drugset / Trial / NCT06110494

A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment

NCT06110494

Phase 4 Completed 44 enrolled University of Pennsylvania
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this observational is study is to develop a protocol for root canal biofilms disinfection using a clinically approved and commercially available iron oxide nanoparticle formulation Ferumoxytol/H2O2 treatments. This protocol will be testing local single topical application of Ferumoxytol within the root canal system in patients going through routine root canal treatment, evaluate its potential as anti-biofilm treatment and compare it to the clinical gold standard disinfecting solution sodium hypochlorite (positive control) and saline (negative control).

Timeline

Start
2020-07-13
Primary completion
2022-03-10
Completion
2022-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferumoxytol Diagnostic / imaging agent 6 mg/ml Topical
Subject Hydrogen Peroxide Small molecule 3 % Topical
Comparator Sodium Hypochlorite Unknown 3 % Topical