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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Silver diamine fluoride

Silver diamine fluoride, 38%, topical, single application

Group Type EXPERIMENTAL

38% silver diamine fluoride

Intervention Type DRUG

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

Interventions

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38% silver diamine fluoride

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

Intervention Type DRUG

Other Intervention Names

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Advantage Silver Arrest

Eligibility Criteria

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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

Minimum Eligible Age

13 Months

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes