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| Name | Class |
|---|---|
| University of Washington | OTHER |
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The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 38% silver diamine fluoride | Experimental | 38% silver diamine fluoride, topical, 1 drop, single application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 38% silver diamine fluoride | Drug | Topical application of SDF to teeth |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed Fluoride Urinary Recovery | 24 hour fluoride urinary recovery (in mg) | baseline to 24 hours |
| Observed Silver Tmax | Observed silver time to maximum serum concentration in hours | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
| Observed Silver Cmax | Observed silver maximum serum concentration in ng/mL | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
| Observed Silver Baseline-Corrected Cmax | Observed silver baseline-corrected maximum serum concentration in ng/mL | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
| Observed Silver t1/2 | Observed silver serum elimination half-life in hours | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
| Observed Silver 24 Hour Urinary Concentration | Observed silver 24-hour urinary concentration in ng/mL | baseline to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Milgrom, DDS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Institute of Translational Health Sciences | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30803490 | Result | Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. J Am Dent Assoc. 2019 Mar;150(3):186-192. doi: 10.1016/j.adaj.2018.10.018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 38% Silver Diamine Fluoride | 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 38% Silver Diamine Fluoride | 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth |
| 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, Continuous | Mean |
| 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 Fluoride Urinary Recovery | 24 hour fluoride urinary recovery (in mg) | Posted | Mean | Standard Deviation | mg | baseline to 24 hours |
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|
24 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 | 38% Silver Diamine Fluoride | 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Milgrom | Advantage Silver Dental Arrest, LLC | 2062516831 | drmilgrom@silverarrest.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2020 | Jul 31, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 8, 2016 | Jul 31, 2020 | Prot_002.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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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
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Open label exposure--response study
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| 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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| Silver Observed Baseline | Mean | Standard Deviation | ng/mL |
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| Baseline Fluoride | Mean | Standard Deviation | ng/mL |
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| Primary | Observed Silver Tmax | Observed silver time to maximum serum concentration in hours | Posted | Mean | Standard Deviation | hours | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
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| Primary | Observed Silver Cmax | Observed silver maximum serum concentration in ng/mL | Posted | Mean | Standard Deviation | ng/mL | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
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| Primary | Observed Silver Baseline-Corrected Cmax | Observed silver baseline-corrected maximum serum concentration in ng/mL | Posted | Mean | Standard Deviation | ng/mL | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
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| Primary | Observed Silver t1/2 | Observed silver serum elimination half-life in hours | Posted | Mean | Standard Deviation | hours | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours |
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| Primary | Observed Silver 24 Hour Urinary Concentration | Observed silver 24-hour urinary concentration in ng/mL | Posted | Mean | Full Range | ng/mL | baseline to 24 hours |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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