Sequential PVP-I and FV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fluoride varnish, 2.5%, topical fluoride, 2.1%, Povidone Iodine Topical.
- Who it may be relevant to
- Registry conditions: Dental Caries. Basic parameters: 6 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sequential Application of PVP-I and Fluoride Varnish: A Prospective Cohort Study
Overview
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).
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.
Interventions
- Device fluoride varnish, 2.5%
sodium fluoride, 2.5% - Device topical fluoride, 2.1%
sodium fluoride, 2.1% - Drug Povidone Iodine Topical
Povidone Iodine, 10%
Primary outcome measures
- Surface level caries [Time frame: 24 months]
Secondary outcome measures (1)
- Presence/Absence of dental caries lesions [Time frame: 24 months]
Eligibility criteria
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Schafer JL. Analysis of Incomplete Multivariate Data. London: Chapman & Hall, 1997.
- 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 26011444
- 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 38678451
- 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 16262607
Identifiers
NCT: NCT07683910 · Povi 2026-1