Dental Caries in ChildrenPhase 2NCT05670743
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
A Phase 2 study testing 38% silver diamine fluoride in people with Dental Caries in Children, run by Advantage Silver Dental Arrest, LLC at 1 site in United States.
Trial summary
The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards. Read more about this study
- Who is it for?
- Ages 13 months to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- 38% silver diamine fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 13 months to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one untreated caries lesion into the dentin
- Live within 10 miles of study site
Who cannot join
- oral mucositis
- ulcerative oral lesions
- hypersensitivity to silver or fluoride
- history of treatment with silver diamine fluoride within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Pediatric Dentistry
Seattle, Washington, 98195
About this study
The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards.
Read the detailed description
The FDA requested additional data to evaluate the pharmacokinetics of silver diamine fluoride (SDF, Advantage Arrest) in children 13 months to 13 years old. The first request is for children under 36 months of age to be included in a study. The second request is for serum silver concentration be evaluated for a longer duration post-application to better estimate the half-life of silver and return of serum silver to baseline levels in children.
- Conditions
- Dental Caries in Children
- Being tested
- 38% silver diamine fluoride
- Keywords
- pharmacokinetics
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 Silver Arrest
Topical application of 38% silver diamine fluoride to dental caries lesions
| Study group | Role | What they receive |
|---|---|---|
| Silver diamine fluoride | Experimental | Silver diamine fluoride, 38%, topical, 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.
Fluoride Cmax
Maximum serum concentration of fluoride
Measured: 21 days
Silver Cmax
Maximum serum concentration of silver
Measured: 21 days
Fluoride Tmax
Time to maximum serum concentration of fluoride
Measured: 21 days
Silver Tmax
Time to maximum serum concentration of silver
Measured: 21 days
Area Under Curve, Fluoride
Area under the curve, fluoride
Measured: 21 days
Area Under Curve, Silver
Area under the curve, silver
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Mar 2023
- Primary completion10 Jun 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest.
- Masking
- None (open label)
- Enrolment
- 23 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
- Travis Nelson, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670743
- Sponsor's protocol ID
- SDF PK WCGIRB-v1
- Status last verified
- Aug 2024
- First submitted
- 2 Jan 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
- ClinicalTrials.gov ID
- NCT05670743
- Acronym / sponsor ID
- SDF PK WCGIRB-v1
- Conditions
- Dental Caries in Children
- Keywords
- pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Advantage Silver Dental Arrest, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards.
Detailed description
The FDA requested additional data to evaluate the pharmacokinetics of silver diamine fluoride (SDF, Advantage Arrest) in children 13 months to 13 years old. The first request is for children under 36 months of age to be included in a study. The second request is for serum silver concentration be evaluated for a longer duration post-application to better estimate the half-life of silver and return of serum silver to baseline levels in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest.
| Arm | Type | Receives |
|---|---|---|
| Silver diamine fluoride | Experimental | Drug: 38% silver diamine fluorideSilver diamine fluoride, 38%, topical, single application |
Who may qualify
- Ages
- 13 months to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- At least one untreated caries lesion into the dentin
- Live within 10 miles of study site
Key exclusion criteria (4 listed)
- oral mucositis
- ulcerative oral lesions
- hypersensitivity to silver or fluoride
- history of treatment with silver diamine fluoride within 3 months
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 Silver ArrestTopical application of 38% silver diamine fluoride to dental caries lesions | Drug | Silver diamine fluoride |
Primary outcome
Fluoride Cmax
Time frame: 21 days
Maximum serum concentration of fluoride
Silver Cmax
Time frame: 21 days
Maximum serum concentration of silver
Fluoride Tmax
Time frame: 21 days
Time to maximum serum concentration of fluoride
Silver Tmax
Time frame: 21 days
Time to maximum serum concentration of silver
Area Under Curve, Fluoride
Time frame: 21 days
Area under the curve, fluoride
Area Under Curve, Silver
Time frame: 21 days
Area under the curve, silver
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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.
Travis Nelson, 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 in Children, 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 2 inclusion and 4 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 6 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fluoride Cmax (time frame: 21 days). 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?
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 6 Aug 2024.