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Pharmacokinetics of Advantage Anti-Caries Varnish

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anti-caries varnish
Sponsored by
Advantage Silver Dental Arrest, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring adults, povidone iodine, sodium fluoride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Anti-caries varnish

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Observed Iodine Tmax
    Time to maximum serum concentration of iodine in hours
    Observed Iodine Cmax
    Maximum serum concentration of iodine in ng/mL
    Observed Iodine Baseline-Corrected Cmax
    Maximum serum concentration of iodine in ng/mL
    Observed Iodine Baseline-Corrected AUC
    Area under the Curve for observed iodine in ng*h/mL
    Observed Iodine Total Urinary Recovery
    Total urinary recovery in milligrams observed
    Iodine t1/2
    Terminal elimination half-life of iodine in hours
    Observed Fluoride Tmax
    Time to maximum serum concentration in hours
    Observed Fluoride Cmax
    Maximum serum concentration of fluoride in ng/mL
    Observed Fluoride Baseline-Corrected Cmax
    Maximum serum concentration of iodine in ng/mL
    Observed Fluoride AUC
    Area under the Curve for observed fluoride in ng*h/mL
    Observed Fluoride Baseline-Corrected AUC
    Area under the Curve for observed fluoride in ng*h/mL
    Fluoride t1/2
    Terminal elimination half-life in hours for fluoride
    Observed Fluoride Total Urinary Recovery
    Total urinary recovery in milligrams observed

    Secondary Outcome Measures

    Full Information

    First Posted
    November 27, 2019
    Last Updated
    July 31, 2020
    Sponsor
    Advantage Silver Dental Arrest, LLC
    Collaborators
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04183231
    Brief Title
    Pharmacokinetics of Advantage Anti-Caries Varnish
    Official Title
    Pharmacokinetics of Advantage Anti-Caries Varnish
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    February 28, 2017 (Actual)
    Study Completion Date
    April 25, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Advantage Silver Dental Arrest, LLC
    Collaborators
    University of Washington

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    adults, povidone iodine, sodium fluoride

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open label exposure--response study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anti-caries varnish
    Arm Type
    Experimental
    Arm Description
    topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application
    Intervention Type
    Drug
    Intervention Name(s)
    Anti-caries varnish
    Intervention Description
    topical tooth varnish
    Primary Outcome Measure Information:
    Title
    Observed Iodine Tmax
    Description
    Time to maximum serum concentration of iodine in hours
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Iodine Cmax
    Description
    Maximum serum concentration of iodine in ng/mL
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Iodine Baseline-Corrected Cmax
    Description
    Maximum serum concentration of iodine in ng/mL
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Iodine Baseline-Corrected AUC
    Description
    Area under the Curve for observed iodine in ng*h/mL
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Iodine Total Urinary Recovery
    Description
    Total urinary recovery in milligrams observed
    Time Frame
    baseline to 24 hours
    Title
    Iodine t1/2
    Description
    Terminal elimination half-life of iodine in hours
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Fluoride Tmax
    Description
    Time to maximum serum concentration in hours
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Fluoride Cmax
    Description
    Maximum serum concentration of fluoride in ng/mL
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Fluoride Baseline-Corrected Cmax
    Description
    Maximum serum concentration of iodine in ng/mL
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Fluoride AUC
    Description
    Area under the Curve for observed fluoride in ng*h/mL
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Fluoride Baseline-Corrected AUC
    Description
    Area under the Curve for observed fluoride in ng*h/mL
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Fluoride t1/2
    Description
    Terminal elimination half-life in hours for fluoride
    Time Frame
    0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
    Title
    Observed Fluoride Total Urinary Recovery
    Description
    Total urinary recovery in milligrams observed
    Time Frame
    baseline to 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications. Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yvonne Lin, PhD
    Organizational Affiliation
    University of Washington School of Pharmacy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30938600
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Pharmacokinetics of Advantage Anti-Caries Varnish

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