Povidone Iodine for Caries Prevention

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Jeffrey A. Banas
Study ID
NCT07741409
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Dental Caries

Eligibility Criteria

Sex
ALL
Age
1 Year - 3 Years
Healthy Volunteers
Accepted

Interventions

  • Povidone Iodine 5% Soln,Top,Kit — DRUG
    Home use of Povidone Iodine administered by swabbing teeth; weekly for the 1st month, monthly thereafter.
  • Probiotics — DIETARY_SUPPLEMENT
    Home use of Povidone Iodine coupled with daily use of a probiotic.
  • Placebo — DRUG
    Placebo for the Povidone Iodine

Study Details

The goal of this clinical trial is to learn if Povidone Iodine works to prevent tooth decay and suppress the mouth germs responsible for tooth decay. The main questions it aims to answer are: 1. How will home use of Povidone Iodine, as an adjunct treatment to standard dental care, reduce the incidence of tooth decay? 2. How will home use of Povidone Iodine reduce the mouth germs responsible for tooth decay? 3. If Povidone Iodine use is accompanied by probiotic use, will its effectiveness be even better than Povidone Iodine alone? Participants will: 1. Provide a plaque sample at the beginning of the study. 2. Swab their children's teeth once a week for one month and then monthly thereafter. Some participants may be asked to use probiotic drops nightly after brushing their teeth. 3. Keep a record of compliance. 4. Return every 6 months for a dental exam and to provide a plaque sample. Keep a diary of their symptoms and the number of times they use a rescue inhaler

Key Dates

First listed
Aug 3, 2026
Start date
Aug 3, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: PI Alone
    This arm will be Povidone Iodine alone.
  • Active Comparator: PI plus Probiotics
    This arm will determine if/how well probiotics improve the effect of the Povidone Iodine
  • Placebo Comparator: Placebo
    Placebo for the Povidone Iodine

Primary Outcome Measure

Prevention of Dental Caries [ Time Frame: Minimum 6 months; maximum 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa College of DentistryIowa CityIowa52242
Jeffrey A Banas, PhD
[email protected]
319-335-9911
Michael J Kanellis, DDS
[email protected]
319-335-7439

Find similar trials in Iowa City, IA

By research site
University of Iowa College of Dentistry· Iowa City, IA

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