Povidone Iodine Efficacy Study
ConditionEarly Childhood Caries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age24-71
SponsorUniversity of Rochester
About this trial
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 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
10% povidone iodine + FV
Drugapplied to children's teeth
Placebo +FV
Other interventionapplied to children's teeth
Treatment groups
202 Participants
are divided into 2 treatment groupsGroup A: Povidone IodineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Caries lesion
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.
Time frame
Randomization to relapse, up to 24 monthsSecondary outcomes
1
Incidence and severity of dental caries
To determine incidence and severity of dental caries following oral rehabilitation in the OR.
Time frame
Randomization to relapse, up to 24 months2
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
Time frame
Randomization to relapse, up to 24 months3
Adverse Event Occurrence
To determine the frequency of adverse event occurrence
Time frame
Enrollment to 24 months4
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
Time frame
Randomization to relapse, up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov