Povidon-Jod-Wirksamkeitsstudie (PIES)

Objectives:

Primary:

To assess the efficacy of 10% PVPI in children with S-ECC to prevent new caries lesions after oral rehabilitation in the Operating Room (OR) under general anesthesia in children with S-ECC.

The primary outcome variable is time from randomization to relapse. The development of an ICDAS caries code 1 or higher lesion post dental surgery is the sentinel event to calculate time to relapse.

Secondary:

1. To determine incidence and severity of dental caries following oral rehabilitation in the OR.

   This outcome measure will be assessed by counting non-cavitated and cavitated carious lesions and any filled (due to caries), missing (due to caries) and sealed surfaces over the 2-year study period. The International Caries Diagnostic Assessment System (ICDAS) index will be used.

2. To determine diversity and composition of oral microbiota, including cariogenic Streptococcus Mutans, Lactobacilli and Candida species over the 2-year study period.

16S rRNA amplicon analysis of saliva from all participants will be used to identify bacterial taxa associated with dental caries. We will also quantify Colony Forming Units per mL (CFU/mL) of S. mutans, Lactobacilli and Candida species.

3. To determine the frequency of adverse event occurrence. Adverse events (AEs) will be collected from the parent/primary caregiver, as well as those observed by study investigators including unanticipated problems (UPs) and severe adverse events (SAEs) over the 2 year study period.

Population: Healthy children with S-ECC 24 to 71 months of age and their parents/primary caregivers from Rochester NY and the surrounding area will be invited to participate in this study. Enrolled children will be patients of record in the Pediatric Dentistry Division of the Eastman Institute for Oral Health (EIOH), University of Rochester, who require treatment for S-ECC in the OR under general anesthesia.

Phase or Stage: Phase II RCT Number of Sites: 1 site, University of Rochester Description of Intervention: The test agent will be 10% PVPI (Betadine Solution, Purdue Frederick Co., Stamford, CT). The placebo will consist of fluoride-free sterile water for injection USP and commercial powdered tea without sweetener or lemon (Lipton decaffeinated unsweetened tea, Lipton, Unilever, Englewood Cliffs, NJ) with addition of Red and Yellow Food Color (McCormick and Co., Inc., Hunt Valley, MD) to simulate the color of the 10% PVPI.

After drying the teeth, up to 15 µl of 10% PVPI or placebo solution will be applied to the child's teeth with a microbrush. Following application of the test agent (PVPI or placebo), FV (Duraflor®- 5% Sodium Fluoride Varnish, Bubble gum flavor, AMD Medicom, Inc. Quebec, Canada) that is the standard of care will be applied with the manufacturer's supplied applicator.