Safety Evaluation of Advantage Anti-Caries Varnish

Advantage Dental Services

Status and phase: Completed; Phase 1

Conditions: Dental Caries

Treatments: Drug: Varnish

Study type: Interventional

Funder types: Industry

Identifiers

NCT02645617

PVP-I Varnish

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 36 to 60 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy

Exclusion criteria

• Weight less than 15 kg or hypersensitivity to iodine

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Varnish

Experimental group

Description:

Dental varnish containing povidone iodine and sodium fluoride

Treatment:

Drug: Varnish