Povidone Iodine for Caries Prevention

NCT07741409 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: 202601408N063700-G
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.How will home use of Povidone Iodine, as an adjunct treatment to standard dental care, reduce the incidence of tooth decay?
2. 2.How will home use of Povidone Iodine reduce the mouth germs responsible for tooth decay?
3. 3.If Povidone Iodine use is accompanied by probiotic use, will its effectiveness be even better than Povidone Iodine alone?
4. 4.Provide a plaque sample at the beginning of the study.
5. 5.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.
6. 6.Keep a record of compliance.
7. 7.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

Conditions

Dental Caries

Keywords

Dental Caries; Povidone Iodine; Probiotics

Outcome Measures

Primary Outcomes (1)

• Prevention of Dental Caries

  Change in the incidence of dental caries compared to placebo

  Minimum 6 months; maximum 12 months

Secondary Outcomes (1)

• Microbiome

  Minimum 6 months; maximum 12 months

Study Arms (3)

PI Alone

EXPERIMENTAL

This arm will be Povidone Iodine alone.

Drug: Povidone Iodine 5% Soln,Top,Kit

PI plus Probiotics

ACTIVE COMPARATOR

This arm will determine if/how well probiotics improve the effect of the Povidone Iodine

Drug: Povidone Iodine 5% Soln,Top,Kit; Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Placebo for the Povidone Iodine

Drug: Placebo

Interventions

Povidone Iodine 5% Soln,Top,Kit DRUG

Home use of Povidone Iodine administered by swabbing teeth; weekly for the 1st month, monthly thereafter.

PI Alone; PI plus Probiotics

Probiotics DIETARY_SUPPLEMENT

Home use of Povidone Iodine coupled with daily use of a probiotic.

PI plus Probiotics

Placebo DRUG

Placebo for the Povidone Iodine

Placebo

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 3 years of age
• No plans to relocate in the next 12 months

You may not qualify if:

• Thyroid condition
• Antibiotic usage in the prior 3 months

Sponsors & Collaborators

• Jeffrey A. Banas: lead

Study Sites (1)

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

Related Publications (17)

• Milgrom P, Tut O, Rothen M, Mancl L, Gallen M, Tanzer JM. Addition of Povidone-Iodine to Fluoride Varnish for Dental Caries: A Randomized Clinical Trial. JDR Clin Trans Res. 2021 Apr;6(2):195-204. doi: 10.1177/2380084420922968. Epub 2020 May 21.

  PMID: 32437626 BACKGROUND

• Lyashenko C, Herrman E, Irwin J, James A, Strauss S, Warner J, Khor B, Snow M, Ortiz S, Waid E, Nasry B, Chai J, Choong C, Palmer E, Kutsch K, Forsyth A, Choi D, Maier T, Machida CA. Adjunctive dental therapies in caries-active children: Shifting the cariogenic salivary microbiome from dysbiosis towards non-cariogenic health. Hum Microb J. 2020 Dec;18:100077. doi: 10.1016/j.humic.2020.100077. Epub 2020 Aug 31.

  PMID: 34485763 BACKGROUND

• Li Y, Tanner A. Effect of Antimicrobial Interventions on the Oral Microbiota Associated with Early Childhood Caries. Pediatr Dent. 2015 May-Jun;37(3):226-44.

  PMID: 26063552 BACKGROUND

• Muntean A, Mzoughi SM, Pacurar M, Candrea S, Inchingolo AD, Inchingolo AM, Ferrante L, Dipalma G, Inchingolo F, Palermo A, Bordea IR. Silver Diamine Fluoride in Pediatric Dentistry: Effectiveness in Preventing and Arresting Dental Caries-A Systematic Review. Children (Basel). 2024 Apr 22;11(4):499. doi: 10.3390/children11040499.

  PMID: 38671716 BACKGROUND

• Papas AS, Vollmer WM, Gullion CM, Bader J, Laws R, Fellows J, Hollis JF, Maupome G, Singh ML, Snyder J, Blanchard P; PACS Collaborative Group. Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial. J Dent Res. 2012 Feb;91(2):150-5. doi: 10.1177/0022034511424154. Epub 2011 Dec 7.

  PMID: 22156917 BACKGROUND

• Bokulich NA, Kaehler BD, Rideout JR, Dillon M, Bolyen E, Knight R, Huttley GA, Gregory Caporaso J. Optimizing taxonomic classification of marker-gene amplicon sequences with QIIME 2's q2-feature-classifier plugin. Microbiome. 2018 May 17;6(1):90. doi: 10.1186/s40168-018-0470-z.

  PMID: 29773078 BACKGROUND

• Sulyanto RM, Beall CJ, Berger MT, Goodell CP, Koo S, Candamo F, Dickson JR, Kang M, Ho SP, Ng MW, Hashmi SB, Leys EJ, Griffen AL. Silver diamine fluoride alters microbial communities in subsurface dentin. JADA Found Sci. 2022 Feb 8;1:100004. doi: 10.1016/j.jfscie.2021.100004. eCollection 2022.

  PMID: 42238656 BACKGROUND

• Zhang JS, Chen Z, Chu CH, Yu OY. Effect of silver diamine fluoride upon the microbial community of carious lesions: A scoping review. J Dent. 2023 Jul;134:104554. doi: 10.1016/j.jdent.2023.104554. Epub 2023 May 21.

  PMID: 37220834 BACKGROUND

• Weber-Gasparoni K, Kanellis MJ, Qian F. Iowa's public health-based infant oral health program: a decade of experience. J Dent Educ. 2010 Apr;74(4):363-71.

  PMID: 20388808 BACKGROUND

• Ribeiro AA, Paster BJ. Dental caries and their microbiomes in children: what do we do now? J Oral Microbiol. 2023 Apr 10;15(1):2198433. doi: 10.1080/20002297.2023.2198433. eCollection 2023.

  PMID: 37056224 BACKGROUND

• Mitwalli H, Mourao MDA, Dennison J, Yaman P, Paster BJ, Fontana M. Effect of Silver Diamine Fluoride Treatment on Microbial Profiles of Plaque Biofilms from Root/Cervical Caries Lesions. Caries Res. 2019;53(5):555-566. doi: 10.1159/000499578. Epub 2019 May 28.

  PMID: 31137026 BACKGROUND

• Mei ML, Yan Z, Duangthip D, Niu JY, Yu OY, You M, Lo ECM, Chu CH. Effect of silver diamine fluoride on plaque microbiome in children. J Dent. 2020 Nov;102:103479. doi: 10.1016/j.jdent.2020.103479. Epub 2020 Sep 17.

  PMID: 32950631 BACKGROUND

• Lopez L, Berkowitz R, Spiekerman C, Weinstein P. Topical antimicrobial therapy in the prevention of early childhood caries: a follow-up report. Pediatr Dent. 2002 May-Jun;24(3):204-6.

  PMID: 12064491 BACKGROUND

• Kotha A, Vemulapalli A, Mandapati SR, Aryal S. Prevalence, Trends, and Severity of Early Childhood Caries in The United States: National Health and Nutritional Examination Survey Data 2013 to 2018. Pediatr Dent. 2022 Jul 15;44(4):261-268.

  PMID: 35999681 BACKGROUND

• Frank S, Capriotti J, Brown SM, Tessema B. Povidone-Iodine Use in Sinonasal and Oral Cavities: A Review of Safety in the COVID-19 Era. Ear Nose Throat J. 2020 Nov;99(9):586-593. doi: 10.1177/0145561320932318. Epub 2020 Jun 10.

  PMID: 32520599 BACKGROUND

• Simratvir M, Singh N, Chopra S, Thomas AM. Efficacy of 10% Povidone Iodine in children affected with early childhood caries: an in vivo study. J Clin Pediatr Dent. 2010 Spring;34(3):233-8. doi: 10.17796/jcpd.34.3.l552816527xtv122.

  PMID: 20578661 BACKGROUND

• Amin MS, Harrison RL, Benton TS, Roberts M, Weinstein P. Effect of povidone-iodine on Streptococcus mutans in children with extensive dental caries. Pediatr Dent. 2004 Jan-Feb;26(1):5-10.

  PMID: 15080351 BACKGROUND

Related Links

• Practitioner who used Povidone Iodine for caries prevention

MeSH Terms

Conditions

Dental Caries

Interventions

Povidone-Iodine; Probiotics

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Jeffrey Banas, PHD

CONTACT

+1 319 335 9911; jeffrey-banas@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 3, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)