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Efficacy Of A PVP-I Fluoride Varnish

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 2
Locations
Federated States of Micronesia
Study Type
Interventional
Intervention
Test varnish
Standard varnish
Sponsored by
Advantage Dental Services, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring sodium fluoride, povidone iodine, varnish

Eligibility Criteria

60 Months - 84 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pohnpei State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test varnish

Standard varnish

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 13, 2017
Last Updated
September 9, 2020
Sponsor
Advantage Dental Services, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03082196
Brief Title
Efficacy Of A PVP-I Fluoride Varnish
Official Title
Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advantage Dental Services, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
sodium fluoride, povidone iodine, varnish

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test varnish
Arm Type
Experimental
Arm Description
Advantage Anti-Caries Varnish. The active ingredients are Povidone Iodine and Sodium Fluoride .
Arm Title
Standard varnish
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Test varnish
Intervention Description
Topical application of test varnish to the teeth 4 times per year.
Intervention Type
Drug
Intervention Name(s)
Standard varnish
Other Intervention Name(s)
sodium fluoride varnish
Intervention Description
Topical application of test varnish to the teeth 4 times per year
Primary Outcome Measure Information:
Title
Dental Caries for Primary Molars Sound at Baseline
Description
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.
Time Frame
24 months
Title
Dental Caries for All Primary Teeth Sound at Baseline
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Child Response to First Treatment
Description
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.
Time Frame
After first treatment visit
Title
Child Response to Fifth Treatment
Description
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.
Time Frame
After fifth treatment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Months
Maximum Age & Unit of Time
84 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Milgrom, DDS
Organizational Affiliation
Advantage Silver Dental Arrest, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Pohnpei State Hospital
City
Kolonia
ZIP/Postal Code
96941
Country
Federated States of Micronesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32437626
Citation
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.
Results Reference
derived
PubMed Identifier
28667230
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy Of A PVP-I Fluoride Varnish

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