Phase 2
Completed N=59
Pharmacokinetics of Advantage Arrest in Children
Source: ClinicalTrials.gov NCT04186663 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Predicted Peak Serum Silver Concentration (Cmax) — 17.8 ng/ml
Summary
The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Predicted Peak Serum Silver Concentration (Cmax) |
17.8 | — |
| PRIMARY Predicted Time to Peak Serum Silver Concentration (Tmax) |
5.1 | — |
| PRIMARY Silver Half-life |
5.9 | — |
| SECONDARY Apparent Oral Clearance of Silver (CL/F) |
498 | — |
| SECONDARY Apparent Volume of Distribution of Silver (V/F) |
2294 | — |
| SECONDARY Serum Silver Exposure (AUC) |
149 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy.
- At least one carious lesion.
Exclusion Criteria
- Oral mucositis
- Any ulcerative lesions
- Hypersensitivity to silver
- Hypersensitivity to fluoride.
- SDF treatment within 3 months.
Data sourced from ClinicalTrials.gov (NCT04186663). 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. Informational only — not medical advice.