NCT01754831

Brief Summary

The specific aim of the study is to determine the excess urinary fluoride and its time course after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15 month old infants. From these data the investigators can estimate the bioavailable (more precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration that will allow an estimate of the margin of safety of the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for early_phase_1 healthy

Timeline
Completed

Started Dec 2011

Longer than P75 for early_phase_1 healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

October 10, 2012

Last Update Submit

May 1, 2018

Conditions

Healthy

Keywords

childrenfluoride varnish

Outcome Measures

Primary Outcomes (1)

  • Urinalysis for fluoride levels

    We want to study how much fluoride appears in the urine after the painting procedure to improve our knowledge of how the varnish works and its safety.

    2 days

Study Arms (1)

Fluoride varnish

OTHER

Topical fluoride

Device: Fluoride varnish

Interventions

Fluoride varnishDEVICE

Topical application of fluoride varnish on present teeth

Also known as: Premier Enamel Pro
Fluoride varnish

Eligibility Criteria

Age12 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • consent obtained from parent or legal guardian of participant
  • children aged 12 - 15 months
  • at least 1 erupted tooth
  • in general good health

You may not qualify if:

  • known allergy to any drug, latex, nuts, or resin components or components of toothpaste/dental prophylaxis product
  • participant has stomatitis or other oral conditions that preclude applying fluoride varnish comfortably

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

Location

Related Publications (1)

  • Milgrom P, Taves DM, Kim AS, Watson GE, Horst JA. Pharmacokinetics of fluoride in toddlers after application of 5% sodium fluoride dental varnish. Pediatrics. 2014 Sep;134(3):e870-4. doi: 10.1542/peds.2013-3501. Epub 2014 Aug 18.

    PMID: 25136045BACKGROUND

Study Officials

  • Peter Milgrom, DDS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2012

First Posted

December 21, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

May 7, 2018

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)