Dental CariesNCT01629290

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

A study testing Enamel Pro, Duraphat and Vanish in people with Dental Caries, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: Enamel Pro, Duraphat and Vanish
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All subjects between 18-65 years of age and do not fall under any of the exclusion criteria

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan School of Dentistry
Ann Arbor, Michigan, 48104

Other trials in United States

About this study

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.

Read the detailed description

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. Subjects will be recruited at the University of Michigan School of Dentistry and will participate in a 15 minute clinical session at the beginning of each study arm, followed by 6 saliva collection recalls. During these sessions a fluoride varnish or placebo will be applied to their teeth, and subsequent salivary samples will be taken 1 hour, 4 hours, 6 hours, 24 hours, and 48 hours after the application. All subjects will receive 3 commercially available varnishes, and a placebo varnish. Between applications there will be a minimum of 2 weeks wash-out period. 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.

Specific Aims

Determine the concentration of fluoride available in the oral cavity at different time periods after the application of three different 5% NaF varnishes as measured in unstimulated human saliva.
Compare the different patterns of fluoride release from each of the varnishes by comparing the fluoride concentration in saliva at corresponding time periods .
Evaluate the validity of an in vitro model used to measure fluoride release from varnishes.

Percentage difference in fluoride release between the in vivo and in vitro data obtained from the same products will be compared. Because the comparison of different patterns of fluoride release from the varnishes is accomplished by analyzing the fluoride available concentration levels, it was an error to list that secondary aim as a secondary - or indeed any sort of outcome measure. The outcome measure data for "patterns of fluoride release" is exactly that which has been fully disclosed in the Primary Outcome Measure data tables. Therefore the secondary outcome measure previously listed: Compare the different patterns of fluoride release from each of the varnishes, which was really never properly an outcome measure, but an aim, has been deleted, with no loss of data transparency.

Conditions: Dental Caries
Being tested: Enamel Pro, Duraphat, Vanish, Placebo
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enamel ProDevice
Also called Varnish
Varnish treatment containing 5% NaF
DuraphatDevice
Also called Varnish
Varnish treatment containing 5% NaF
VanishDevice
Also called Varnish
Varnish treatment containing 5% NaF
PlaceboDevice
Also called Bland varnish
Bland varnish containing no NaF

Study groups in NCT01629290
Study group	Role	What they receive
Enamel Pro	Active comparator	Varnish containing 5%NaF Receives: Device: Enamel Pro
Duraphat	Active comparator	Varnish containing 5%NaF Receives: Device: Duraphat
Vanish	Active comparator	Varnish containing 5%NaF Receives: Device: Vanish
Placebo	Placebo comparator	Bland varnish containing no NaF Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Dec 2015

First posted27 Jun 2012 (estimated)
Study startJun 2012
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental CariesStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01629290
Sponsor's protocol ID: HUM00062943
Status last verified: Apr 2017
First submitted: 10 Jun 2012
Last updated: 22 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 29614502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes
ClinicalTrials.gov ID: NCT01629290
Acronym / sponsor ID: HUM00062943
Conditions: Dental Caries
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Delta Dental Fund of Michigan
Study start: Jun 2012
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 27 Jun 2012 (estimated)
Results: Posted 22 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aims

Determine the concentration of fluoride available in the oral cavity at different time periods after the application of three different 5% NaF varnishes as measured in unstimulated human saliva.
Compare the different patterns of fluoride release from each of the varnishes by comparing the fluoride concentration in saliva at corresponding time periods .
Evaluate the validity of an in vitro model used to measure fluoride release from varnishes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Enamel Pro	Active comparator	Device: Enamel ProVarnish containing 5%NaF
Duraphat	Active comparator	Device: DuraphatVarnish containing 5%NaF
Vanish	Active comparator	Device: VanishVarnish containing 5%NaF
Placebo	Placebo comparator	Device: PlaceboBland varnish containing no NaF

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All subjects between 18-65 years of age and do not fall under any of the exclusion criteria

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enamel ProAlso: VarnishVarnish treatment containing 5% NaF	Device	Enamel Pro
DuraphatAlso: VarnishVarnish treatment containing 5% NaF	Device	Duraphat
VanishAlso: VarnishVarnish treatment containing 5% NaF	Device	Vanish
PlaceboAlso: Bland varnishBland varnish containing no NaF	Device	Placebo

Primary outcome

Fluoride Concentration and Release
Time frame: Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs
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

Results and safety

Results posted to the registry on 22 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varnishes and Placebo	15	15

Primary outcome: Fluoride Concentration and Release

Time frame: Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs. Mean (Standard Deviation). Unit: ppm

Measure	Enamel Pro n = 15	Duraphat n = 15	Vanish n = 15	Placebo n = 15
Baseline	.09 (.07)	.07 (.04)	.09 (.07)	.09 (.08)
1 hr following application	6.19 (4.09)	18.94 (9.95)	19.78 (14.57)	.02 (.02)
4 hrs following application	.67 (.36)	3.39 (4.83)	4.12 (3.80)	.01 (.01)
6 hrs following application	.37 (.2)	1.82 (1.98)	1.15 (.79)	.03 (.04)
26 hrs following application	.4 (.02)	.19 (.15)	.2 (.33)	.02 (.04)
50 hrs following application	.02 (.03)	.04 (.03)	.02 (.03)	.01 (.01)

Population analysed: The 15 participants were each involved in each of the successive treatments with Enamel Pro, Duraphat, Vanish, and Placebo, (the order differed for each participant), and to show the differences between baseline and the different treatment levels, the baselines before each of the treatments is listed here along with the relevant treatment.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enamel Pro	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Placebo	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Duraphat	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Vanish	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29614502Downey 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Yaman, DDS, MS study chair

University of Michigan

Gisele Neiva, DDS, MS study chair

University of Michigan School of Dentsitry

Joseph Dennison, DDS, MS study chair

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enamel Pro, Duraphat and Vanish in people with Dental Caries, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluoride Concentration and Release (time frame: Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01629290, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.