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In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes

NCT01629290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-05-22

Study results available
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Summary

This study will be a cross-over single blinded clinical study to evaluate the in vitro fluoride release of three different brands of 5% NaF varnish. The goal of this study is to determine if different formulations of varnish lead to differing amounts of fluoride release. Despite their similar concentrations of NaF (5%), some in vitro data have suggested that they may differ in the amount of fluoride release. Determining fluoride release of these varnishes in vivo is important in assessing both the safety and efficacy of the product.

Conditions

  • Dental Caries

Interventions

DEVICE

Enamel Pro

Varnish treatment containing 5% NaF

DEVICE

Duraphat

Varnish treatment containing 5% NaF

DEVICE

Vanish

Varnish treatment containing 5% NaF

DEVICE

Placebo

Bland varnish containing no NaF

Sponsors & Collaborators

Principal Investigators

  • Peter Yaman, DDS, MS · University of Michigan

  • Gisele Neiva, DDS, MS · University of Michigan School of Dentsitry

  • Joseph Dennison, DDS, MS · University of Michigan

  • Carlos Gonzalez, DDS,MSD,PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-12-31
Completion
2015-12-31
FDA Device
Yes

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 NCT01629290 on ClinicalTrials.gov