Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:03 AM
NCT ID: NCT06110494
Description: There are no potential risks associated with noninvasive bacteriological sampling. Ferumoxytol with much higher concentrations has been FDA approved and used in medicine as IV to treat iron deficiency anemia. Ferumoxytol used in this study is applied topically and is limited within the root canal system which is devoid of blood supply and was not used systemically. Exclusion criteria was set to exclude participants at risk of developing adverse events reported with systemic applications.
Frequency Threshold: 0
Time Frame: The participation of the participants in this study was within the time necessary for the standard routine single visit root canal therapy. Monitoring of blood pressure and signs and symptoms of hypersensitivity during the next 30 minutes after Ferumoxytol application, during which the remaining treatment sequences of the routine root canal therapy will be carried out. After the procedure was done, the study relied on self reporting by the participant by a routine post-op call the next day.
Study: NCT06110494
Study Brief: A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Iron Oxide Nanoparticles Treatment Ferumoxytol/H2O2 After access preparation with sterile burs and sterile saline irrigation and working length determination as part of routine root canal treatment, and after obtaining a pre-treatment bacteriological samples, 2 mL of a mixture of Ferumoxytol (6mg/mL)/H2O2(3%) was introduced into the canal. Canals were instrumented with 15/0.04, 20/0.04, and 25/0.04 rotary files using 2 mL of treatment solution after each file with a total of 8 mL of solution used and a total contact time of 10 minutes. 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 0 None 0 11 0 11 View
Sodium Hypochlorite (NaOCl) After access preparation with sterile burs and sterile saline irrigation and working length determination as part of routine root canal treatment, and after obtaining a pre-treatment bacteriological samples, 2 mL of 3% NaOCl was introduced into the canal. Canals were instrumented with 15/0.04, 20/0.04, and 25/0.04 rotary files using 2 mL of solution after each file with a total of 8 mL of treatment solution used and a total contact time of 10 minutes. NaOCl: Participants receive a topical treatment through a root canal irrigation needle containing 3% NaOCl for 10 minutes contact time 0 None 0 11 0 11 View
Saline (NaCl) After access preparation with sterile burs and sterile saline irrigation and working length determination as part of routine root canal treatment, and after obtaining a pre-treatment bacteriological samples, 2 mL of 0.89% NaCl was introduced into the canal. Canals were instrumented with 15/0.04, 20/0.04, and 25/0.04 rotary files using 2 mL of treatment solution after each file with a total of 8 mL of solution used and a total contact time of 10 minutes. NaCl: Participants receive a topical treatment through a root canal irrigation needle containing 0.89% NaCl for 10 minutes contact time 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):