Pharmacokinetics of Advantage Arrest in Children

NCT ID: NCT04186663

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-03-31

Brief Summary

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).

Detailed 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 Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point.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.

Conditions

Dental Caries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Advantage Arrest

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

Group Type: EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type: DRUG

38% aqueous silver diamine fluoride \[Ag(NH3)\]2F, CAS RN 33040-28-7

Interventions

Silver Diamine Fluoride

38% aqueous silver diamine fluoride \[Ag(NH3)\]2F, CAS RN 33040-28-7

Intervention Type: DRUG

Other Intervention Names

Advantage Arrest

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Advantage Silver Dental Arrest, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hellene Ellenikiotis, DDS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco Clinical and Translational Science Institute

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-06-23

Identifier Type: -

Identifier Source: org_study_id