NCT01629290

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

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

June 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 22, 2017

Completed
Last Updated

May 22, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

June 10, 2012

Results QC Date

February 1, 2017

Last Update Submit

April 9, 2017

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Fluoride Concentration and Release

    Fluoride release as measured by concentration of fluoride available in the oral cavity at different time periods after the application of 5% NaF varnish and placebo as measured in unstimulated human saliva

    Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs

Study Arms (4)

Enamel Pro

ACTIVE COMPARATOR

Varnish containing 5%NaF

Device: Enamel Pro

Duraphat

ACTIVE COMPARATOR

Varnish containing 5%NaF

Device: Duraphat

Vanish

ACTIVE COMPARATOR

Varnish containing 5%NaF

Device: Vanish

Placebo

PLACEBO COMPARATOR

Bland varnish containing no NaF

Device: Placebo

Interventions

Enamel ProDEVICE

Varnish treatment containing 5% NaF

Also known as: Varnish
Enamel Pro
DuraphatDEVICE

Varnish treatment containing 5% NaF

Also known as: Varnish
Duraphat
VanishDEVICE

Varnish treatment containing 5% NaF

Also known as: Varnish
Vanish
PlaceboDEVICE

Bland varnish containing no NaF

Also known as: Bland varnish
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Subjects with less than 20 teeth
  • Subjects with significant untreated disease to include gum disease, extensive decay, or the need for pre-medication prior to dental treatment
  • Pregnant or lactating women
  • Subjects with a history of allergy to materials to be used in the study
  • Subjects unable to produce adequate saliva for sampling
  • Subjects deemed low risk for dental caries (no history of restorative work or presence of caries lesions)
  • Subjects unable to be available for all 4 cycles of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (1)

  • Downey D, Dennison J, Eckert GJ, Flannagan SE, Neiva GF, Yaman P, Gonzalez-Cabezas C. Fluoride Levels in Unstimulated Whole Saliva following Clinical Application of Different 5% NaF Varnishes. Caries Res. 2018;52(6):431-438. doi: 10.1159/000485981. Epub 2018 Apr 3.

    PMID: 29614502DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Cavity Lining

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistry

Results Point of Contact

Title
Danika Downey, DDS
Organization
University of Michigan School of Dentistry
danika.downey@gmail.com
330-877-8783

Study Officials

  • Peter Yaman, DDS, MS

    University of Michigan

    STUDY CHAIR

  • Gisele Neiva, DDS, MS

    University of Michigan School of Dentsitry

    STUDY CHAIR

  • Joseph Dennison, DDS, MS

    University of Michigan

    STUDY CHAIR

  • Carlos Gonzalez, DDS,MSD,PhD

    University of Michigan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student, Restorative Dentistry

Study Record Dates

First Submitted

June 10, 2012

First Posted

June 27, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 22, 2017

Results First Posted

May 22, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)