Pharmacokinetics of Advantage Anti-Caries Varnish

A Phase 2 study testing Anti-caries varnish in people with Dental Caries, run by Advantage Silver Dental Arrest, LLC.

Completed

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

Trial summary

The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: Anti-caries varnish
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: No sites listed yet
Study dates: 1 Nov 2016to 25 Apr 2018
Phase: Phase 2
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.

Who cannot join

Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions, sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism, hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular thread with heart disease, multi nodular goiter, Graves disease, or autoimmune thyroiditis

About this study

The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.

Read the detailed description

The study was to characterize serum iodine and fluoride levels over 24 hours after application of a topical dental varnish in healthy adults 23 to 57 years old.

Conditions: Dental Caries
Being tested: Anti-caries varnish
Keywords: adults, povidone iodine, sodium fluoride
Medical subject headings: Dental Caries

What participants receive

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

Anti-caries varnishDrug
topical tooth varnish

Study groups in NCT04183231
Study group	Role	What they receive
Anti-caries varnish	Experimental	topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Receives: Drug: Anti-caries varnish

What is being measured

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

Observed Iodine Tmax
Time to maximum serum concentration of iodine in hours
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Iodine Cmax
Maximum serum concentration of iodine in ng/mL
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Iodine Baseline-Corrected Cmax
Maximum serum concentration of iodine in ng/mL
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Iodine Baseline-Corrected AUC
Area under the Curve for observed iodine in ng*h/mL
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Iodine Total Urinary Recovery
Total urinary recovery in milligrams observed
Measured: baseline to 24 hours
Iodine t1/2
Terminal elimination half-life of iodine in hours
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Fluoride Tmax
Time to maximum serum concentration in hours
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Fluoride Cmax
Maximum serum concentration of fluoride in ng/mL
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Fluoride Baseline-Corrected Cmax
Maximum serum concentration of iodine in ng/mL
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Fluoride AUC
Area under the Curve for observed fluoride in ng*h/mL
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Fluoride Baseline-Corrected AUC
Area under the Curve for observed fluoride in ng*h/mL
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Fluoride t1/2
Terminal elimination half-life in hours for fluoride
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Observed Fluoride Total Urinary Recovery
Total urinary recovery in milligrams observed
Measured: baseline to 24 hours

Timeline

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

1 Nov 201625 Apr 2018

First posted3 Dec 2019
Study start1 Nov 2016
Primary completion28 Feb 2017
Study completion25 Apr 2018

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.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open label exposure--response study
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04183231
Sponsor's protocol ID: 2016-04-05
Status last verified: Jul 2020
First submitted: 27 Nov 2019
Last updated: 21 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of Iodine and Fluoride following Application of an Anticaries Varnish in Adults. JDR Clin Trans Res. 2018 Jul;3(3):238-245. doi: 10.1177/2380084418771930. Epub 2018 Apr 25.
PubMed 30938600

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?

Official record

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All Dental Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Advantage Anti-Caries Varnish
ClinicalTrials.gov ID: NCT04183231
Acronym / sponsor ID: 2016-04-05
Conditions: Dental Caries
Keywords: adults, povidone iodine, sodium fluoride
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Advantage Silver Dental Arrest, LLCIndustry (pharma, biotech, devices)
Collaborators: University of Washington
Study start: 1 Nov 2016 (actual)
Primary completion: 28 Feb 2017 (actual)
Study completion: 25 Apr 2018 (actual)
First posted: 3 Dec 2019 (actual)
Results: Posted 21 Aug 2020

Clinical summary

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

The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.

Detailed description

The study was to characterize serum iodine and fluoride levels over 24 hours after application of a topical dental varnish in healthy adults 23 to 57 years old.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open label exposure--response study

Arm	Type	Receives
Anti-caries varnish	Experimental	Drug: Anti-caries varnishtopical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.

Key exclusion criteria (1 listed)

Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions, sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism, hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular thread with heart disease, multi nodular goiter, Graves disease, or autoimmune thyroiditis

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
Anti-caries varnishtopical tooth varnish	Drug	Anti-caries varnish

Primary outcome

Observed Iodine Tmax
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to maximum serum concentration of iodine in hours
Observed Iodine Cmax
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
Observed Iodine Baseline-Corrected Cmax
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
Observed Iodine Baseline-Corrected AUC
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Area under the Curve for observed iodine in ng*h/mL
Observed Iodine Total Urinary Recovery
Time frame: baseline to 24 hours
Total urinary recovery in milligrams observed
Iodine t1/2
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Terminal elimination half-life of iodine in hours
Observed Fluoride Tmax
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to maximum serum concentration in hours
Observed Fluoride Cmax
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of fluoride in ng/mL
Observed Fluoride Baseline-Corrected Cmax
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
Observed Fluoride AUC
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Area under the Curve for observed fluoride in ng*h/mL
Observed Fluoride Baseline-Corrected AUC
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Area under the Curve for observed fluoride in ng*h/mL
Fluoride t1/2
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Terminal elimination half-life in hours for fluoride
Observed Fluoride Total Urinary Recovery
Time frame: baseline to 24 hours
Total urinary recovery in milligrams observed

Results and safety

Results posted to the registry on 21 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anti-caries Varnish	16	16

Primary outcome: Observed Iodine Tmax

Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Mean (Standard Deviation). Unit: hours

Measure	Anti-caries Varnish n = 16
Value	1.7 (0.7)

Primary outcome: Observed Iodine Cmax

Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Anti-caries Varnish n = 16
Value	111 (36)

Primary outcome: Observed Iodine Baseline-Corrected Cmax

Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Anti-caries Varnish n = 16
Value	57 (33)

Primary outcome: Observed Iodine Baseline-Corrected AUC

Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Mean (Standard Deviation). Unit: ng-h/mL

Measure	Anti-caries Varnish n = 16
Value	539 (315)

Adverse events

Time frame: 48 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anti-caries Varnish	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30938600Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of Iodine and Fluoride following Application of an Anticaries Varnish in Adults. JDR Clin Trans Res. 2018 Jul;3(3):238-245. doi: 10.1177/2380084418771930. Epub 2018 Apr 25.
Individual participant dataSharing planned: No

Related trials for Dental Caries

Active, not recruiting
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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.

Yvonne Lin, PhD principal investigator

University of Washington School of Pharmacy

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-caries varnish in people with Dental Caries, run by Advantage Silver Dental Arrest, LLC.

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 1 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2020). 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?

Observed Iodine Tmax (time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose). The study lists 13 primary outcomes in all. 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 NCT04183231, 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 21 Aug 2020.