Pharmacokinetics of Advantage Arrest

NCT ID: NCT04184271

Last Updated: 2021-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-03-31

Brief Summary

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The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

Detailed Description

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The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

Conditions

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Dental Caries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label exposure--response study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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38% silver diamine fluoride

38% silver diamine fluoride, topical, 1 drop, single application

Group Type EXPERIMENTAL

38% silver diamine fluoride

Intervention Type DRUG

Topical application of SDF to teeth

Interventions

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38% silver diamine fluoride

Topical application of SDF to teeth

Intervention Type DRUG

Other Intervention Names

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Advantage Arrest

Eligibility Criteria

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Inclusion Criteria

* 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications

Exclusion Criteria

* pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Advantage Silver Dental Arrest, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Milgrom, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington Institute of Translational Health Sciences

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. J Am Dent Assoc. 2019 Mar;150(3):186-192. doi: 10.1016/j.adaj.2018.10.018.

Reference Type RESULT
PMID: 30803490 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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2016-11-08

Identifier Type: -

Identifier Source: org_study_id

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