Pharmacokinetics of Advantage Arrest in Children

Advantage Silver Dental Arrest

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Drug: Silver Diamine Fluoride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04186663

2019-06-23

Details and patient eligibility

About

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

Full description

This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest. This is an open label exposure-response study with up to 50 healthy children ages 3-13 years of age. Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point. A minimum of 3 subjects per time point at 2,4,6,24,48,96 and 168 hours. Serum samples will be analyzed for F and Ag.

Enrollment: 59 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy.
• At least one carious lesion.

Exclusion criteria

• Oral mucositis
• Any ulcerative lesions
• Hypersensitivity to silver
• Hypersensitivity to fluoride.
• SDF treatment within 3 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Advantage Arrest

Experimental group

Description:

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

Treatment:

Drug: Silver Diamine Fluoride