Trial Outcomes & Findings for A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment (NCT NCT06110494)
NCT ID: NCT06110494
Last Updated: 2024-08-28
Results Overview
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 sample) between the three disinfection protocols
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
baseline (pretreatment) and after 10 minutes of treatment (post treatment)
Results posted on
2024-08-28
Participant Flow
Patients presenting to the Department of Endodontics, School of Dental Medicine, University of Pennsylvania for evaluation and routine endodontic treatment of infected, necrotic teeth with chronic apical periodontitis were asked if they would like to take part in the study and volunteer to participate.
Forty-four (44) patients presenting to the endodontic with an initial diagnosis of pulp necrosis were assessed for eligibility. Seven (7) patients were initially excluded during the eligibility assessment (not meeting inclusion criteria (n=4);declined to participate (n=3). five patients were part of a pilot to test different bacterial sampling methods prior to the experimental phase
Unit of analysis: roots
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
11 11
|
11 11
|
10 10
|
|
Overall Study
COMPLETED
|
8 8
|
10 10
|
9 9
|
|
Overall Study
NOT COMPLETED
|
3 3
|
1 1
|
1 1
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
|
Overall Study
Dixon's test for outlier analysis
|
1
|
1
|
0
|
Baseline Characteristics
Sex of the participants was not collected as baseline information during the study
Baseline characteristics by cohort
| Measure |
Iron Oxide Nanoparticles Treatment Ferumoxytol/H2O2
n=11 Participants
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
|
Sodium Hypochlorite (NaOCl)
n=11 Participants
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
|
Saline (NaCl)
n=10 Participants
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
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
32 participants
n=32 Participants
|
|
Age, Categorical
<=18 years
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
32 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
0 Participants
Sex of the participants was not collected as baseline information during the study
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
0 Participants
Sex of the participants was not collected as baseline information during the study
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: baseline (pretreatment) and after 10 minutes of treatment (post treatment)Population: The antimicrobial effectiveness of Fer/H2O2 was evaluated by calculating the CFU log reduction of the viable microbial counts between pretreatment sample S1 and the post treatment sample S2 and compare it with the CFU log reduction of NaOCL and NaCl
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 sample) between the three disinfection protocols
Outcome measures
| Measure |
Iron Oxide Nanoparticles Treatment Ferumoxytol/H2O2
n=7 Roots
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
|
Sodium Hypochlorite (NaOCl)
n=10 Roots
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
|
Saline (NaCl)
n=9 Roots
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
|
|---|---|---|---|
|
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 CFU log reduction
Interval 0.0000559 to 0.00189
|
0.0001056 CFU log reduction
Interval 0.0000146 to 0.2104
|
0.01196 CFU log reduction
Interval 0.002769 to 0.05574
|
SECONDARY outcome
Timeframe: the baseline of this measurement starts right after treatment with either experimental, negative or positive control agent (S2). This measurement ends after irrigating the canals with NaOCl and irritant activation for 3 minutes.Population: The antimicrobial effectiveness of supplementary irrigation was evaluated by calculating the CFU log reduction of the viable microbial counts between post treatment sample S2 and the post supplementary irrigation sample S3 and compare it with the CFU log reduction of NaOCL and NaCl (positive and negative controls)
All groups received an additional irrigation step with NaOCl with passive ultrasonic activation. An additional step was included for all the test groups to evaluate if further irrigation after (S2) will lead to more reduction of bacterial counts inside the root canal system. This could inform future experiments evaluating the possibility of synergistic antimicrobial effects for the sequential ferumoxytol and NaOCl treatment.
Outcome measures
| Measure |
Iron Oxide Nanoparticles Treatment Ferumoxytol/H2O2
n=8 roots
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
|
Sodium Hypochlorite (NaOCl)
n=9 roots
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
|
Saline (NaCl)
n=9 roots
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
|
|---|---|---|---|
|
The Effect of Additional (Supplementary) Irrigation and Adjunctive Irrigant (NaOCl) Activation Using Passive Ultrasonic Activation After Irrigation With Experimental and Control Irrigants.
|
1.000 CFU log reduction
Interval 0.4345 to 2.453
|
1 CFU log reduction
Interval 0.1472 to 6.0
|
0.1360 CFU log reduction
Interval 0.0271 to 8.4
|
SECONDARY outcome
Timeframe: This measure starts at baseline (pretreatment) (S1). This measure ends after 10 minutes of treatment with either experimental, positive or negative control irrigants and additional 3 minutes of supplementary irrigation (S3)Population: The overall antimicrobial effectiveness of antimicrobial irrigation was evaluated by calculating the CFU log reduction of the viable microbial counts between baseline pretreatment sample (S1) and the post supplementary irrigation sample (S3). The CFU log reduction was compared between the groups (experimental and controls)
All groups received treated with either Experimental (ferumoxytol), NaOCl (positive control) or Saline (NaCl, negative control). Followed by supplementary irrigation and activation. This could inform future experiments evaluating the possibility of synergistic antimicrobial effects for the sequential ferumoxytol and NaOCl treatment.
Outcome measures
| Measure |
Iron Oxide Nanoparticles Treatment Ferumoxytol/H2O2
n=7 roots
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
|
Sodium Hypochlorite (NaOCl)
n=9 roots
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
|
Saline (NaCl)
n=9 roots
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
|
|---|---|---|---|
|
The Overall Effect of Antimicrobial Irrigation of Infected Root Canals Using Experimental and Control Irrigants, in Addition to Supplementary Irrigant (NaOCl) Activation.
|
0.0002360 CFU log reduction
Interval 0.000158 to 0.00189
|
0.0001590 CFU log reduction
Interval 0.00004078 to 0.05725
|
0.001630 CFU log reduction
Interval 0.000266 to 0.0538
|
Adverse Events
Iron Oxide Nanoparticles Treatment Ferumoxytol/H2O2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Hypochlorite (NaOCl)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline (NaCl)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bekir Karabucak Chair of the Department of Endodontics
University of Pennsylvania
Phone: 215-898-4927
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place