Safety Evaluation of Advantage Anti-Caries Varnish

• Sponsor: Advantage Dental Services, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02645617
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Drug: Varnish	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
• Actual Study Start Date: Mar 30, 2016
• Actual Primary Completion Date: Sep 30, 2016
• Actual Study Completion Date: Oct 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Varnish Dental varnish containing povidone iodine and sodium fluoride	Drug: Varnish; Topical application to the teeth; Other Names: Advantage Anti-Caries Varnish

Outcome Measures

Primary Outcome Measures

1. Soft Tissue [within 48 hours]

   Proportion of participants with any oral ulcerations OR inflammatory response

Secondary Outcome Measures

1. Adverse Events [within 48 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 36 Months to 60 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Weight less than 15 kg or hypersensitivity to iodine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington Regional Clinical Dental Research Center	Seattle	Washington	United States	98112

Sponsors and Collaborators

• Advantage Dental Services, LLC

Investigators

• Principal Investigator: Peter Milgrom, DDS, Advantage Dental

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Advantage Dental Services, LLC
• ClinicalTrials.gov Identifier: NCT02645617
• Other Study ID Numbers: PVP-I Varnish
• First Posted: Jan 5, 2016
• Last Update Posted: Jan 21, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Dental Caries; Imidacloprid

Study Results

Participant Flow

Arm/Group Title	Varnish
Arm/Group Description	Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Varnish
Arm/Group Description	Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Overall Participants	12
Age (Count of Participants)
<=18 years	12 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 33.3%
Not Hispanic or Latino	8 66.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 16.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 8.3%
White	5 41.7%
More than one race	2 16.7%
Unknown or Not Reported	2 16.7%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Soft Tissue
Description	Proportion of participants with any oral ulcerations OR inflammatory response
Time Frame	within 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varnish
Arm/Group Description	Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Measure Participants	12
Count of Participants [Participants]	0 0%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Varnish
Arm/Group Description	Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
Measure Participants	12
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	48 hours
Adverse Event Reporting Description	Intraoral erythema
Arm/Group Title	Varnish
Arm/Group Description	Dental varnish containing povidone iodine and sodium fluoride Varnish: Topical application to the teeth
All Cause Mortality
	Varnish
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Varnish
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Varnish
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.