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A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment

NCT06110494 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-08-28

Study results available
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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).

Conditions

  • Apical Periodontitis
  • Pulp Disease, Dental

Interventions

DRUG

Iron oxide nanoparticles treatment Ferumoxytol/H2O2

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

DRUG

NaOCl

Participants receive a topical treatment through a root canal irrigation needle containing 3% NaOCl for 10 minutes contact time

DRUG

NaCl

Participants receive a topical treatment through a root canal irrigation needle containing 0.89% NaCl for 10 minutes contact time

DRUG

supplementary irrigation

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

Sponsors & Collaborators

Principal Investigators

  • Bekir Karabucak, DMD, MS · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-03-10
Completion
2022-03-10
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 NCT06110494 on ClinicalTrials.gov