Endodontic Disease, Root Canal Infection
Conditions
Keywords
Root Canal Irrigants, lasers
Brief summary
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.
Detailed description
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).
Interventions
DEVICEWaterlase 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 The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).
OTHERSodium Hypochlorite
Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants are assigned to one of two groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female (Gender is not an inclusion or
Exclusion criteria
), aged 18 years old or above. * In good general health as evidenced by medical history or non-contributory medical history (Patient can be seen for regular dental appointment in Penn Dental Medicine; American Society of Anesthesiologists (ASA) classes I and II). * Radiographic presence of periapical radiolucency. * Negative response to thermal sensitivity testing (difluorochloromethane at -50 °C, Endo-Ice, Coltène/Whaledent Inc., Cuyahoga Falls, Ohio) or electric pulp testing. * Enough tooth structure for adequate isolation with rubber dam. * No history of previous endodontic treatment on the tooth. * Teeth with single canal, 1 distal canal of lower molar, 1 palatal canal of upper molar.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome: Mean Change From Baseline in Pain Scores at 24 Hours After the Procedure on a Numeric Rating Scale (NRS). | 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) |
| Mean Change From Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS) | 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) |
| Periapical Bone Changes From Baseline in Periapical Radiographs at 6 Months Follow Up | Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling. | 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. |
| Periapical Bone Changes From Baseline in Periapical Radiographs at 1 Year Follow Up | Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling. | 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. |
| Periapical Bone Changes From Baseline in Periapical Radiographs at 2 Years Follow Up | Periapical bone changes measured at baseline and 2 years follow up (± 7 days) post root canal filling. | 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. |
| Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS) | 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) |
| Presence of Clinical Signs or Symptoms at 1 Year Follow Up | Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling. | 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. |
| Presence of Clinical Signs or Symptoms at 2 Years Follow Up | Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling. | 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. |
| Tooth Survival at 6 Months Follow Up | Measured at 6 months (± 7 days) post root canal filling. | 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. |
| Tooth Survival at 1 Year Follow Up | Measured at 1 year (± 7 days) post root canal filling. | 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. |
| Tooth Survival at 2 Years Follow Up | Measured at 2 years (± 7 days) post root canal filling. | 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. |
| Presence of Clinical Signs or Symptoms at 6 Months Follow Up | Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 26 |
| 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. | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | partially necrotic/technical issues | 2 | 2 |
Baseline characteristics
| Characteristic | Sodium Hypochlorite | Total | Waterlase Express™, BIOLASE® |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 52 Participants | 26 Participants |
| Age, Continuous | 44.125 years STANDARD_DEVIATION 2 | 44.57 years STANDARD_DEVIATION 2 | 45 years STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants | 52 Participants | 26 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 26 Participants | 52 Participants | 26 Participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waterlase Express™, BIOLASE® | 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 |
| Sodium Hypochlorite | The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). | 4.373858908 Mean CFU | Standard Deviation 2.532760244 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waterlase Express™, BIOLASE® | 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 |
| Sodium Hypochlorite | The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). | 2.570435011 Mean CFU | Standard Deviation 2.413322255 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waterlase Express™, BIOLASE® | 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 |
| Sodium Hypochlorite | The Change in Bacterial Count Between the Experimental Group (Laser) and the Standard of Care (NaOCl) Group (Routinely Used Irrigation Protocol). | 8.601200494 Mean CFU | Standard Deviation 2.99841829 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waterlase Express™, BIOLASE® | 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 |
| Sodium Hypochlorite | Mean Change From Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS) | 2.20 score on a scale | Standard Deviation 1.5 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Waterlase Express™, BIOLASE® | 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 |
| Waterlase Express™, BIOLASE® | 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 |
| Sodium Hypochlorite | Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS) | t0 | 2.38 units on a scale | Standard Deviation 3.68 |
| Sodium Hypochlorite | Mean Change From Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS) | t4 | 2.67 units on a scale | Standard Deviation 2.66 |
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waterlase Express™, BIOLASE® | 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 |
| Sodium Hypochlorite | Secondary Outcome: Mean Change From Baseline in Pain Scores at 24 Hours After the Procedure on a Numeric Rating Scale (NRS). | 1.13 score on a scale | Standard Deviation 1.92 |
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.
Secondary
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.
Population: The study was terminated. Data were not collected for this measure at any time point.~Unable to follow up participants due to their geographic location and other reasons.