Trial Outcomes & Findings for Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser in Root Canal Disinfection (NCT NCT05959629)

Results Overview

By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then comparing the two groups.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

All samples will be taken during the first root canal treatment visit. Sample1 before cleaning or shaping the root canal.

Results posted on

2025-10-09

Participant Flow

Allocated to control: n=28, received allocated control =26. 2 when accessed were partially necrotic. Allocated to intervention: n=28, received allocated control =26. 2 had technical issues.

Participant milestones

Participant milestones
Measure	Waterlase Express™, BIOLASE® Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Overall Study STARTED	28	28
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Waterlase Express™, BIOLASE® Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Overall Study partially necrotic/technical issues	2	2

Baseline Characteristics

participants included in the study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Waterlase Express™, BIOLASE® n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=93 Participants	26 Participants n=4 Participants	52 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	45 years STANDARD_DEVIATION 2 • n=93 Participants	44.125 years STANDARD_DEVIATION 2 • n=4 Participants	44.57 years STANDARD_DEVIATION 2 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants • participants included in the study	13 Participants n=4 Participants • participants included in the study	26 Participants n=27 Participants • participants included in the study
Sex: Female, Male Male	13 Participants n=93 Participants • participants included in the study	13 Participants n=4 Participants • participants included in the study	26 Participants n=27 Participants • participants included in the study
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=93 Participants	26 Participants n=4 Participants	52 Participants n=27 Participants
Region of Enrollment United States	26 Participants n=93 Participants	26 Participants n=4 Participants	52 Participants n=27 Participants

PRIMARY outcome

Timeframe: All samples will be taken during the first root canal treatment visit. Sample1 before cleaning or shaping the root canal.

By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then comparing the two groups.

Outcome measures

Outcome measures
Measure	Waterlase Express™, BIOLASE® n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).	8.279923256 Mean CFU Standard Deviation 2.933726699	8.601200494 Mean CFU Standard Deviation 2.99841829

PRIMARY outcome

Timeframe: All samples will be taken during the first root canal treatment visit. Sample2 after cleaning and shaping of the root canal using laser or NaOCl.

By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then comparing the two groups.

Outcome measures

Outcome measures
Measure	Waterlase Express™, BIOLASE® n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).	4.332058015 Mean CFU Standard Deviation 2.154027598	4.373858908 Mean CFU Standard Deviation 2.532760244

PRIMARY outcome

Timeframe: All samples will be taken during the first root canal treatment visit. Sample 3 Upon completion of final routine irrigation protocol.

By measuring change in bacteria colony forming units (CFU) before and after treatment for the experimental group (laser) and the standard of care (NaOCl) group, then completion of final routine irrigation protocol, then comparing the two groups.

Outcome measures

Outcome measures
Measure	Waterlase Express™, BIOLASE® n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol).	2.765533576 Mean CFU Standard Deviation 2.087467581	2.570435011 Mean CFU Standard Deviation 2.413322255

SECONDARY outcome

Timeframe: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the intensity of preoperative pain and postoperative pain at 4-hours post treatment

Following a previous published study done at the Department of Endodontics, University of Pennsylvania. Patients will be asked to rate the intensity of preoperative pain on a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) before receiving root canal treatment. Along with NRS, the Wong-Baker facial grimace scale (images) will also be presented to the patients to help them in scoring the pain. Patients will be asked to rate the intensity of postoperative pain at 4-hours after the procedure. Change = (4 hours score - baseline score)

Outcome measures

Outcome measures
Measure	Waterlase Express™, BIOLASE® n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS) t0	3.28 units on a scale Standard Deviation 3.67	2.38 units on a scale Standard Deviation 3.68
Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS) t4	3.32 units on a scale Standard Deviation 2.67	2.67 units on a scale Standard Deviation 2.66

SECONDARY outcome

Timeframe: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the postoperative pain at 24-hours post treatment

Following a previous published study done at the Department of Endodontics, University of Pennsylvania. Patients will be asked to rate the intensity of preoperative pain on a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) before receiving root canal treatment. Along with NRS, the Wong-Baker facial grimace scale (images) will also be presented to the patients to help them in scoring the pain. Patients will be asked to rate the intensity of postoperative pain at 24-hours after the procedure. Change = (24 hours score - baseline score)

Outcome measures

Outcome measures
Measure	Waterlase Express™, BIOLASE® n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Secondary Outcome: Mean Change From Baseline in Pain Scores at 24 Hours After the Procedure on a Numeric Rating Scale (NRS).	2.16 score on a scale Standard Deviation 2.62	1.13 score on a scale Standard Deviation 1.92

SECONDARY outcome

Timeframe: At the end of the first root canal treatment visit, patients will be given a survey and asked to rate the postoperative pain at 48-hours post treatment

Following a previous published study done at the Department of Endodontics, University of Pennsylvania. Patients will be asked to rate the intensity of preoperative pain on a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain) before receiving root canal treatment. Along with NRS, the Wong-Baker facial grimace scale (images) will also be presented to the patients to help them in scoring the pain. Patients will be asked to rate the intensity of postoperative pain at 48-hours after the procedure. Change = (48 hours score - baseline score)

Outcome measures

Outcome measures
Measure	Waterlase Express™, BIOLASE® n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using Er,Cr:YSGG laser (Waterlase Express™, BIOLASE®), followed by standard of care (NaOCl). Waterlase Express™, BIOLASE®: Er,Cr:YSGG laser 2780nm (Waterlase Express™, BIOLASE®) with 300μm tip (EdgePro #3) will be placed into the mid-root of the canal. The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).	Sodium Hypochlorite n=26 Participants Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). Sodium Hypochlorite: Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Mean Change From Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)	1.44 score on a scale Standard Deviation 0.58	2.20 score on a scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling.