Dental Caries
Conditions
Keywords
adults, povidone iodine, sodium fluoride
Brief summary
The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.
Detailed description
The study was to characterize serum iodine and fluoride levels over 24 hours after application of a topical dental varnish in healthy adults 23 to 57 years old.
Interventions
DRUGAnti-caries varnish
topical tooth varnish
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
* Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.
Exclusion criteria
* Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions, sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism, hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular thread with heart disease, multi nodular goiter, Graves disease, or autoimmune thyroiditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Iodine Tmax | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Time to maximum serum concentration of iodine in hours |
| Observed Iodine Cmax | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Maximum serum concentration of iodine in ng/mL |
| Observed Iodine Baseline-Corrected Cmax | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Maximum serum concentration of iodine in ng/mL |
| Observed Iodine Baseline-Corrected AUC | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Area under the Curve for observed iodine in ng\*h/mL |
| Observed Iodine Total Urinary Recovery | baseline to 24 hours | Total urinary recovery in milligrams observed |
| Iodine t1/2 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Terminal elimination half-life of iodine in hours |
| Observed Fluoride Tmax | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Time to maximum serum concentration in hours |
| Observed Fluoride Cmax | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Maximum serum concentration of fluoride in ng/mL |
| Observed Fluoride Baseline-Corrected Cmax | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Maximum serum concentration of iodine in ng/mL |
| Observed Fluoride AUC | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Area under the Curve for observed fluoride in ng\*h/mL |
| Observed Fluoride Baseline-Corrected AUC | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Area under the Curve for observed fluoride in ng\*h/mL |
| Fluoride t1/2 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose | Terminal elimination half-life in hours for fluoride |
| Observed Fluoride Total Urinary Recovery | baseline to 24 hours | Total urinary recovery in milligrams observed |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anti-caries Varnish topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application
Anti-caries varnish: topical tooth varnish | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Anti-caries Varnish |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 41.4 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 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 |
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
Fluoride t1/2
Terminal elimination half-life in hours for fluoride
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Fluoride t1/2 | 3.1 hours | Standard Deviation 1.6 |
Primary
Iodine t1/2
Terminal elimination half-life of iodine in hours
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Iodine t1/2 | 5.5 hours | Standard Deviation 1.4 |
Primary
Observed Fluoride AUC
Area under the Curve for observed fluoride in ng\*h/mL
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Fluoride AUC | 703 ng-h/mL | Standard Deviation 350 |
Primary
Observed Fluoride Baseline-Corrected AUC
Area under the Curve for observed fluoride in ng\*h/mL
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Fluoride Baseline-Corrected AUC | 315 ng-h/mL | Standard Deviation 206 |
Primary
Observed Fluoride Baseline-Corrected Cmax
Maximum serum concentration of iodine in ng/mL
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Fluoride Baseline-Corrected Cmax | 60 ng/mL | Standard Deviation 34 |
Primary
Observed Fluoride Cmax
Maximum serum concentration of fluoride in ng/mL
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Fluoride Cmax | 76 ng/mL | Standard Deviation 36 |
Primary
Observed Fluoride Tmax
Time to maximum serum concentration in hours
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Fluoride Tmax | 0.8 hours | Standard Deviation 0.3 |
Primary
Observed Fluoride Total Urinary Recovery
Total urinary recovery in milligrams observed
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Fluoride Total Urinary Recovery | 2.51 mg | Standard Deviation 1.28 |
Primary
Observed Iodine Baseline-Corrected AUC
Area under the Curve for observed iodine in ng\*h/mL
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Iodine Baseline-Corrected AUC | 539 ng-h/mL | Standard Deviation 315 |
Primary
Observed Iodine Baseline-Corrected Cmax
Maximum serum concentration of iodine in ng/mL
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Iodine Baseline-Corrected Cmax | 57 ng/mL | Standard Deviation 33 |
Primary
Observed Iodine Cmax
Maximum serum concentration of iodine in ng/mL
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Iodine Cmax | 111 ng/mL | Standard Deviation 36 |
Primary
Observed Iodine Tmax
Time to maximum serum concentration of iodine in hours
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Iodine Tmax | 1.7 hours | Standard Deviation 0.7 |
Primary
Observed Iodine Total Urinary Recovery
Total urinary recovery in milligrams observed
Time frame: baseline to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-caries Varnish | Observed Iodine Total Urinary Recovery | 1.26 mg | Standard Deviation 0.71 |