Pharmacokinetics of Advantage Arrest
1 other identifier
interventional
16
1 country
1
Brief Summary
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2017
1 active site
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
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedFirst Submitted
Initial submission to the registry
November 28, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedResults Posted
Study results publicly available
August 14, 2020
CompletedJanuary 26, 2021
July 1, 2020
2 months
November 28, 2019
July 7, 2020
January 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
38% silver diamine fluoride
EXPERIMENTAL38% silver diamine fluoride, topical, 1 drop, single application
Interventions
Topical application of SDF to teeth
Eligibility Criteria
You may qualify if:
- years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications
You may not qualify if:
- pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advantage Silver Dental Arrest, LLClead
- University of Washingtoncollaborator
Study Sites (1)
University of Washington Institute of Translational Health Sciences
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 30803490RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Milgrom
- Organization
- Advantage Silver Dental Arrest, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Milgrom, DDS
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2019
First Posted
December 3, 2019
Study Start
August 1, 2017
Primary Completion
September 30, 2017
Study Completion
March 31, 2019
Last Updated
January 26, 2021
Results First Posted
August 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share