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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Topical application of SDF to teeth
University of Washington Institute of Translational Health Sciences
Seattle, Washington, United States
Observed Fluoride Urinary Recovery
24 hour fluoride urinary recovery (in mg)
Time frame: baseline to 24 hours
Observed Silver Tmax
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
Observed Silver Cmax
Observed silver maximum serum concentration in ng/mL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to 24 hours
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