Efficacy Of A PVP-I Fluoride Varnish

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Test varnish; Drug: Standard varnish

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 Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 2

Contacts and Locations

Study Locations

• Federated States of Micronesia
  • Kolonia, Federated States of Micronesia, 96941
    • Pohnpei State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test varnish; Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .	Drug: Test varnish; Topical application of test varnish to the teeth 4 times per year.
Active Comparator: Standard varnish; 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; Topical application of test varnish to the teeth 4 times per year; Other Names: sodium fluoride varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After fifth treatment visit

Collaborators and Investigators

• Sponsor: Advantage Dental Services, LLC
• Investigators: Study Chair: Peter M Milgrom, DDS, Advantage Silver Dental Arrest, LLC

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): May 7, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: sodium fluoride; povidone iodine; varnish
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: 2016-12-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No