Efficacy Of A PVP-I Fluoride Varnish

NCT03082196 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2016-12-02
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

sodium fluoride; povidone iodine; varnish

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 months

Secondary Outcomes (2)

• Child Response to First Treatment

  After first treatment visit

• Child Response to Fifth Treatment

  After fifth treatment visit

Study Arms (2)

Test varnish

EXPERIMENTAL

Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .

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.

Drug: Standard varnish

Interventions

Test varnish DRUG

Topical application of test varnish to the teeth 4 times per year.

Test varnish

Standard varnish DRUG

Topical application of test varnish to the teeth 4 times per year

Also known as: sodium fluoride varnish

Standard varnish

Eligibility Criteria

• Age: 60 Months - 84 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advantage Dental Services, LLC: lead

Study Sites (1)

Pohnpei State Hospital

Kolonia, Pohnpei State, 96941, Micronesia

Location

Related Publications (2)

• 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 DERIVED

• 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.

  PMID: 28667230 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Bifluorid 12

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Peter Milgrom
• Organization: Advantage Silver Dental Arrest, LLC

drmilgrom@silverarrest.com

206-251-6831

Study Officials

• Peter M Milgrom, DDS

  Advantage Silver Dental Arrest, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study personnel except for designated personnel in the data center will be blinded to the participant treatment assignment. In order to maintain blinding, the caries scoring examinations will precede the application of test varnishes at baseline. The staff member applying these varnishes will not perform the caries scoring exams in order to eliminate examiner bias and ensure blinding to treatment assignment. Test drug and comparator are packaged identically.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: March 30, 2017
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: September 10, 2020
• Results First Posted: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

MI (1)