An interventional study of Waterlase Express™, BIOLASE® and Sodium Hypochlorite in Endodontic Disease and Root Canal Infection, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
The purpose of this study is to develop a protocol for biofilms disinfection with a FDA cleared, clinically approved and commercially available Er,Cr:YSGG laser treatments. This protocol will be testing local single topical application of Lasers within the canal system in patients going through routine endodontic treatment, evaluate its potential as anti-biofilm treatment and compare it to other currently used antibacterial protocols.
After being informed about the study and its potential risk, for all patients giving written informed consent we will screen potential participants by inclusion and exclusion criteria; clinical assessment, obtain radiographs, medical history/medications and documents to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a 1:1 ratio to Group 1: Standard of care irrigation protocol "Sodium Hypochlorite (NaOCl)", Group 2: Er,Cr:YSGG laser + standard of care irrigation protocol (NaOCl).
125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.
This study's enrollment of 56 is above the median of 50 across 103 interventional studies indexed under Dental Pulp Diseases.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria:
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).
Device: Waterlase Express™, BIOLASE®
Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl).
Other: Sodium Hypochlorite
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 The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).
Also known as: Er,Cr:YSGG laser, Waterlase Express™
Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Also known as: NaOCl
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used 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 comparing the two groups.
Time frame: All samples will be taken during the first root canal treatment visit. Sample1 before cleaning or shaping the root canal.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used 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 comparing the two groups.
Time frame: 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.
The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used 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.
Time frame: All samples will be taken during the first root canal treatment visit. Sample 3 Upon completion of final routine irrigation protocol.
Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS)
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)
Time frame: 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
Secondary Outcome: Mean Change From Baseline in Pain Scores at 24 Hours After the Procedure on a Numeric Rating Scale (NRS).
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)
Time frame: 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
Mean Change From Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)
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)
Time frame: 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
Periapical Bone Changes From Baseline in Periapical Radiographs at 6 Months Follow Up
Periapical radiographs will be taken at baseline (preoperative) then at 6 months follow up post root canal filling Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings: 1. Normal periapical structures. 2. Small changes in the bone structure. 3. Change in the bone structure with mineral loss. 4. Periodontitis with a well-defined radiolucent area. 5. Severe periodontitis with exacerbating features. Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
Time frame: Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling.
Periapical Bone Changes From Baseline in Periapical Radiographs at 1 Year Follow Up
Periapical radiographs will be taken at baseline (preoperative) then at 1 year follow up post root canal filling Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings: 1. Normal periapical structures. 2. Small changes in the bone structure. 3. Change in the bone structure with mineral loss. 4. Periodontitis with a well-defined radiolucent area. 5. Severe periodontitis with exacerbating features. Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
Time frame: Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling.
Periapical Bone Changes From Baseline in Periapical Radiographs at 2 Years Follow Up
Periapical radiographs will be taken at baseline (preoperative) then at 2 years follow up post root canal filling Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings: 1. Normal periapical structures. 2. Small changes in the bone structure. 3. Change in the bone structure with mineral loss. 4. Periodontitis with a well-defined radiolucent area. 5. Severe periodontitis with exacerbating features. Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
Time frame: Periapical bone changes measured at baseline and 2 years follow up (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 6 Months Follow Up
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 6 months follow up. Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts. Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
Time frame: Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 1 Year Follow Up
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 1 year follow up. Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts. Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
Time frame: Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling.
Presence of Clinical Signs or Symptoms at 2 Years Follow Up
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 2 years follow up. Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts. Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
Time frame: Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling.
Tooth Survival at 6 Months Follow Up
Tooth survival is defined as the presence of the tooth inside the mouth. Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
Time frame: Measured at 6 months (± 7 days) post root canal filling.
Tooth Survival at 1 Year Follow Up
Tooth survival is defined as the presence of the tooth inside the mouth. Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
Time frame: Measured at 1 year (± 7 days) post root canal filling.
Tooth Survival at 2 Years Follow Up
Tooth survival is defined as the presence of the tooth inside the mouth. Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
Time frame: Measured at 2 years (± 7 days) post root canal filling.
| Milestone | Waterlase Express™, BIOLASE® | Sodium Hypochlorite |
|---|---|---|
| Started | 28 | 28 |
| Completed | 26 | 26 |
| Not completed | 2 | 2 |
| Withdrew: Partially necrotic/technical issues | 2 | 2 |
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.
| Mean CFU | Waterlase Express™, BIOLASE® | Sodium Hypochlorite |
|---|---|---|
| The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). | 8.279923256 ± 2.933726699 | 8.601200494 ± 2.99841829 |
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.
| Mean CFU | Waterlase Express™, BIOLASE® | Sodium Hypochlorite |
|---|---|---|
| The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). | 4.332058015 ± 2.154027598 | 4.373858908 ± 2.532760244 |
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.
| Mean CFU | Waterlase Express™, BIOLASE® | Sodium Hypochlorite |
|---|---|---|
| The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). | 2.765533576 ± 2.087467581 | 2.570435011 ± 2.413322255 |
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)
| units on a scale | Waterlase Express™, BIOLASE® | Sodium Hypochlorite |
|---|---|---|
| t0 | 3.28 ± 3.67 | 2.38 ± 3.68 |
| t4 | 3.32 ± 2.67 | 2.67 ± 2.66 |
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)
| score on a scale | Waterlase Express™, BIOLASE® | Sodium Hypochlorite |
|---|---|---|
| Secondary Outcome: Mean Change From Baseline in Pain Scores at 24 Hours After the Procedure on a Numeric Rating Scale (NRS). | 2.16 ± 2.62 | 1.13 ± 1.92 |
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)
| score on a scale | Waterlase Express™, BIOLASE® | Sodium Hypochlorite |
|---|---|---|
| Mean Change From Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS) | 1.44 ± 0.58 | 2.20 ± 1.50 |
Periapical radiographs will be taken at baseline (preoperative) then at 6 months follow up post root canal filling Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings: 1. Normal periapical structures. 2. Small changes in the bone structure. 3. Change in the bone structure with mineral loss. 4. Periodontitis with a well-defined radiolucent area. 5. Severe periodontitis with exacerbating features. Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
No measurements were reported for this outcome.
Periapical radiographs will be taken at baseline (preoperative) then at 1 year follow up post root canal filling Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings: 1. Normal periapical structures. 2. Small changes in the bone structure. 3. Change in the bone structure with mineral loss. 4. Periodontitis with a well-defined radiolucent area. 5. Severe periodontitis with exacerbating features. Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
No measurements were reported for this outcome.
Periapical radiographs will be taken at baseline (preoperative) then at 2 years follow up post root canal filling Radiographically, Following periapical index (PAI) by Órstavik 1986, description of radiographic findings: 1. Normal periapical structures. 2. Small changes in the bone structure. 3. Change in the bone structure with mineral loss. 4. Periodontitis with a well-defined radiolucent area. 5. Severe periodontitis with exacerbating features. Success is defined as either complete (radiographic resolution of a periapical lesion - the radiographic sign of inflammatory processes surrounding a root tip) or incomplete healing (scar tissue formation) and failure includes uncertain healing (radiographic reduction of a periapical lesion or same lesion size) or unsatisfactory healing (increase in lesion size) as determined on the radiograph.
No measurements were reported for this outcome.
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 6 months follow up. Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts. Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
No measurements were reported for this outcome.
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 1 year follow up. Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts. Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
No measurements were reported for this outcome.
Clinical signs and symptoms: Pain, swelling, percussion sensitivity and sinus tracts measured at 2 years follow up. Clinically success is defined by the absence of pain, swelling, percussion sensitivity or sinus tracts. Clinical failure is defined as the persistent presence of any of the signs and symptoms mentioned above.
No measurements were reported for this outcome.
Tooth survival is defined as the presence of the tooth inside the mouth. Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
No measurements were reported for this outcome.
Tooth survival is defined as the presence of the tooth inside the mouth. Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
No measurements were reported for this outcome.
Tooth survival is defined as the presence of the tooth inside the mouth. Success: Tooth is still present in the oral cavity. Failure: Tooth is extracted for any reason.
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Waterlase Express™, BIOLASE® | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Sodium Hypochlorite | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Waterlase Express™, BIOLASE® | Sodium Hypochlorite | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 26 | 26 | 52 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Waterlase Express™, BIOLASE® | Sodium Hypochlorite | Total |
|---|---|---|---|
| Mean | 45 ± 2 | 44.125 ± 2 | 44.57 ± 2 |
| Sex: Female, Male(Participants) | Waterlase Express™, BIOLASE® | Sodium Hypochlorite | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 13 | 13 | 26 |
| Race (NIH/OMB)(Participants) | Waterlase Express™, BIOLASE® | Sodium Hypochlorite | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 26 | 26 | 52 |
| Region of Enrollment(Participants) | Waterlase Express™, BIOLASE® | Sodium Hypochlorite | Total |
|---|---|---|---|
| United States | 26 | 26 | 52 |
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University of Pennsylvania