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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-caries varnish | Experimental | topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-caries varnish | Drug | topical tooth varnish |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Lin, PhD | University of Washington School of Pharmacy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30938600 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-caries Varnish | topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-caries Varnish | topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observed Iodine Tmax | Time to maximum serum concentration of iodine in hours | Posted | Mean | Standard Deviation | hours | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anti-caries Varnish | topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application Anti-caries varnish: topical tooth varnish |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Milgrom | Advantage Silver Dental Arrest, LLC | 206-2516831 | drmilgrom@silverarrest.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2020 | Jul 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Open label exposure--response study
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| 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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Observed Iodine Cmax | Maximum serum concentration of iodine in ng/mL | Posted | Mean | Standard Deviation | ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Iodine Baseline-Corrected Cmax | Maximum serum concentration of iodine in ng/mL | Posted | Mean | Standard Deviation | ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Iodine Baseline-Corrected AUC | Area under the Curve for observed iodine in ng*h/mL | Posted | Mean | Standard Deviation | ng-h/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Iodine Total Urinary Recovery | Total urinary recovery in milligrams observed | Posted | Mean | Standard Deviation | mg | baseline to 24 hours |
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| Primary | Iodine t1/2 | Terminal elimination half-life of iodine in hours | Posted | Mean | Standard Deviation | hours | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Fluoride Tmax | Time to maximum serum concentration in hours | Posted | Mean | Standard Deviation | hours | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Fluoride Cmax | Maximum serum concentration of fluoride in ng/mL | Posted | Mean | Standard Deviation | ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Fluoride Baseline-Corrected Cmax | Maximum serum concentration of iodine in ng/mL | Posted | Mean | Standard Deviation | ng/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Fluoride AUC | Area under the Curve for observed fluoride in ng*h/mL | Posted | Mean | Standard Deviation | ng-h/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Fluoride Baseline-Corrected AUC | Area under the Curve for observed fluoride in ng*h/mL | Posted | Mean | Standard Deviation | ng-h/mL | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Fluoride t1/2 | Terminal elimination half-life in hours for fluoride | Posted | Mean | Standard Deviation | hours | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
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| Primary | Observed Fluoride Total Urinary Recovery | Total urinary recovery in milligrams observed | Posted | Mean | Standard Deviation | mg | baseline to 24 hours |
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| 0 |
| 16 |
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| 16 |
| 0 |
| 16 |
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