Dental CariesPhase 1NCT02645617
Safety Evaluation of Advantage Anti-Caries Varnish
A Phase 1 study testing Varnish in people with Dental Caries, run by Advantage Dental Services, LLC at 1 site in United States.
Trial summary
The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish. Read more about this study
- Who is it for?
- Ages 36 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2016to 20 Oct 2016
- Phase
- Phase 1
- 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 36 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
Who cannot join
- Weight less than 15 kg or hypersensitivity to iodine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Regional Clinical Dental Research Center
Seattle, Washington, 98112
About this study
Official title: Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
Read the detailed description
This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride [Therametrics Technologies, Inc, Noblesville, IN, USA]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.
- Conditions
- Dental Caries
- Being tested
- Varnish
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VarnishDrug
Also called Advantage Anti-Caries Varnish
Topical application to the teeth
| Study group | Role | What they receive |
|---|---|---|
| Varnish | Experimental | Dental varnish containing povidone iodine and sodium fluoride Receives: Drug: Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue
Proportion of participants with any oral ulcerations OR inflammatory response
Measured: within 48 hours
Secondary outcomes (1)
Adverse Events
Proportion of participants with any emergency medical care OR report of nausea OR not eating OR vomiting OR difficulty swallowing OR swelling around the mouth OR itchiness around the mouth OR hives OR rash OR stomach ache OR diarrhea
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study start30 Mar 2016
- Primary completion30 Sep 2016
- Study completion20 Oct 2016
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advantage Dental Services, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Milgrom, DDS, Principal investigator, Advantage Dental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645617
- Sponsor's protocol ID
- PVP-I Varnish
- Status last verified
- Jan 2020
- First submitted
- 28 Dec 2015
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
- ClinicalTrials.gov ID
- NCT02645617
- Acronym / sponsor ID
- PVP-I Varnish
- Conditions
- Dental Caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Advantage Dental Services, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Posted 21 Jan 2020
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 the study is to confirm the safety of Advantage Anti-Caries Varnish.
Detailed description
This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride [Therametrics Technologies, Inc, Noblesville, IN, USA]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varnish | Experimental | Drug: VarnishDental varnish containing povidone iodine and sodium fluoride |
Who may qualify
- Ages
- 36 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Weight less than 15 kg or hypersensitivity to iodine
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 |
|---|---|---|
| VarnishAlso: Advantage Anti-Caries VarnishTopical application to the teeth | Drug | Varnish |
Primary outcome
Soft Tissue
Time frame: within 48 hours
Proportion of participants with any oral ulcerations OR inflammatory response
1 secondary outcome
Adverse Events
Time frame: within 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Advantage Dental
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varnish in people with Dental Caries, run by Advantage Dental Services, 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 21 Jan 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 21 Jan 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?
Soft Tissue (time frame: within 48 hours). 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 21 Jan 2020.