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The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varnish | Experimental | Dental varnish containing povidone iodine and sodium fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varnish | Drug | Topical application to the teeth |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Soft Tissue | Proportion of participants with any oral ulcerations OR inflammatory response | within 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Milgrom, DDS | Advantage Dental | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Regional Clinical Dental Research Center | Seattle | Washington | 98112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varnish | Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varnish | Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Soft Tissue | Proportion of participants with any oral ulcerations OR inflammatory response | Posted | Count of Participants | Participants | within 48 hours |
|
|
48 hours
Intraoral erythema
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varnish | Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Milgrom | Advantage Silver Dental Arrest, LLC | 2062516831 | drmilgrom@silverarrest.com |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D010150 | Paint |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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 | Posted | Count of Participants | Participants | within 48 hours |
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| 0 |
| 12 |
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| 12 |
| 0 |
| 12 |
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