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Safety Evaluation of Advantage Anti-Caries Varnish

NCT ID: NCT02645617

Last Updated: 2020-01-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-30

Study Completion Date

2016-10-20

Brief Summary

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The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.

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Detailed Description

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This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride \[Therametrics Technologies, Inc, Noblesville, IN, USA\]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.

Conditions

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Dental Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Varnish

Dental varnish containing povidone iodine and sodium fluoride

Group Type EXPERIMENTAL

Varnish

Intervention Type DRUG

Topical application to the teeth

Interventions

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Varnish

Topical application to the teeth

Intervention Type DRUG

Other Intervention Names

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Advantage Anti-Caries Varnish

Eligibility Criteria

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Inclusion Criteria

* Healthy

Exclusion Criteria

* Weight less than 15 kg or hypersensitivity to iodine
Minimum Eligible Age

36 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Advantage Dental Services, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Milgrom, DDS

Role: PRINCIPAL_INVESTIGATOR

Advantage Dental

Locations

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University of Washington Regional Clinical Dental Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PVP-I Varnish

Identifier Type: -

Identifier Source: org_study_id

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