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NCT04184271 Clinical Trial

Pharmacokinetics of Advantage Arrest

Dental Caries Clinical Trial

Official title:
Pharmacokinetics of Advantage Arrest

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04184271
Other study ID # 2016-11-08
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 1, 2017
Est. completion date March 31, 2019

Study information
Verified date July 2020
Source Advantage Silver Dental Arrest, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date March 31, 2019
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 38% silver diamine fluoride
Topical application of SDF to teeth

Locations
Country Name City State
United States University of Washington Institute of Translational Health Sciences Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
Advantage Silver Dental Arrest, LLC University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Observed Fluoride Urinary Recovery 24 hour fluoride urinary recovery (in mg) baseline to 24 hours
Primary Observed Silver Tmax Observed silver time to maximum serum concentration in hours baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Primary Observed Silver Cmax Observed silver maximum serum concentration in ng/mL baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Primary Observed Silver Baseline-Corrected Cmax Observed silver baseline-corrected maximum serum concentration in ng/mL baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Primary Observed Silver t1/2 Observed silver serum elimination half-life in hours baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
Primary Observed Silver 24 Hour Urinary Concentration Observed silver 24-hour urinary concentration in ng/mL baseline to 24 hours
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