Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age

NCT05670743 | Completed Phase 2 FDA Drug

• 1 other identifier: SDF PK WCGIRB-v1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards.

Conditions

Dental Caries in Children

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Fluoride Cmax

  Maximum serum concentration of fluoride

  21 days

• Silver Cmax

  Maximum serum concentration of silver

  21 days

• Fluoride Tmax

  Time to maximum serum concentration of fluoride

  21 days

• Silver Tmax

  Time to maximum serum concentration of silver

  21 days

• Area Under Curve, Fluoride

  Area under the curve, fluoride

  21 days

• Area Under Curve, Silver

  Area under the curve, silver

  21 days

Study Arms (1)

Silver diamine fluoride

EXPERIMENTAL

Silver diamine fluoride, 38%, topical, single application

Drug: 38% silver diamine fluoride

Interventions

38% silver diamine fluoride DRUG

Topical application of 38% silver diamine fluoride to dental caries lesions

Also known as: Advantage Silver Arrest

Silver diamine fluoride

Eligibility Criteria

• Age: 13 Months - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At least one untreated caries lesion into the dentin
• Live within 10 miles of study site

You may not qualify if:

• oral mucositis
• ulcerative oral lesions
• hypersensitivity to silver or fluoride
• history of treatment with silver diamine fluoride within 3 months

Sponsors & Collaborators

• Advantage Silver Dental Arrest, LLC: lead
• University of Washington: collaborator

Study Sites (1)

Center for Pediatric Dentistry

Seattle, Washington, 98195, United States

Location

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

• Travis Nelson, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model 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.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 4, 2023
• Study Start: March 1, 2023
• Primary Completion: June 10, 2023
• Study Completion: August 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)