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Pharmacokinetics of Advantage Anti-Caries Varnish

A

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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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