Summary

Eligibility
for people ages 3-13 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
Hellene Ellenikiotis

Description

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).

Details

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 Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point.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

Keywords

Dental Caries child pharmacokinetics silver diamine fluoride Fluorides Advantage Arrest

Eligibility

You can join if…

Open to people ages 3-13

  • Healthy.
  • At least one carious lesion.

You CAN'T join if...

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

Location

  • University of California San Francisco Clinical and Translational Science Institute accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Advantage Silver Dental Arrest, LLC
ID
NCT04186663
Phase
Phase 2
Study Type
Interventional
Last Updated