Fluoride Administered and Retained After Topical Fluoride Varnish

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01754831

Enrollment

Registered

2012-12-21

Start date

2011-12-31

Completion date

2013-12-31

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

children, fluoride varnish

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.

Detailed description

Fluoride varnish painted on the teeth is the standard method dentists use to prevent tooth decay (cavities) in preschool children in the United States. Fluoride varnish is not FDA approved specifically for prevention of cavities, but dentists may legally use it for this purpose. 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. The fluoride varnish is being used for research purposes for this study by permission of FDA (IND #110869). Premier Dental Product Company's Enamel Pro Varnish will be used. Up to six children aged 12-15 months will be enrolled in this study. We measured urinary fluoride for 5 hours after application of fluoride varnish to teeth. Baseline levels were measured on a separate day.

Interventions

DEVICEFluoride varnish

Topical application of fluoride varnish on present teeth

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 15 Months

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Urinalysis for fluoride levels	2 days	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026