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Trial record 91 of 1201 for:    tooth decay

Efficacy Of A PVP-I Fluoride Varnish

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03082196
Recruitment Status : Active, not recruiting
First Posted : March 17, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Advantage Dental Services, LLC

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 (d2mfs) at 24- months post baseline.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Test varnish Drug: Standard varnish Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Prevention
Official Title: Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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 Name: sodium fluoride varnish




Primary Outcome Measures :
  1. Dental caries [ Time Frame: 24 months ]

    The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at two years post baseline, but the incremental dental caries at one year will also be compared between the two interventions.

    The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at two years post baseline, but the incremental dental caries at one year will also be compared between the two interventions.

    Surface-level primary molar caries increment (d2-3mfs/DMFS)



Secondary Outcome Measures :
  1. Child response to treatment [ Time Frame: After 1st and 4th treatment visit ]
    Facial Images Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Months to 84 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082196


Locations
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Federated States of Micronesia
Pohnpei State Hospital
Kolonia, Federated States of Micronesia, 96941
Sponsors and Collaborators
Advantage Dental Services, LLC
Investigators
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Study Chair: Peter M Milgrom, DDS Advantage Silver Dental Arrest, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Advantage Dental Services, LLC
ClinicalTrials.gov Identifier: NCT03082196     History of Changes
Other Study ID Numbers: 2016-12-02
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Advantage Dental Services, LLC:
sodium fluoride
povidone iodine
varnish

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Fluorides, Topical
Povidone
Povidone-Iodine
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents