Trial Outcomes & Findings for Pharmacokinetics of Advantage Arrest (NCT NCT04184271)

NCT ID: NCT04184271

Last Updated: 2021-01-26

Results Overview

24 hour fluoride urinary recovery (in mg)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: baseline to 24 hours
• Results posted on: 2021-01-26

Participant Flow

Participant milestones

Measure	38% Silver Diamine Fluoride 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Advantage Arrest

Baseline characteristics by cohort

Measure	38% Silver Diamine Fluoride n=16 Participants 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Age, Continuous	41.4 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Silver Observed Baseline	0.15 ng/mL STANDARD_DEVIATION 0.03 • n=5 Participants
Baseline Fluoride	26 ng/mL STANDARD_DEVIATION 12 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to 24 hours

24 hour fluoride urinary recovery (in mg)

Outcome measures

Measure	38% Silver Diamine Fluoride n=16 Participants 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Observed Fluoride Urinary Recovery	1.29 mg Standard Deviation 0.81

PRIMARY outcome

Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Observed silver time to maximum serum concentration in hours

Outcome measures

Measure	38% Silver Diamine Fluoride n=16 Participants 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Observed Silver Tmax	5.3 hours Standard Deviation 5.8

PRIMARY outcome

Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Observed silver maximum serum concentration in ng/mL

Outcome measures

Measure	38% Silver Diamine Fluoride n=16 Participants 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Observed Silver Cmax	0.70 ng/mL Standard Deviation 0.52

PRIMARY outcome

Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Observed silver baseline-corrected maximum serum concentration in ng/mL

Outcome measures

Measure	38% Silver Diamine Fluoride n=16 Participants 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Observed Silver Baseline-Corrected Cmax	0.67 ng/mL Standard Deviation 0.49

PRIMARY outcome

Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Observed silver serum elimination half-life in hours

Outcome measures

Measure	38% Silver Diamine Fluoride n=16 Participants 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Observed Silver t1/2	46 hours Standard Deviation 26

PRIMARY outcome

Timeframe: baseline to 24 hours

Observed silver 24-hour urinary concentration in ng/mL

Outcome measures

Measure	38% Silver Diamine Fluoride n=16 Participants 38% silver diamine fluoride, topical, 1 drop, single application 38% silver diamine fluoride: Topical application of SDF to teeth
Observed Silver 24 Hour Urinary Concentration	0.05 ng/mL Interval 0.05 to 0.06

Adverse Events

38% Silver Diamine Fluoride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Milgrom

Advantage Silver Dental Arrest, LLC

Phone: 2062516831

Email: drmilgrom@silverarrest.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place