Health TrialsbyHealthPanel

Povidone Iodine for Caries Prevention

ConditionDental Caries
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-3
SponsorJeffrey A. Banas

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1 to 3 years of age

No plans to relocate in the next 12 months

Disqualifiers

Thyroid condition

Antibiotic usage in the prior 3 months

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

174 Participants
are divided into 3 treatment groups
Group A: PI AloneExperimental treatment 1 intervention
Group B: PI plus ProbioticsActive comparator 2 interventions
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Prevention of Dental Caries

Change in the incidence of dental caries compared to placebo

Time frame
Minimum 6 months; maximum 12 months

Secondary outcomes

1

Microbiome

Change in the cariogenic potential of the plaque microbiome compared to the placebo.

Time frame
Minimum 6 months; maximum 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jeffrey A. Banas

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: