Back to resultsPharmacokinetics of Advantage Arrest
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
38% silver diamine fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring adult, fluoride, silver, silver diamine fluoride, pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications
Exclusion Criteria:
- pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Sites / Locations
- University of Washington Institute of Translational Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
38% silver diamine fluoride
Arm Description
38% silver diamine fluoride, topical, 1 drop, single application
Outcomes
Primary Outcome Measures
Observed Fluoride Urinary Recovery
24 hour fluoride urinary recovery (in mg)
Observed Silver Tmax
Observed silver time to maximum serum concentration in hours
Observed Silver Cmax
Observed silver maximum serum concentration in ng/mL
Observed Silver Baseline-Corrected Cmax
Observed silver baseline-corrected maximum serum concentration in ng/mL
Observed Silver t1/2
Observed silver serum elimination half-life in hours
Observed Silver 24 Hour Urinary Concentration
Observed silver 24-hour urinary concentration in ng/mL
Secondary Outcome Measures
Full Information
NCT ID
NCT04184271
First Posted
November 28, 2019
Last Updated
January 11, 2021
Sponsor
Advantage Silver Dental Arrest, LLC
Collaborators
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT04184271
Brief Title
Pharmacokinetics of Advantage Arrest
Official Title
Pharmacokinetics of Advantage Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
March 31, 2019 (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
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
adult, fluoride, silver, silver diamine fluoride, pharmacokinetics
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
38% silver diamine fluoride
Arm Type
Experimental
Arm Description
38% silver diamine fluoride, topical, 1 drop, single application
Intervention Type
Drug
Intervention Name(s)
38% silver diamine fluoride
Other Intervention Name(s)
Advantage Arrest
Intervention Description
Topical application of SDF to teeth
Primary Outcome Measure Information:
Title
Observed Fluoride Urinary Recovery
Description
24 hour fluoride urinary recovery (in mg)
Time Frame
baseline to 24 hours
Title
Observed Silver Tmax
Description
Observed silver time to maximum serum concentration in hours
Time Frame
baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Title
Observed Silver Cmax
Description
Observed silver maximum serum concentration in ng/mL
Time Frame
baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Title
Observed Silver Baseline-Corrected Cmax
Description
Observed silver baseline-corrected maximum serum concentration in ng/mL
Time Frame
baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Title
Observed Silver t1/2
Description
Observed silver serum elimination half-life in hours
Time Frame
baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Title
Observed Silver 24 Hour Urinary Concentration
Description
Observed silver 24-hour urinary concentration in ng/mL
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:
18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications
Exclusion Criteria:
pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Milgrom, DDS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Institute of Translational Health Sciences
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30803490
Citation
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.
Results Reference
result
Learn more about this trial
Pharmacokinetics of Advantage Arrest
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