Dental CariesPhase 2NCT04184271
Pharmacokinetics of Advantage Arrest
A Phase 2 study testing 38% silver diamine fluoride in people with Dental Caries, run by Advantage Silver Dental Arrest, LLC at 1 site in United States.
Trial summary
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- 38% silver diamine fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications
Who cannot join
- pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Institute of Translational Health Sciences
Seattle, Washington, 98195
About this study
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
Read the 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).
- Conditions
- Dental Caries
- Being tested
- 38% silver diamine fluoride
- Keywords
- adult, fluoride, silver, silver diamine fluoride, pharmacokinetics
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38% silver diamine fluorideDrug
Also called Advantage Arrest
Topical application of SDF to teeth
| Study group | Role | What they receive |
|---|---|---|
| 38% silver diamine fluoride | Experimental | 38% silver diamine fluoride, topical, 1 drop, single application Receives: Drug: 38% silver diamine fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Fluoride Urinary Recovery
24 hour fluoride urinary recovery (in mg)
Measured: baseline to 24 hours
Observed Silver Tmax
Observed silver time to maximum serum concentration in hours
Measured: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed Silver Cmax
Observed silver maximum serum concentration in ng/mL
Measured: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed Silver Baseline-Corrected Cmax
Observed silver baseline-corrected maximum serum concentration in ng/mL
Measured: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed Silver t1/2
Observed silver serum elimination half-life in hours
Measured: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Observed Silver 24 Hour Urinary Concentration
Observed silver 24-hour urinary concentration in ng/mL
Measured: baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Aug 2017
- Primary completion30 Sep 2017
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label exposure--response study
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advantage Silver Dental Arrest, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Peter Milgrom, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184271
- Sponsor's protocol ID
- 2016-11-08
- Status last verified
- Jul 2020
- First submitted
- 28 Nov 2019
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. J Am Dent Assoc. 2019 Mar;150(3):186-192. doi: 10.1016/j.adaj.2018.10.018.
PubMed 30803490
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Advantage Arrest
- ClinicalTrials.gov ID
- NCT04184271
- Acronym / sponsor ID
- 2016-11-08
- Conditions
- Dental Caries
- Keywords
- adult, fluoride, silver, silver diamine fluoride, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Advantage Silver Dental Arrest, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Posted 14 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label exposure--response study
| Arm | Type | Receives |
|---|---|---|
| 38% silver diamine fluoride | Experimental | Drug: 38% silver diamine fluoride38% silver diamine fluoride, topical, 1 drop, single application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications
Key exclusion criteria (1 listed)
- pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 38% silver diamine fluorideAlso: Advantage ArrestTopical application of SDF to teeth | Drug | 38% silver diamine fluoride |
Primary outcome
Observed Fluoride Urinary Recovery
Time frame: baseline to 24 hours
24 hour fluoride urinary recovery (in mg)
Observed Silver Tmax
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to 24 hours
Observed silver 24-hour urinary concentration in ng/mL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30803490Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. J Am Dent Assoc. 2019 Mar;150(3):186-192. doi: 10.1016/j.adaj.2018.10.018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Milgrom, DDS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 38% silver diamine fluoride in people with Dental Caries, run by Advantage Silver Dental Arrest, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Fluoride Urinary Recovery (time frame: baseline to 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.