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Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model

NCT03678012 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-09-19

No results posted yet for this study

Summary

To evaluate the effects of a clinically approved and commercially available iron oxide formulation Ferumoxytol (Feraheme®) to control cariogenic biofilms and enamel demineralization. This study will be testing topical application of Ferumoxytol extra-orally using a standard in situ biofilm demineralization model.

Conditions

  • Dental Caries

Interventions

DRUG

Ferumoxytol/Hydrogen peroxide

1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.

DRUG

Hydrogen Peroxide

Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.

DRUG

Water

Sham solution (water; negative control). Each subject will use this product during one of three treatment periods in the crossover study design.

Sponsors & Collaborators

Principal Investigators

  • Hyun Koo, Ph.D · University of Pennsylvania

  • Domenick Zero, Ph.D · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2018-08-16
Completion
2018-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678012 on ClinicalTrials.gov