Dental CariesPhase 2NCT03082196

Efficacy Of A PVP-I Fluoride Varnish

A Phase 2 study testing Test varnish and Standard varnish in people with Dental Caries, run by Advantage Dental Services, LLC at 1 site in Micronesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 84 months
Conditions the study is for: Dental Caries
What is being tested?: Test varnish and Standard varnish
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 284 participants
Where: 1 siteMicronesia
Study dates: 30 Mar 2017to 7 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 to 84 months
All sexes
No healthy volunteers
Child

Who may be able to join

The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
The subject is aged 60-84 months at the time of enrollment.
The subject must be in good general health as evidenced by parent report.

Who cannot join

Known allergy to iodine
Known allergy to seafood
Known hypersensitivity to fluoride varnish
Diagnosis of thyroid disease
Chronic, prophylactic use of antibiotics
Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.

Trial locations and contacts

1 site in 1 country.

Micronesia1 site

Pohnpei State Hospital
Kolonia, Pohnpei State, 96941

About this study

Official title: Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish

The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.

Read the detailed description

Objectives:

Primary

To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions.

Secondary

To establish that the response of child participants to the test varnish was not inferior to the control varnish

Conditions: Dental Caries
Being tested: Test varnish, Standard varnish
Keywords: sodium fluoride, povidone iodine, varnish
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test varnishDrug
Topical application of test varnish to the teeth 4 times per year.
Standard varnishDrug
Also called sodium fluoride varnish
Topical application of test varnish to the teeth 4 times per year

Study groups in NCT03082196
Study group	Role	What they receive
Test varnish	Experimental	Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride . Receives: Drug: Test varnish
Standard varnish	Active comparator	The active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine. Receives: Drug: Standard varnish

What is being measured

The primary outcome is the main question the study is designed to answer.

Dental Caries for Primary Molars Sound at Baseline
The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries.
Measured: 24 months
Dental Caries for All Primary Teeth Sound at Baseline
The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries.
The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth.
Measured: 24 months

Secondary outcomes (2)

Child Response to First Treatment
Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5.
Measured: After first treatment visit
Child Response to Fifth Treatment
Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5.
Measured: After fifth treatment visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 20177 May 2019

First posted17 Mar 2017
Study start30 Mar 2017
Primary completion7 May 2019
Study completion7 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03082196
Sponsor's protocol ID: 2016-12-02
Status last verified: Sep 2020
First submitted: 13 Mar 2017
Last updated: 10 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32437626
Milgrom P, Tut O, Rothen M, Mancl L, Gallen M, Tanzer JM. Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial. BMJ Open. 2017 Jun 30;7(6):e017866. doi: 10.1136/bmjopen-2017-017866.
PubMed 28667230

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish
ClinicalTrials.gov ID: NCT03082196
Acronym / sponsor ID: 2016-12-02
Conditions: Dental Caries
Keywords: sodium fluoride, povidone iodine, varnish
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 284 participants (actual)
Lead sponsor: Advantage Dental Services, LLCIndustry (pharma, biotech, devices)
Study start: 30 Mar 2017 (actual)
Primary completion: 7 May 2019 (actual)
Study completion: 7 May 2019 (actual)
First posted: 17 Mar 2017 (actual)
Results: Posted 10 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives:

Primary

To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions.

Secondary

To establish that the response of child participants to the test varnish was not inferior to the control varnish

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.

Arm	Type	Receives
Test varnish	Experimental	Drug: Test varnishAdvantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .
Standard varnish	Active comparator	Drug: Standard varnishThe active control varnish will be the same fluoride varnish without iodine with an appropriate FDA approved food dye added to match the color of the test agent. There will be no difference in the treatment and control varnishes except for the povidone iodine.

Who may qualify

Ages: 60 to 84 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
The subject is aged 60-84 months at the time of enrollment.
The subject must be in good general health as evidenced by parent report.

Key exclusion criteria (6 listed)

Known allergy to iodine
Known allergy to seafood
Known hypersensitivity to fluoride varnish
Diagnosis of thyroid disease
Chronic, prophylactic use of antibiotics

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
Test varnishTopical application of test varnish to the teeth 4 times per year.	Drug	Test varnish
Standard varnishAlso: sodium fluoride varnishTopical application of test varnish to the teeth 4 times per year	Drug	Standard varnish

Primary outcome

Dental Caries for Primary Molars Sound at Baseline
Time frame: 24 months
The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries.
Dental Caries for All Primary Teeth Sound at Baseline
Time frame: 24 months
The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries. The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth.

2 secondary outcomes

Child Response to First Treatment
Time frame: After first treatment visit
Child Response to Fifth Treatment
Time frame: After fifth treatment visit

Results and safety

Results posted to the registry on 10 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Varnish	142	133
Standard Varnish	142	129

Primary outcome: Dental Caries for Primary Molars Sound at Baseline

Time frame: 24 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Test Varnish n = 72	Standard Varnish n = 67
Value	2.3 (2.8)	3.3 (2.7)

Test Varnish vs Standard Varnish: Mean Difference (Final Values): -1.0 (95% CI -1.9 to -0.1), p = 0.037, t-test, 2 sided

Population analysed: The analysis population is based on the 139 participants with sound molars and baseline and follow-up at 24-months.

Primary outcome: Dental Caries for All Primary Teeth Sound at Baseline

Time frame: 24 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Test Varnish n = 126	Standard Varnish n = 116
Value	2.0 (2.8)	2.7 (3.3)

Test Varnish vs Standard Varnish: Mean Difference (Final Values): -0.7 (95% CI -1.5 to 0.1), p = 0.062, t-test, 2 sided

Population analysed: The analysis population is based on participants with sound primary teeth at baseline and follow-up at 24 months.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Varnish	3 of 142 (2.1%)	43 of 142 (30.3%)	0 of 142
Standard Varnish	2 of 142 (1.4%)	49 of 142 (34.5%)	0 of 142

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32437626Milgrom 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.
Derived from this study: PubMed 28667230Milgrom P, Tut O, Rothen M, Mancl L, Gallen M, Tanzer JM. Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial. BMJ Open. 2017 Jun 30;7(6):e017866. doi: 10.1136/bmjopen-2017-017866.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Peter M Milgrom, DDS study chair

Advantage Silver Dental Arrest, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Test varnish and Standard varnish in people with Dental Caries, run by Advantage Dental Services, LLC at 1 site in Micronesia.

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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Micronesia. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dental Caries for Primary Molars Sound at Baseline (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT03082196, which also lists 2 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 10 Sep 2020.