Dental Caries in Children
Conditions
Keywords
sodium fluoride, povidone iodine, dental varnish, primary dentition
Brief summary
The purpose of the study is to determine the efficacy & safety of Advantage Anti-Caries Varnish for primary prevention. The objectives are: 1\) To determine if Advantage Anti-Caries Varnish (test varnish) is superior to an active control varnish (5% Sodium Fluoride, no Povidone-Iodine) in the prevention of caries lesions in the primary dentition. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) To document the safety of the test varnish.
Detailed description
This is a single center randomized, double-blind, placebo-controlled, parallel-group trial. The treatment group will be exposed at baseline and once every three to four months after baseline for a maximum period of 24 months. The control group will be exposed to the control varnish in the same manner. 254 subjects will be enrolled. Half will be randomized to each arm. Subjects will be 6-24 mo of age and in good health. Children attending Maternal and Child Health (MCH) Immunization and Well Child programs in Pohnpei State will be enrolled. Primary Outcome Variables: 1) Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline; 2) Presence/Absence of dental caries lesions (d2-4mfs \>0) at 12 months post baseline. Secondary Outcome Variable: Adverse Events
Interventions
DRUGTest varnish
A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
DRUGPlacebo
A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
Sponsors
Advantage Silver Dental Arrest, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All study personnel except for designated personnel in the data center will be blinded to the participant treatment assignment. In order to maintain blinding and eliminate examiner bias, the staff member applying these varnishes will not perform the caries scoring exams.
Intervention model description
This is a single center randomized, double-blind, placebo-controlled, parallel-group trial.
Eligibility
Sex/Gender
ALL
Age
10 Months to 20 Months
Healthy volunteers
Yes
Inclusion criteria
1. The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form). 2. The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements. 3. The subject is a 6-24 months at the time of enrollment. 4. The subject must be in good general health as evidenced by parent report. 5. The subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion.
Exclusion criteria
1. Previous treatment with fluoride varnish 2. Known allergy to iodine 3. Diagnosis of thyroid disease 4. Chronic, prophylactic use of antibiotics 5. Treatment with another investigational drug or intervention within 30 days preceding the Baseline Visit. 6. Visible cavities (d2-4) 7. Presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared) 8. Parent anticipates the child will move from Pohnpei during the next 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caries Increment | 24 months post baseline | Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline, which is the number of surfaces at 24 months post baseline with cavitation into the enamel (d2), dentin (d3) or pulp (d4), missing due to caries (m) or filled (f). |
| Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces | 12 months post baseline | Presence/Absence of dental caries lesions (d2-4mfs \>0), which is defined by the presence at 12 months post baseline of 1 or more tooth surfaces with cavitation into the enamel (d2), into the dentin (d3), or into the pulp (d4), missing due to caries (m) or filled (f). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 24 months post baseline | Cumulative Adverse and Serious Adverse Events |
Countries
United States Minor Outlying Islands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Varnish Anti-Caries Varnish. The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS.
Test varnish: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals. | 132 |
| Control Varnish Control Varnish. 5% (w/v) Sodium Fluoride .
Placebo: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals. | 142 |
| Total | 274 |
Baseline characteristics
| Characteristic | Control Varnish | Total | Test Varnish |
|---|---|---|---|
| Age, Continuous | 14.3 Months STANDARD_DEVIATION 4.5 | 14.1 Months STANDARD_DEVIATION 4.4 | 13.9 Months STANDARD_DEVIATION 4.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 142 Participants | 274 Participants | 132 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 83 Participants | 149 Participants | 66 Participants |
| Sex: Female, Male Male | 59 Participants | 125 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 142 |
| other Total, other adverse events | 42 / 132 | 58 / 142 |
| serious Total, serious adverse events | 0 / 132 | 0 / 142 |
Outcome results
Primary
Caries Increment
Surface-level dental caries lesions (d2-4mfs) at 24 months post baseline, which is the number of surfaces at 24 months post baseline with cavitation into the enamel (d2), dentin (d3) or pulp (d4), missing due to caries (m) or filled (f).
Time frame: 24 months post baseline
Population: All children with follow-up at 24 months post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Varnish | Caries Increment | 9.8 Number of tooth surfaces | Standard Deviation 10.6 |
| Control Varnish | Caries Increment | 11.3 Number of tooth surfaces | Standard Deviation 10.8 |
p-value: 0.27995% CI: [-4.2, 1.2]t-test, 2 sided
Primary
Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces
Presence/Absence of dental caries lesions (d2-4mfs \>0), which is defined by the presence at 12 months post baseline of 1 or more tooth surfaces with cavitation into the enamel (d2), into the dentin (d3), or into the pulp (d4), missing due to caries (m) or filled (f).
Time frame: 12 months post baseline
Population: All children with follow-up 12 months post-baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Varnish | Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces | 53 Participants |
| Control Varnish | Number of Participants With Caries, Surfaces Missing Due to Caries or Filled Surfaces | 72 Participants |
p-value: 0.02395% CI: [-26.7, -2.1]Chi-squared
Secondary
Adverse Events
Cumulative Adverse and Serious Adverse Events
Time frame: 24 months post baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Varnish | Adverse Events | 42 Participants |
| Control Varnish | Adverse Events | 58 Participants |
p-value: 0.133Fisher Exact