Pharmacokinetics of Advantage Arrest in Healthy Children... | NCT05670743

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

NCT05670743

Sponsor

Advantage Silver Dental Arrest, LLC

Status

Completed

Last Update Posted

Aug 6, 2024Actual

Enrollment

23Actual

Phase

Phase 2

Conditions

Dental Caries in Children

Interventions

38% silver diamine fluoride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Jun 10, 2023Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Jan 2, 2023

First Submission Date that Met QC Criteria

Jan 2, 2023

First Posted Date

Jan 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2024

Last Update Posted Date

Aug 6, 2024Actual

Name	Class
University of Washington	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silver diamine fluoride	Experimental	Silver diamine fluoride, 38%, topical, single application	Drug: 38% silver diamine fluoride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
38% silver diamine fluoride	Drug	Topical application of 38% silver diamine fluoride to dental caries lesions	Silver diamine fluoride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Months

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Travis Nelson, DDS	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Pediatric Dentistry		Seattle	Washington	98195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024633	silver diamine fluoride

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.