Pharmacokinetics of Advantage Arrest

Advantage Silver Dental Arrest

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Drug: 38% silver diamine fluoride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04184271

2016-11-08

Details and patient eligibility

About

The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

Full description

The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications

Exclusion criteria

• pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

38% silver diamine fluoride

Experimental group

Description:

38% silver diamine fluoride, topical, 1 drop, single application

Treatment:

Drug: 38% silver diamine fluoride