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Safety Evaluation of Advantage Anti-Caries Varnish

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
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

Eligibility Criteria

36 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Weight less than 15 kg or hypersensitivity to iodine

Sites / Locations

  • University of Washington Regional Clinical Dental Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Varnish

Arm Description

Dental varnish containing povidone iodine and sodium fluoride

Outcomes

Primary Outcome Measures

Soft Tissue
Proportion of participants with any oral ulcerations OR inflammatory response

Secondary Outcome Measures

Adverse Events
Proportion of participants with any emergency medical care OR report of nausea OR not eating OR vomiting OR difficulty swallowing OR swelling around the mouth OR itchiness around the mouth OR hives OR rash OR stomach ache OR diarrhea

Full Information

First Posted
December 28, 2015
Last Updated
January 15, 2020
Sponsor
Advantage Dental Services, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02645617
Brief Title
Safety Evaluation of Advantage Anti-Caries Varnish
Official Title
Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2016 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
October 20, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varnish
Arm Type
Experimental
Arm Description
Dental varnish containing povidone iodine and sodium fluoride
Intervention Type
Drug
Intervention Name(s)
Varnish
Other Intervention Name(s)
Advantage Anti-Caries Varnish
Intervention Description
Topical application to the teeth
Primary Outcome Measure Information:
Title
Soft Tissue
Description
Proportion of participants with any oral ulcerations OR inflammatory response
Time Frame
within 48 hours
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Proportion of participants with any emergency medical care OR report of nausea OR not eating OR vomiting OR difficulty swallowing OR swelling around the mouth OR itchiness around the mouth OR hives OR rash OR stomach ache OR diarrhea
Time Frame
within 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Exclusion Criteria: Weight less than 15 kg or hypersensitivity to iodine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Milgrom, DDS
Organizational Affiliation
Advantage Dental
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Regional Clinical Dental Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety Evaluation of Advantage Anti-Caries Varnish

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