers  ICMJE NIDCR 09-014-E
U54DE019285 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be shared on UCSF DataShare: http://datashare.ucsf.edu
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Francisco Ramos-Gomez, DDS, MS, MPH University of California, Los Angeles
Principal Investigator: Stuart Gansky, DrPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP