Dental Caries
Conditions
Brief summary
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.
Interventions
DRUGVarnish
Topical application to the teeth
Sponsors
Advantage Dental Services, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
36 Months to 60 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy
Exclusion criteria
* Weight less than 15 kg or hypersensitivity to iodine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft Tissue | within 48 hours | Proportion of participants with any oral ulcerations OR inflammatory response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | within 48 hours | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varnish Dental varnish containing povidone iodine and sodium fluoride
Varnish: Topical application to the teeth | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Varnish |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Soft Tissue
Proportion of participants with any oral ulcerations OR inflammatory response
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varnish | Soft Tissue | 0 Participants |
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
Time frame: within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varnish | Adverse Events | 0 Participants |