NCT00066963

Brief Summary

The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Typical duration for phase_3

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

Study Start

First participant enrolled

October 1, 2002

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

May 8, 2012

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

4.1 years

First QC Date

August 7, 2003

Results QC Date

April 5, 2011

Last Update Submit

March 7, 2022

Conditions

Dental Caries

Keywords

Early Childhood Caries

Outcome Measures

Primary Outcomes (1)

  • Number of Caries Incident Cases

    A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.

    two years

Study Arms (3)

Counseling Only

NO INTERVENTION

Counseling Only

FV every 12mo for 24mo + Counsel

EXPERIMENTAL

Preventive fluoride varnish every 12mo for 24mo plus Counseling

Device: Fluoride Varnish

FV every 6mo for 24mo + Counseling

EXPERIMENTAL

Preventive fluoride varnish every 6mo for 24mo plus Counseling

Device: Fluoride Varnish

Interventions

Fluoride VarnishDEVICE

0.1 mL (1 drop) applied on each of 2 arches

Also known as: Duraphat® (Colgate Oral Pharmaceuticals)
FV every 12mo for 24mo + CounselFV every 6mo for 24mo + Counseling

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children \< 44 months old
  • Caries-free
  • erupted maxillary incisors
  • Residing in fluoridated community (San Francisco)

You may not qualify if:

  • Cleft Palate
  • Developmental or learning disabilities
  • Children with transient residence (homeless, migrant, foster home)
  • Children with an another household member participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF School of Dentistry

San Francisco, California, 94143-1361, United States

Location

Related Publications (3)

  • Weintraub JA, Ramos-Gomez F, Jue B, Shain S, Hoover CI, Featherstone JD, Gansky SA. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006 Feb;85(2):172-6. doi: 10.1177/154405910608500211.

    PMID: 16434737RESULT

  • Gansky SA, Cheng NF, Koch GG. Dose-Weighted Adjusted Mantel-Haenszel Tests for Numeric Scaled Strata in a Randomized Trial. Stat Biopharm Res. 2011 May 1;3(2):266-275. doi: 10.1198/sbr.2011.10014.

    PMID: 21709814RESULT

  • Lazar AA, Gansky SA, Halstead DD, Slajs A, Weintraub JA. Improving Patient Care Using the Johnson-Neyman Analysis of Heterogeneity of Treatment Effects According to Individuals' Baseline Characteristics. J Dent Oral Craniofac Epidemiol. 2013 Oct 1;1(3):19-33.

    PMID: 25705704RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Limitations and Caveats

In a protocol deviation, children received placebo varnish for 10 months; this would be expected to bias the study toward the null of no difference among groups. The study did not address FV efficacy for children with extant or past caries.

Results Point of Contact

Title
Stuart Gansky
Organization
Professor, S/D- PREV/REST
stuart.gansky@ucsf.edu
415-502-8094

Study Officials

  • Jane A Weintraub, DDS, MPH

    University of California, San Francisco (now Univ North Carolina)

    PRINCIPAL INVESTIGATOR

  • Francisco Ramos-Gomez, DDS, MPH

    University of California, San Francisco (now Univ Calif Los Angeles)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2003

First Posted

August 8, 2003

Study Start

October 1, 2002

Primary Completion

November 1, 2006

Study Completion

December 1, 2006

Last Updated

March 9, 2022

Results First Posted

May 8, 2012

Record last verified: 2022-03

Locations

US(1)