At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment
In Brief
A Phase 4 clinical trial evaluating Iron oxide nanoparticles treatment Ferumoxytol/H2O2, NaOCl, and 2 other interventions for Apical Periodontitis and Pulp Disease, Dental. Completed, enrolled 44 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Participants receive a topical treatment through a root canal irrigation needle containing A mixture of 6mg/mL Ferumoxytol nanoparticles solution mixed with 3% H2O2 for 10 minutes contact time
Participants receive a topical treatment through a root canal irrigation needle containing 3% NaOCl for 10 minutes contact time
Participants receive a topical treatment through a root canal irrigation needle containing 0.89% NaCl for 10 minutes contact time
All canals in all groups were irrigated with 2 mL of 3% NaOCl, followed by ultrasonic irrigant activation for 30s twice. seconds. This step was repeated once again making the total activation time 1 min and the total contact time of the irrigant 3 min. Upon completion of irrigation, a third bacterial sample (S3) was taken following the deactivation, washing, drying, and sampling steps as described previously