NCT07683910

Brief Summary

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
393

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Sep 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

June 28, 2026

Last Update Submit

June 28, 2026

Conditions

Dental Caries

Keywords

Early Childhood CariesFluoride VarnishPovidone-Iodine

Outcome Measures

Primary Outcomes (1)

  • Surface level caries

    d2-4mfs

    24 months

Secondary Outcomes (1)

  • Presence/Absence of dental caries lesions

    24 months

Study Arms (3)

Povi+Fluorimax

Topical 10% Povidone Iodine followed by Fluorimax Fluoride Varnish Applied to the Teeth

Device: fluoride varnish, 2.5%Drug: Povidone Iodine Topical

Placebo+Fluorimax

Topical Placebo followed by Fluorimax Fluoride Varnish Applied to the Teeth

Device: fluoride varnish, 2.5%

Placebo+ClinPro

Topical Placebo followed by ClinPro Clear Fluoride Applied to the Teeth

Device: topical fluoride, 2.1%

Interventions

fluoride varnish, 2.5%DEVICE

sodium fluoride, 2.5%

Placebo+FluorimaxPovi+Fluorimax
topical fluoride, 2.1%DEVICE

sodium fluoride, 2.1%

Placebo+ClinPro
Povidone Iodine TopicalDRUG

Povidone Iodine, 10%

Povi+Fluorimax

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Schafer JL. Analysis of Incomplete Multivariate Data. London: Chapman & Hall, 1997.

    BACKGROUND

  • Warren JJ, Weber-Gasparoni K, Tinanoff N, Batliner TS, Jue B, Santo W, Garcia RI, Gansky SA; Early Childhood Caries Collaborating Centers. Examination criteria and calibration procedures for prevention trials of the Early Childhood Caries Collaborating Centers. J Public Health Dent. 2015 Fall;75(4):317-26. doi: 10.1111/jphd.12102. Epub 2015 May 22.

    PMID: 26011444BACKGROUND

  • Padilla Caceres TC, Cervantes-Alagon S, Castillo JL, Vera Reyes CM, Rothen M, Mancl LA, Milgrom P. Using sequential applications of a novel silver diamine fluoride gel and sodium fluoride varnish to arrest severe early childhood caries lesions: A clinical trial with single group assignment. J Am Dent Assoc. 2024 Jun;155(6):526-535. doi: 10.1016/j.adaj.2024.02.013. Epub 2024 Apr 25.

    PMID: 38678451BACKGROUND

  • Broadbent JM, Thomson WM. For debate: problems with the DMF index pertinent to dental caries data analysis. Community Dent Oral Epidemiol. 2005 Dec;33(6):400-9. doi: 10.1111/j.1600-0528.2005.00259.x.

    PMID: 16262607BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Tania Caceres Padilla, DDS

    Universidad Nacional del Altiplano de Puno

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Milgrom, DDS

CONTACT

206-251-6831drmilgrom@silverarrest.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

June 28, 2026

First Posted

July 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Deidentified participant level data will be made available upon request