NCT01129440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 19, 2020

Completed
Last Updated

March 4, 2020

Status Verified

February 1, 2020

Enrollment Period

4.8 years

First QC Date

May 21, 2010

Results QC Date

February 10, 2020

Last Update Submit

February 20, 2020

Conditions

Dental Caries

Keywords

ChildrenFluoride varnishGlass ionomer sealantPrevention

Outcome Measures

Primary Outcomes (2)

  • Caries Incidence

    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

    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 Outcomes (4)

  • Caries Patterns

    Assessed every 12 months (plus or minus 1 month); Month 36 reported

  • Salivary Fluoride Level

    Every 6 months (plus minus 1 month); Month 30 reported

  • Retention of Glass Ionomer Sealants

    Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported

  • Adverse Event

    every 6 months; up to 7 days after application

Other Outcomes (2)

  • Effect Modification of Caries Incidence and Increment by Location

    Assessed every 12 months (plus minus 1 month)

  • Effect Modification of Caries Incidence and Increment by Baseline Frankl Child Behavior Score

    Assessed every 12 months (plus minus 1 month)

Study Arms (2)

Fluoride Varnish

ACTIVE COMPARATOR

Topical fluoride varnish (FV) applications every 6 months

Device: Fluoride Varnish

FV + Glass Ionomer Sealants

EXPERIMENTAL

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 VarnishDevice: Glass Ionomer Sealant

Interventions

Fluoride VarnishDEVICE

Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.

Also known as: 3M ESPE CavityShield® single-dose fluoride varnish units
FV + Glass Ionomer SealantsFluoride Varnish
Glass Ionomer SealantDEVICE

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.

Also known as: GC Fuji TRIAGE CAPSULE and its conditioner
FV + Glass Ionomer Sealants

Eligibility Criteria

Age2 Years - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Ysidro Health Center

San Ysidro, California, 92173, United States

Location

Related Publications (4)

  • 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.

    PMID: 28207379RESULT

  • 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.

    PMID: 25101490RESULT

  • 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.

    PMID: 27759164RESULT

  • 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.

    PMID: 28526003DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr. Stuart Gansky
Organization
University of California, San Francisco
stuart.gansky@ucsf.edu
415-502-8094

Study Officials

  • Francisco Ramos-Gomez, DDS, MS, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Stuart Gansky, DrPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 24, 2010

Study Start

June 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 4, 2020

Results First Posted

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)