Nanozymes for Root Canal

NJ
Overseen ByNadasinee Jaruchotiratanasakul, DDS, DScD Candidate
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment using nanozymes (tiny particles that act like enzymes) can outperform the usual sodium hypochlorite in disinfecting and healing teeth during root canal procedures. Researchers aim to determine if these nanozymes can more effectively clean infections and promote long-term healing of teeth. Individuals with a tooth requiring a root canal, showing signs of infection on an X-ray, and who have not previously undergone a root canal on that tooth, may be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment can benefit a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have multiple drug allergies or need antibiotics before dental treatments, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that ferumoxytol nanozymes, a key component of the treatment under study, offer promising safety results. In earlier studies, these nanozymes effectively targeted harmful bacteria in root canal infections without causing side effects, indicating they are well-tolerated by the body. Additionally, the FDA has already approved ferumoxytol for treating anemia, which adds confidence about its safety in other treatments.

When combined with hydrogen peroxide, ferumoxytol nanozymes effectively combat infection-causing bacteria while remaining safe. Studies have demonstrated that this combination achieves results similar to sodium hypochlorite, a common root canal treatment, but with fewer side effects. Overall, the evidence suggests that the nanozyme treatment is safe for human use.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for root canals, which typically involves sodium hypochlorite (a strong disinfectant), the nanozyme treatment uses a novel mixture of Ferumoxytol and hydrogen peroxide. This combination works differently by potentially enhancing the breakdown of bacterial biofilms through a catalytic reaction, offering a new mechanism of action. Researchers are excited because this innovative approach could improve the efficiency and effectiveness of root canal disinfection, potentially reducing treatment times and improving patient outcomes.

What evidence suggests that nanozyme treatment might be an effective treatment for root canal?

This trial will compare the effectiveness of ferumoxytol nanozymes with the standard treatment of sodium hypochlorite for root canal cleaning. Studies have shown that ferumoxytol nanozymes effectively target and reduce stubborn bacterial infections known as biofilms. Biofilms are tough layers of bacteria that can cause long-lasting infections. In research, ferumoxytol used with hydrogen peroxide reduced bacteria by 99.9%, similar to the standard sodium hypochlorite treatment. Additionally, it has fewer side effects, potentially making it safer for patients. These findings suggest that ferumoxytol nanozymes could serve as a strong alternative for cleaning root canals.13467

Are You a Good Fit for This Trial?

This trial is for adults (18+) who need a root canal due to dental abscess or pulp disease, have healthy enough medical history for routine dental care, and whose affected tooth has not had previous root canal treatment. The tooth must be suitable for isolation during the procedure.

Inclusion Criteria

2. Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or a negative response to EPT testing.
I have teeth with single or multiple roots.
I am willing to take part in this study.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endodontic treatment with either Ferumoxytol nanozymes or sodium hypochlorite as irrigants, with microbial sampling conducted during the first and second visits.

2 visits
2 visits (in-person)

Follow-up

Participants are monitored for periapical bone changes and long-term clinical outcomes using radiographs at 6, 12, and 24 months.

2 years
3 visits (in-person) at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nanozyme treatment

Trial Overview

The study compares a new ferumoxytol nanozyme solution with standard sodium hypochlorite (3% NaOCl) as disinfectants during root canal treatment to see which works better at killing germs and promoting healing.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Nanozyme treatmentExperimental Treatment1 Intervention
Group II: Sodium hypochloriteActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

Study Details | NCT07518901 | Nanozymes in Endodontics

This study aims to fill critical knowledge gaps identified in prior clinical findings by optimizing the integration of nanozymes into endodontic ...

Ferumoxytol nanozymes effectively target chronic biofilm ...

Together, these results show that FMX nanozymes are clinically effective against severe chronic biofilm infection with pathogen targeting and ...

Getting to the root of root canals: Nanoparticles offer ...

Penn researchers use iron oxide nanozymes to treat infections during root canals with fewer adverse effects than clinical gold standard ...

Nanozymes for Root Canal · Info for Participants

This Phase 4 medical study run by University of Pennsylvania needs participants to evaluate whether Nanozyme treatment will have tolerable ...

Nanozymes in Endodontics | MedPath

This study aims to fill critical knowledge gaps identified in prior clinical findings by optimizing the integration of nanozymes into endodontic ...

A New Clinical Use of Ferumoxytol Nanoparticles: An ...

Before treatment, patients will be thoroughly informed about the nature, potential risks and alternatives of the study as well as the root canal treatment.

Nanoparticles may be key to treating root canal infections

When combined with hydrogen peroxide (H2O2), nanoparticles can effectively disrupt biofilms due to their small size and antimicrobial properties ...