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NCT06110494 · ClinicalTrials.gov registry record · Phase 4

A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment

A Phase 4 study of Apical Periodontitis and Pulp Disease, Dental, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 4
Development phase
44
Enrollment target
1
Study location

NCT06110494: Completed Phase 4 study of Apical Periodontitis and Pulp Disease, Dental, sponsored by University of Pennsylvania.

NCT06110494 is a Phase 4 study of Apical Periodontitis and Pulp Disease, Dental that has completed, run by University of Pennsylvania. The registered enrollment target is 44 participants, below the 67-participant average among 4 other Apical Periodontitis trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06110494, a Phase 4 study of Apical Periodontitis and Pulp Disease, Dental, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 4
Development phase
44 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

This study is designed to evaluate the antibacterial efficacy of Ferumoxytol/H2O2 and to compare it to the gold standard disinfection solution (NaOCl) and negative control solution (NaCl). The outcome will be evaluated by taking bacterial samples from the root canals during routine root canal treatment before and after applying different disinfection protocols. The disinfection efficacy was calculated by comparing the difference in microbial CFU reduction (post treatment sample/pretreatment samp

Conditions Studied

Apical Periodontitis Pulp Disease, Dental

Interventions

  • DRUG Iron oxide nanoparticles treatment Ferumoxytol/H2O2
  • DRUG NaOCl
  • DRUG NaCl
  • DRUG supplementary irrigation

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2020-07-13
Est. Completion 2022-03-10
Phase Phase 4
University of Pennsylvania

1,423 total trials

What the finished NCT06110494 record still lists

NCT06110494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 67-participant average among 4 other Apical Periodontitis trials with a reported enrollment target (34% lower).

The record links to 2 conditions, with Apical Periodontitis appearing as the primary indexed condition, and to 4 interventions - of which Iron oxide nanoparticles treatment Ferumoxytol/H2O2 is the first listed.

NCT06110494 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06110494 about?

NCT06110494 is a clinical study titled "A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment". 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 ...

What is the current status of trial NCT06110494?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2020-07-13. Estimated completion is 2022-03-10.

What conditions does trial NCT06110494 study?

This clinical trial studies the following conditions: Apical Periodontitis, Pulp Disease, Dental.

What interventions are being tested in trial NCT06110494?

The interventions under investigation include: Iron oxide nanoparticles treatment Ferumoxytol/H2O2 (DRUG), NaOCl (DRUG), NaCl (DRUG), supplementary irrigation (DRUG).

Who is sponsoring clinical trial NCT06110494?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06110494 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT06110494, the US trial registry maintained by the National Library of Medicine. NCT06110494 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.