Phase 2
N=284
Efficacy Of A PVP-I Fluoride Varnish
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03082196 ↗Enrolled (actual)
284
Serious AEs
1.8%
Results posted
Sep 2020
Primary outcome: Primary: Dental Caries for Primary Molars Sound at Baseline — 2.3; 3.3 units on a scale — p=0.037
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Test varnish (Drug); Standard varnish (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Advantage Dental Services, LLC
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dental Caries for Primary Molars Sound at Baseline |
2.3; 3.3 | 0.037 sig |
| PRIMARY Dental Caries for All Primary Teeth Sound at Baseline |
2.0; 2.7 | 0.062 |
| SECONDARY Child Response to First Treatment |
2.3; 2.5 | 0.11 |
| SECONDARY Child Response to Fifth Treatment |
2.2; 2.1 | 0.74 |
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.
Eligibility Criteria
Inclusion Criteria
- The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
- The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
- The subject is aged 60-84 months at the time of enrollment.
- The subject must be in good general health as evidenced by parent report.
Exclusion Criteria
- Known allergy to iodine
- Known allergy to seafood
- Known hypersensitivity to fluoride varnish
- Diagnosis of thyroid disease
- Chronic, prophylactic use of antibiotics
- Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.
Data sourced from ClinicalTrials.gov (NCT03082196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.