Pharmacokinetics of Advantage Anti-Caries Varnish

Advantage Silver Dental Arrest

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Drug: Anti-caries varnish

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04183231

2016-04-05

Details and patient eligibility

About

The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.

Full description

The study was to characterize serum iodine and fluoride levels over 24 hours after application of a topical dental varnish in healthy adults 23 to 57 years old.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.

Exclusion criteria

• Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions, sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism, hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular thread with heart disease, multi nodular goiter, Graves disease, or autoimmune thyroiditis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Anti-caries varnish

Experimental group

Description:

topical dental varnish, 10% PVP-I, 2.5% NaF, topical application to teeth, 0.4 ml, single application

Treatment:

Drug: Anti-caries varnish