Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
Primary Purpose
Dental Caries in Children
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
38% silver diamine fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children focused on measuring pharmacokinetics
Eligibility Criteria
Inclusion Criteria: At least one untreated caries lesion into the dentin Live within 10 miles of study site Exclusion Criteria: oral mucositis ulcerative oral lesions hypersensitivity to silver or fluoride history of treatment with silver diamine fluoride within 3 months
Sites / Locations
- Center for Pediatric Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Silver diamine fluoride
Arm Description
Silver diamine fluoride, 38%, topical, single application
Outcomes
Primary Outcome Measures
Fluoride Cmax
Maximum serum concentration of fluoride
Silver Cmax
Maximum serum concentration of silver
Fluoride Tmax
Time to maximum serum concentration of fluoride
Silver Tmax
Time to maximum serum concentration of silver
Area Under Curve, Fluoride
Area under the curve, fluoride
Area Under Curve, Silver
Area under the curve, silver
Secondary Outcome Measures
Full Information
NCT ID
NCT05670743
First Posted
January 2, 2023
Last Updated
July 19, 2023
Sponsor
Advantage Silver Dental Arrest, LLC
Collaborators
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT05670743
Brief Title
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
Official Title
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advantage Silver Dental Arrest, LLC
Collaborators
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The FDA requested additional data to evaluate the pharmacokinetics of silver diamine fluoride (SDF, Advantage Arrest) in children 13 months to 13 years old. The first request is for children under 36 months of age to be included in a study. The second request is for serum silver concentration be evaluated for a longer duration post-application to better estimate the half-life of silver and return of serum silver to baseline levels in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silver diamine fluoride
Arm Type
Experimental
Arm Description
Silver diamine fluoride, 38%, topical, single application
Intervention Type
Drug
Intervention Name(s)
38% silver diamine fluoride
Other Intervention Name(s)
Advantage Silver Arrest
Intervention Description
Topical application of 38% silver diamine fluoride to dental caries lesions
Primary Outcome Measure Information:
Title
Fluoride Cmax
Description
Maximum serum concentration of fluoride
Time Frame
21 days
Title
Silver Cmax
Description
Maximum serum concentration of silver
Time Frame
21 days
Title
Fluoride Tmax
Description
Time to maximum serum concentration of fluoride
Time Frame
21 days
Title
Silver Tmax
Description
Time to maximum serum concentration of silver
Time Frame
21 days
Title
Area Under Curve, Fluoride
Description
Area under the curve, fluoride
Time Frame
21 days
Title
Area Under Curve, Silver
Description
Area under the curve, silver
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Months
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one untreated caries lesion into the dentin
Live within 10 miles of study site
Exclusion Criteria:
oral mucositis
ulcerative oral lesions
hypersensitivity to silver or fluoride
history of treatment with silver diamine fluoride within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Travis Nelson, DDS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Pediatric Dentistry
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
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