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NCT05670743
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
Conditions: Dental Caries in Children
Sex: All
Ages: 13 Months – 13 Years
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 30
Sponsor: Advantage Silver Dental Arrest, LLC
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:At least one untreated caries lesion into the dentinLive within 10 miles of study siteExclusion Criteria:oral mucositisulcerative oral lesionshypersensitivity to silver or fluoridehistory of treatment with silver diamine fluoride within 3 months
Source: ClinicalTrials.gov (NCT05670743). StuddyBuddy aggregates publicly available trial information.