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Fluoride Administered and Retained After Topical Fluoride Varnish

NCT01754831 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-05-07

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DEVICE

Fluoride varnish

Topical application of fluoride varnish on present teeth

Sponsors & Collaborators

Principal Investigators

  • Peter Milgrom, DDS · University of Washington

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-03-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01754831 on ClinicalTrials.gov