Sequential PVP-I and FV

June 28, 2026 updated by: Peter Milgrom, Advantage Silver Dental Arrest, LLC

Sequential Application of PVP-I and Fluoride Varnish: A Prospective Cohort Study

This prospective cohort study in children will determine if: topical povidone iodine 10% followed by topical fluoride varnish is superior to placebo iodine followed two different varnishes alone to prevent tooth decay (dental caries).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives:

  1. To determine if sequential topical application of Povidone Iodine (Povi-One, 10% PVP-I) followed by the Fluoride Varnish (Fluorimax, 2.5% NaF) every 3 months is superior to an active control (placebo + standard of care FV (Fluorimax) at 24 months post baseline. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline.
  2. To determine if the sequential topical application of Povidone Iodine (Povi-One, 10% PVP-I) followed by the Fluoride Varnish (Fluorimax, 2.5% NaF) every 3 months is superior to active control (placebo + ClinPro Clear Fluoride Treatment (Solventum, 2.1% NaF) at 24 months post baseline. Specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline.

Secondary Objective:

To determine if sequential topical application of placebo followed by the Fluoride Varnish (Fluorimax, 2.5% NaF) every 3 months is superior to placebo followed by Clinpro Clear Fluoride Treatment (Solventum, 2.1% NaF) at 24 months post baseline.

Study Design: Open label prospective cohort study. The study will be conducted in two hospitals in Puno serving the "Control de Crecimiento y Desarrollo (CRED)" program, conducted under the Ministry of Health. The treatment at each site will be the same with different treatments on different days of the week chosen randomly, stratified by hospital. There will be no individual randomization.

Participants: Children 6-24 months of age at enrollment. To be eligible a child will have at least 1 erupted tooth that is either sound or has only a d1 (white spot) lesion. Children will be excluded under the following conditions:

  1. Previous treatment with fluoride varnish
  2. Known allergy to iodine
  3. Diagnosis of thyroid disease
  4. Chronic, prophylactic use of antibiotics
  5. Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.
  6. Visible cavities (d2-4) in the erupted primary teeth
  7. Presence of intraoral soft tissue pathology (gum boil)
  8. Parent anticipates the child will move from current city during the next 24 months.

Products Being Studied:

The 10% PVP-I (Povi-One) and 2.5% FV (Fluorimax) will be obtained from Elevate Oral Care, LLC., West Palm Beach, FL USA. The ClinPro Clear (2.1% NaF) will be purchased in the marketplace by Elevate and made available to the study.

Study Type

Observational

Enrollment (Estimated)

393

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children served by two health centers in Puno serving the "Control de Crecimiento y Desarrollo (CRED)" program and the Faculty of Health Sciences, Professional School of Dentistry, National University of the Altiplano, Puno, Peru.

Description

Inclusion Criteria:

  • Children 6-24 months of age at enrollment. To be eligible a child will have at least 1 erupted tooth that is either sound or has only a d1 (white spot) lesion.

Exclusion Criteria:

  1. Previous treatment with fluoride varnish
  2. Known allergy to iodine
  3. Diagnosis of thyroid disease
  4. Chronic, prophylactic use of antibiotics
  5. Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.
  6. Visible cavities (d2-4) in the erupted primary teeth
  7. Presence of intraoral soft tissue pathology (gum boil)
  8. Parent anticipates the child will move from current city during the next 24 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Povi+Fluorimax
Topical 10% Povidone Iodine followed by Fluorimax Fluoride Varnish Applied to the Teeth
Device: fluoride varnish, 2.5%
sodium fluoride, 2.5%
Drug: Povidone Iodine Topical
Povidone Iodine, 10%
Placebo+Fluorimax
Topical Placebo followed by Fluorimax Fluoride Varnish Applied to the Teeth
Device: fluoride varnish, 2.5%
sodium fluoride, 2.5%
Placebo+ClinPro
Topical Placebo followed by ClinPro Clear Fluoride Applied to the Teeth
Device: topical fluoride, 2.1%
sodium fluoride, 2.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface level caries
Time Frame: 24 months
d2-4mfs
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/Absence of dental caries lesions
Time Frame: 24 months
d2-4mfs>0
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advantage Silver Dental Arrest, LLC

Collaborators

University of Washington
Universidad Nacional del Altiplano de Puno

Investigators

  • Principal Investigator: Tania Caceres Padilla, DDS, Universidad Nacional del Altiplano de Puno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

June 28, 2026

First Submitted That Met QC Criteria

June 28, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 28, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Povi 2026-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant level data will be made available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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