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Pharmacokinetics of Advantage Arrest in Children

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ClinicalTrials.gov Identifier: NCT04186663
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Advantage Silver Dental Arrest, LLC

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Silver Diamine Fluoride Phase 2

Detailed 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. 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 Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point.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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label exposure--response study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Advantage Arrest in Children
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arms and Interventions
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Arm Intervention/treatment
Experimental: Advantage Arrest
38% silver diamine fluoride, topical, 1 drop, single application
 Drug: Silver Diamine Fluoride
38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7
Other Name: Advantage Arrest


Outcome Measures
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Primary Outcome Measures :
  1. Serum F [ Time Frame: Baseline to 168 hours ]
    serum fluoride concentration

  2. Serum Ag [ Time Frame: Baseline to 168 hours ]
    serum silver concentration


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy.
  • At least one carious lesion.

Exclusion Criteria:

  • Oral mucositis
  • Any ulcerative lesions
  • Hypersensitivity to silver
  • Hypersensitivity to fluoride.
  • SDF treatment within 3 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186663


Contacts
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Contact: Hellene M Ellenikiotis, DDS 2062516831 hellene.ellenikiotis@ucsf.edu
Contact: Hellene Ellenikiotis, DDS 4083130166 hellene.ellenikiotis@ucsf.edu

Locations
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United States, California
University of California San Francisco Clinical and Translational Science Institute Recruiting
San Francisco, California, United States, 94158
Contact: Hellene Ellenikiotis, DDS    408-313-0166    hellene.ellenikiotis@ucsf.edu   
Contact: Hellene Ellenikiotis    4083130166    hellene.ellenikiotis@ucsf.edu   
Principal Investigator: Hellene Ellenikiotis, DDS         
Sub-Investigator: Pinelopi Xenoudi, DDS         
Sub-Investigator: Yvonne Lin, PhD         
Sub-Investigator: Peter Milgrom, DDS         
Sponsors and Collaborators
Advantage Silver Dental Arrest, LLC
University of California, San Francisco
Investigators
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Principal Investigator: Hellene Ellenikiotis, DDS University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Advantage Silver Dental Arrest, LLC:
Study Protocol and Statistical Analysis Plan  [PDF] June 23, 2019

More Information
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Responsible Party: Advantage Silver Dental Arrest, LLC
ClinicalTrials.gov Identifier: NCT04186663    
Other Study ID Numbers: 2019-06-23
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Advantage Silver Dental Arrest, LLC:
child
pharmacokinetics
silver diamine fluoride
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
 Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs