Early Childhood CariesPhase 2PIESNCT05272254
Povidone Iodine Efficacy Study
A Phase 2 study testing 10% povidone iodine + FV in people with Early Childhood Caries, run by University of Rochester at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 24 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- 10% povidone iodine + FV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this 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 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.
Read the detailed description
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:
- 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.
- 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.
- 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.
- Conditions
- Early Childhood Caries
- Being tested
- 10% povidone iodine + FV, Placebo +FV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% povidone iodine + FVDrug
Also called betadine
applied to children's teeth
Placebo +FVOther
Also called Iced tea
applied to children's teeth
| Study group | Role | What they receive |
|---|---|---|
| Povidone Iodine | Experimental | 10% povidone iodine + fluoride varnish Receives: Drug: 10% povidone iodine + FV |
| Placebo | Placebo comparator | Placebo (iced tea) + fluoride varnish Receives: Other: Placebo +FV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to relapse, up to 24 months
Secondary outcomes (4)
Incidence and severity of dental caries
To determine incidence and severity of dental caries following oral rehabilitation in the OR.
Measured: Randomization to relapse, up to 24 months
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
Measured: Randomization to relapse, up to 24 months
Adverse Event Occurrence
To determine the frequency of adverse event occurrence
Measured: Enrollment to 24 months
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
Measured: Randomization to relapse, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start15 Sep 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorota Kopycka-Kedzierawski, University of Rochester
- Investigators
- Dorota T Kopycka-Kedzierawski, DDS, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272254
- Sponsor's protocol ID
- STUDY00007064
- Other IDs
- 21-057-E
- Acronym
- PIES
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Povidone Iodine Efficacy Study
- ClinicalTrials.gov ID
- NCT05272254
- Acronym / sponsor ID
- PIES / STUDY00007064
- Conditions
- Early Childhood Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Povidone Iodine | Experimental | Drug: 10% povidone iodine + FV10% povidone iodine + fluoride varnish |
| Placebo | Placebo comparator | Other: Placebo +FVPlacebo (iced tea) + fluoride varnish |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% povidone iodine + FVAlso: betadineapplied to children's teeth | Drug | Povidone Iodine |
| Placebo +FVAlso: Iced teaapplied to children's teeth | Other | Placebo |
Primary outcome
Caries lesion
Time frame: Randomization to relapse, up to 24 months
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.
4 secondary outcomes
Incidence and severity of dental caries
Time frame: Randomization to relapse, up to 24 months
Diversity of oral microbiota
Time frame: Randomization to relapse, up to 24 months
Adverse Event Occurrence
Time frame: Enrollment to 24 months
Composition of Microbiota
Time frame: Randomization to relapse, up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorota T Kopycka-Kedzierawski, DDS, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10% povidone iodine + FV in people with Early Childhood Caries, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries lesion (time frame: Randomization to relapse, up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.