Phase 4
Completed N=32
A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment
chronic apical periodontitis · Pulp Disease, Dental
Source: ClinicalTrials.gov NCT06110494 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: The Primary Outcome Parameter Will be the Difference in Bacterial Reduction Between the Experimental and Control Disinfection Groups Group (Ferumoxytol) and Comparison Groups (Positive and Negative Controls). — 0.0002300; 0.0001056; 0.01196 CFU log reduction — p=0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Parameter Will be the Difference in Bacterial Reduction Between the Experimental and Control Disinfection Groups Group (Ferumoxytol) and Comparison Groups (Positive and Negative Controls). |
0.0002300; 0.0001056; 0.01196 | 0.05 |
| SECONDARY The Effect of Additional (Supplementary) Irrigation and Adjunctive Irrigant (NaOCl) Activation Using Passive Ultrasonic Activation After Irrigation With Experimental and Control Irrigants. |
1.000; 1; 0.1360 | — |
| SECONDARY The Overall Effect of Antimicrobial Irrigation of Infected Root Canals Using Experimental and Control Irrigants, in Addition to Supplementary Irrigant (NaOCl) Activation. |
0.0002360; 0.0001590; 0.001630 | — |
Eligibility Criteria
Inclusion Criteria
- Patients to welling to participate in the study.
- Patients are 18 years or above.
- Non-contributory medical history (Patient can be seen for regular dental appointment in PDM; ASA classes I and II).
- Tooth requiring root canal treatment with radiographic presence of periapical radiolucency and responding to thermal sensitivity testing negatively (difluordichlormethane at 50 °C) (Endo-Ice, Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) and Negatively to EPT testing.
- Tooth with adequate remaining tooth structure for proper isolation with rubber dam.
- No history of previous endodontic treatment on the tooth.
- Teeth with single canal and single and roots with single canals in multirooted teeth.
Exclusion Criteria
- Self-reported Pregnancy.
- Patients requiring antibiotic premedication prior to dental treatment.
- Patients with multiple drug allergies.
- Patients with known hypersensitivity to Ferumoxytol nanoparticles or any iron products.
- Patients who are scheduled for MRI for the head region within three months after Fer nanoparticles application.
- Periodontal changes (pockets 3 mm, mobility Grade I or gingival edema).
- Radiographic presence of resorptive processes.
- Cracked and fractured teeth.
- if one of the inclusion criteria is not met
Data sourced from ClinicalTrials.gov (NCT06110494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.