Dental Caries
Conditions
Keywords
sodium fluoride, povidone iodine, varnish
Brief summary
The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.
Detailed description
Objectives: Primary \- To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions. Secondary * To establish that the response of child participants to the test varnish was not inferior to the control varnish
Interventions
DRUGTest varnish
Topical application of test varnish to the teeth 4 times per year.
DRUGStandard varnish
Topical application of test varnish to the teeth 4 times per year
Sponsors
Advantage Dental Services, 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, the caries scoring examinations will precede the application of test varnishes at baseline. The staff member applying these varnishes will not perform the caries scoring exams in order to eliminate examiner bias and ensure blinding to treatment assignment. Test drug and comparator are packaged identically.
Intervention model description
Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Eligibility
Sex/Gender
ALL
Age
60 Months to 84 Months
Healthy volunteers
No
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 aged 60-84 months at the time of enrollment. 4. The subject must be in good general health as evidenced by parent report.
Exclusion criteria
1. Known allergy to iodine 2. Known allergy to seafood 3. Known hypersensitivity to fluoride varnish 4. Diagnosis of thyroid disease 5. Chronic, prophylactic use of antibiotics 6. Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Caries for Primary Molars Sound at Baseline | 24 months | The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries. |
| Dental Caries for All Primary Teeth Sound at Baseline | 24 months | The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries. The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Response to First Treatment | After first treatment visit | Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5. |
| Child Response to Fifth Treatment | After fifth treatment visit | Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5. |
Countries
Micronesia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Varnish Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .
Test varnish: Topical application of test varnish to the teeth 4 times per year. | 142 |
| Standard Varnish The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine.
Standard varnish: Topical application of test varnish to the teeth 4 times per year | 142 |
| Total | 284 |
Baseline characteristics
| Characteristic | Test Varnish | Standard Varnish | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 142 Participants | 142 Participants | 284 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants | 142 Participants | 284 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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 | 142 Participants | 284 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Micronesia | 142 participants | 142 participants | 284 participants |
| Sex: Female, Male Female | 76 Participants | 64 Participants | 140 Participants |
| Sex: Female, Male Male | 66 Participants | 78 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 142 | 0 / 142 |
| other Total, other adverse events | 43 / 142 | 49 / 142 |
| serious Total, serious adverse events | 3 / 142 | 2 / 142 |
Outcome results
Primary
Dental Caries for All Primary Teeth Sound at Baseline
The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries. The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth.
Time frame: 24 months
Population: The analysis population is based on participants with sound primary teeth at baseline and follow-up at 24 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Varnish | Dental Caries for All Primary Teeth Sound at Baseline | 2.0 units on a scale | Standard Deviation 2.8 |
| Standard Varnish | Dental Caries for All Primary Teeth Sound at Baseline | 2.7 units on a scale | Standard Deviation 3.3 |
p-value: 0.06295% CI: [-1.5, 0.1]t-test, 2 sided
Primary
Dental Caries for Primary Molars Sound at Baseline
The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries.
Time frame: 24 months
Population: The analysis population is based on the 139 participants with sound molars and baseline and follow-up at 24-months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Varnish | Dental Caries for Primary Molars Sound at Baseline | 2.3 units on a scale | Standard Deviation 2.8 |
| Standard Varnish | Dental Caries for Primary Molars Sound at Baseline | 3.3 units on a scale | Standard Deviation 2.7 |
p-value: 0.03795% CI: [-1.9, -0.1]t-test, 2 sided
Secondary
Child Response to Fifth Treatment
Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5.
Time frame: After fifth treatment visit
Population: Analysis population based on participants who received the fifth varnish application and completed the Facial Image Scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Varnish | Child Response to Fifth Treatment | 2.2 units on a scale | Standard Deviation 1.1 |
| Standard Varnish | Child Response to Fifth Treatment | 2.1 units on a scale | Standard Deviation 1.2 |
p-value: 0.7495% CI: [-0.2, 0.3]t-test, 2 sided
Secondary
Child Response to First Treatment
Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5.
Time frame: After first treatment visit
Population: The analysis population is based on participants who received the first varnish application and completed the Facial Image Scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Varnish | Child Response to First Treatment | 2.3 units on a scale | Standard Deviation 1.2 |
| Standard Varnish | Child Response to First Treatment | 2.5 units on a scale | Standard Deviation 1.3 |
p-value: 0.1195% CI: [-0.5, 0.1]t-test, 2 sided