NCT02645617

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 30, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 21, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

December 28, 2015

Results QC Date

January 6, 2020

Last Update Submit

January 15, 2020

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Soft Tissue

    Proportion of participants with any oral ulcerations OR inflammatory response

    within 48 hours

Secondary Outcomes (1)

  • Adverse Events

    within 48 hours

Study Arms (1)

Varnish

EXPERIMENTAL

Dental varnish containing povidone iodine and sodium fluoride

Drug: Varnish

Interventions

VarnishDRUG

Topical application to the teeth

Also known as: Advantage Anti-Caries Varnish
Varnish

Eligibility Criteria

Age36 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy

You may not qualify if:

  • Weight less than 15 kg or hypersensitivity to iodine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Regional Clinical Dental Research Center

Seattle, Washington, 98112, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Paint

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Peter Milgrom
Organization
Advantage Silver Dental Arrest, LLC
drmilgrom@silverarrest.com
2062516831

Study Officials

  • Peter Milgrom, DDS

    Advantage Dental

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 5, 2016

Study Start

March 30, 2016

Primary Completion

September 30, 2016

Study Completion

October 20, 2016

Last Updated

January 21, 2020

Results First Posted

January 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)