NCT04183231

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

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

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 21, 2020

Completed
Last Updated

August 21, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

November 27, 2019

Results QC Date

July 10, 2020

Last Update Submit

July 31, 2020

Conditions

Dental Caries

Keywords

adultspovidone iodinesodium fluoride

Outcome Measures

Primary Outcomes (13)

  • Observed Iodine Tmax

    Time to maximum serum concentration of iodine in hours

    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

    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

    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

    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

    baseline to 24 hours

  • Iodine t1/2

    Terminal elimination half-life of iodine in hours

    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

    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

    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

    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

    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

    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

    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

    baseline to 24 hours

Study Arms (1)

Anti-caries varnish

EXPERIMENTAL

topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application

Drug: Anti-caries varnish

Interventions

Anti-caries varnishDRUG

topical tooth varnish

Anti-caries varnish

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30938600RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr. Peter Milgrom
Organization
Advantage Silver Dental Arrest, LLC
drmilgrom@silverarrest.com
206-2516831

Study Officials

  • Yvonne Lin, PhD

    University of Washington School of Pharmacy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label exposure--response study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 3, 2019

Study Start

November 1, 2016

Primary Completion

February 28, 2017

Study Completion

April 25, 2018

Last Updated

August 21, 2020

Results First Posted

August 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share