Dental Caries
Conditions
Keywords
adult, fluoride, silver, silver diamine fluoride, pharmacokinetics
Brief summary
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
Detailed description
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).
Interventions
Topical application of SDF to teeth
Sponsors
University of Washington
Advantage Silver Dental Arrest, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label exposure--response study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Fluoride Urinary Recovery | baseline to 24 hours | 24 hour fluoride urinary recovery (in mg) |
| Observed Silver Tmax | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | Observed silver time to maximum serum concentration in hours |
| Observed Silver Cmax | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | Observed silver maximum serum concentration in ng/mL |
| Observed Silver Baseline-Corrected Cmax | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | Observed silver baseline-corrected maximum serum concentration in ng/mL |
| Observed Silver t1/2 | baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours | Observed silver serum elimination half-life in hours |
| Observed Silver 24 Hour Urinary Concentration | baseline to 24 hours | Observed silver 24-hour urinary concentration in ng/mL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 38% Silver Diamine Fluoride 38% silver diamine fluoride, topical, 1 drop, single application
38% silver diamine fluoride: Topical application of SDF to teeth | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | 38% Silver Diamine Fluoride |
|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 13.4 |
| Baseline Fluoride | 26 ng/mL STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
| Silver Observed Baseline | 0.15 ng/mL STANDARD_DEVIATION 0.03 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Observed Fluoride Urinary Recovery
24 hour fluoride urinary recovery (in mg)
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 38% Silver Diamine Fluoride | Observed Fluoride Urinary Recovery | 1.29 mg | Standard Deviation 0.81 |
Primary
Observed Silver 24 Hour Urinary Concentration
Observed silver 24-hour urinary concentration in ng/mL
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 38% Silver Diamine Fluoride | Observed Silver 24 Hour Urinary Concentration | 0.05 ng/mL |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 38% Silver Diamine Fluoride | Observed Silver Baseline-Corrected Cmax | 0.67 ng/mL | Standard Deviation 0.49 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 38% Silver Diamine Fluoride | Observed Silver Cmax | 0.70 ng/mL | Standard Deviation 0.52 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 38% Silver Diamine Fluoride | Observed Silver t1/2 | 46 hours | Standard Deviation 26 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 38% Silver Diamine Fluoride | Observed Silver Tmax | 5.3 hours | Standard Deviation 5.8 |