Dental CariesNCT07683910
Sequential PVP-I and FV
An observational study of Dental Caries, run by Advantage Silver Dental Arrest, LLC.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- fluoride varnish, 2.5%, topical fluoride, 2.1% and Povidone Iodine Topical
- Type of treatment
- Medical device
- How many people
- 393 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2029
- Phase
- Observational
- 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 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the detailed description
Primary Objectives:
- 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.
- 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:
- 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.
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.
- Conditions
- Dental Caries
- Being tested
- fluoride varnish, 2.5%, topical fluoride, 2.1%, Povidone Iodine Topical
- Keywords
- Early Childhood Caries, Fluoride Varnish, Povidone-Iodine
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoride varnish, 2.5%Device
sodium fluoride, 2.5%
topical fluoride, 2.1%Device
sodium fluoride, 2.1%
Povidone Iodine TopicalDrug
Povidone Iodine, 10%
| Study group | Role | What they receive |
|---|---|---|
| Povi+Fluorimax | Topical 10% Povidone Iodine followed by Fluorimax Fluoride Varnish Applied to the Teeth Receives: Device: fluoride varnish, 2.5%; Drug: Povidone Iodine Topical | |
| Placebo+Fluorimax | Topical Placebo followed by Fluorimax Fluoride Varnish Applied to the Teeth Receives: Device: fluoride varnish, 2.5% | |
| Placebo+ClinPro | Topical Placebo followed by ClinPro Clear Fluoride Applied to the Teeth Receives: Device: topical fluoride, 2.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface level caries
d2-4mfs
Measured: 24 months
Secondary outcomes (1)
Presence/Absence of dental caries lesions
d2-4mfs>0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 393 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advantage Silver Dental Arrest, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Nacional del Altiplano de Puno, University of Washington
- Responsible party
- Principal investigator, Peter Milgrom, Advantage Silver Dental Arrest, LLC
- Investigators
- Tania Caceres Padilla, DDS, Principal investigator, Universidad Nacional del Altiplano de Puno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683910
- Sponsor's protocol ID
- Povi 2026-1
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified participant level data will be made available upon request
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.
PubMed 26011444Padilla 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.
PubMed 38678451Broadbent 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.
PubMed 16262607
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Application of PVP-I and Fluoride Varnish: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07683910
- Acronym / sponsor ID
- Povi 2026-1
- Conditions
- Dental Caries
- Keywords
- Early Childhood Caries, Fluoride Varnish, Povidone-Iodine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 393 participants (estimated)
- Lead sponsor
- Advantage Silver Dental Arrest, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Nacional del Altiplano de Puno, University of Washington
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 6 Jul 2026 (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 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:
- 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.
- 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:
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Povi+Fluorimax | – | Device: fluoride varnish, 2.5%, Drug: Povidone Iodine TopicalTopical 10% Povidone Iodine followed by Fluorimax Fluoride Varnish Applied to the Teeth |
| Placebo+Fluorimax | – | Device: fluoride varnish, 2.5%Topical Placebo followed by Fluorimax Fluoride Varnish Applied to the Teeth |
| Placebo+ClinPro | – | Device: topical fluoride, 2.1%Topical Placebo followed by ClinPro Clear Fluoride Applied to the Teeth |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| fluoride varnish, 2.5%sodium fluoride, 2.5% | Device | Placebo+Fluorimax, Povi+Fluorimax |
| topical fluoride, 2.1%sodium fluoride, 2.1% | Device | Placebo+ClinPro |
| Povidone Iodine TopicalPovidone Iodine, 10% | Drug | Povi+Fluorimax |
Primary outcome
Surface level caries
Time frame: 24 months
d2-4mfs
1 secondary outcome
Presence/Absence of dental caries lesions
Time frame: 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 6 Jul 2026.
- BackgroundSchafer JL. Analysis of Incomplete Multivariate Data. London: Chapman & Hall, 1997.
- Background: PubMed 26011444Warren 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.
- Background: PubMed 38678451Padilla 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.
- Background: PubMed 16262607Broadbent 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.
- Individual participant dataSharing planned: Yes. Deidentified participant level data will be made available upon request
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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.
Tania Caceres Padilla, DDS principal investigator
Universidad Nacional del Altiplano de Puno
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Advantage Silver Dental Arrest, LLC.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Peter Milgrom, DDS (206-251-6831, drmilgrom@silverarrest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface level caries (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07683910, which also lists 4 linked publications.
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 6 Jul 2026.