Phase 2
N=16
Pharmacokinetics of Advantage Arrest
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT04184271 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Observed Fluoride Urinary Recovery — 1.29 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 38% silver diamine fluoride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advantage Silver Dental Arrest, LLC
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Fluoride Urinary Recovery |
1.29 | — |
| PRIMARY Observed Silver Tmax |
5.3 | — |
| PRIMARY Observed Silver Cmax |
0.70 | — |
| PRIMARY Observed Silver Baseline-Corrected Cmax |
0.67 | — |
| PRIMARY Observed Silver t1/2 |
46 | — |
| PRIMARY Observed Silver 24 Hour Urinary Concentration |
0.05 | — |
Summary
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
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
Data sourced from ClinicalTrials.gov (NCT04184271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.