Early Childhood Caries Clinical Trial
— PIESOfficial title:
Povidone Iodine Efficacy Study
This is a single center, randomized, double-blind, placebo-controlled Phase II clinical trial (RCT) to evaluate the efficacy of topical 10% Polyvinylpyrrolidone-Iodine (PVPI) to prevent new cavitated caries lesions when applied to the teeth of children with Severe Early Childhood Caries (S-ECC). At baseline, following oral rehabilitation in the operating room {10% (PVPI + Fluoride Varnish (FV)} will be compared to the current standard of care (Placebo + FV). Study participants will be followed for approximately 24 months post-baseline. The study interventions post-baseline will be administered at 3, 6, 9, 12, 15, 18, and 21 months.
Status | Recruiting |
Enrollment | 246 |
Est. completion date | May 2027 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 24 Months to 71 Months |
Eligibility | Inclusion Criteria: - Provide signed and dated informed consent/permission form - Parents/primary caregivers willing to comply with all study procedures and be available for the duration of the study - Male or female, of any race, ethnicity, aged 24 to 71 months and their parents/primary caregivers who are 18 years of age or older or emancipated minors - In good general health as evidenced by medical history, per PI, and in compliance with current CDC, NYS Department of Health and URMC COVID-19 guidelines. American Society of Anesthesiologists (ASA) categories will be used; children classified as ASA I and ASA II will be eligible for the study. - Diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room (OR). A diagnosis of S-ECC will be based on the definition in accordance with American Academy of Pediatric Dentistry (AAPD) Exclusion Criteria: - Having a known allergy or sensitivity to iodine or seafood, red or yellow food coloring, or to tea, including a hypersensitivity to fluoride varnish, or having thyroid disease, as determined by medical history - Receiving or having received treatment with another investigational drug within 30 days of the baseline visit (V1) |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caries lesion | The primary outcome variable is time from randomization to relapse. The development of an ICDAS caries code 3 (cavitated caries lesion) or higher lesion post dental surgery is the sentinel event to calculate time to relapse. | Randomization to relapse, up to 24 months | |
Secondary | Incidence and severity of dental caries | To determine incidence and severity of dental caries following oral rehabilitation in the OR. | Randomization to relapse, up to 24 months | |
Secondary | Diversity of oral microbiota | To determine diversity of oral microbiota, including cariogenic Streptococcus Mutans, Lactobacilli and Candida species over the 2-year study period. Concentration (CFU/ml) will be measured | Randomization to relapse, up to 24 months | |
Secondary | Adverse Event Occurrence | To determine the frequency of adverse event occurrence | Enrollment to 24 months | |
Secondary | Composition of Microbiota | To determine composition of oral microbiota, including cariogenic Streptococcus Mutans, Lactobacilli and Candida species over the 2-year study period. Presence of species (yes or no) will be measured | Randomization to relapse, up to 24 months |
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