Observed Iodine Tmax
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to maximum serum concentration of iodine in hours
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 1.7 | ± 0.7 |
Last reviewed · How we verify
NCT04183231
Pharmacokinetics of Advantage Anti-Caries Varnish
Completed
Phase 2
Results posted
Last updated 21 August 2020
What this trial tests
Phase 2 trial testing Anti-caries varnish in Dental Caries in 16 participants. Completed in 25 April 2018.
Timeline
1 November 2016
Primary endpoint
28 February 2017
28 February 2017
25 April 2018
Quick facts
| Lead sponsor | Advantage Silver Dental Arrest, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 November 2016 |
| Primary completion | 28 February 2017 |
| Estimated completion | 25 April 2018 |
Drugs / interventions tested
- Anti-caries varnish — full drug profile →
Conditions studied
- Dental Caries — all drugs for Dental Caries →
Sponsor
Advantage Silver Dental Arrest, LLC — full company profile →
Who can join
18 and older, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Observed Iodine Cmax
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 111 | ± 36 |
Observed Iodine Baseline-Corrected Cmax
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 57 | ± 33 |
Observed Iodine Baseline-Corrected AUC
Primary
· 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
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 539 | ± 315 |
Observed Iodine Total Urinary Recovery
Primary
· baseline to 24 hours
Total urinary recovery in milligrams observed
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 1.26 | ± 0.71 |
Iodine t1/2
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Terminal elimination half-life of iodine in hours
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 5.5 | ± 1.4 |
Observed Fluoride Tmax
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to maximum serum concentration in hours
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 0.8 | ± 0.3 |
Observed Fluoride Cmax
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of fluoride in ng/mL
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 76 | ± 36 |
Observed Fluoride Baseline-Corrected Cmax
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Maximum serum concentration of iodine in ng/mL
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 60 | ± 34 |
Observed Fluoride AUC
Primary
· 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
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 703 | ± 350 |
Observed Fluoride Baseline-Corrected AUC
Primary
· 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
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 315 | ± 206 |
Fluoride t1/2
Primary
· 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Terminal elimination half-life in hours for fluoride
| Group | Value | 95% CI |
|---|---|---|
| Anti-caries Varnish | 3.1 | ± 1.6 |
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04183231
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Advantage Silver Dental Arrest, LLC trials
Trials by the same sponsor.
- NCT05670743 — Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age · Phase 2 · completed
- NCT05395065 — Silver Diamine Fluoride Gel: Case Series · completed
- NCT04947527 — Efficacy and Safety Evaluation of Anti-Caries Varnish · Phase 2 · completed
- NCT04186663 — Pharmacokinetics of Advantage Arrest in Children · Phase 2 · completed
- NCT04184271 — Pharmacokinetics of Advantage Arrest · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04183231 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Advantage Silver Dental Arrest, LLC
- Last refreshed: 21 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04183231.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing