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Completed

NCT Number: NCT03082196

Efficacy Of A PVP-I Fluoride 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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

60 month–84 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pohnpei State Hospital

Kolonia, Pohnpei State, 96941, Micronesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test varnish

Drug

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

Standard varnish

Drug

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

Other names: sodium fluoride varnish

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Child Response to First Treatment

    Time frame: After first treatment visit

    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.

  2. Child Response to Fifth Treatment

    Time frame: After fifth treatment visit

    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.

Sponsors and collaborators

Lead sponsor

Advantage Dental Services, LLC

Industry

Registry information

Official study title

Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2017
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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