Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser in Root Canal Disinfection

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Clinical Use of Er,Cr:YSGG Laser: an Anti-biofilm Treatment

Conditions
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Endodontic Disease, Root Canal Infection

Intervention / Treatment
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* Device: Waterlase Express™, BIOLASE®
* Other: Sodium Hypochlorite


Participation Criteria
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Eligibility Criteria
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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 and lower molars with two mesial canals. Exclusion Criteria: Patients who report they are pregnant. Teeth affected by dental trauma. Periodontal changes (pockets 3 mm, mobility I or gingival edema). Radiographic presence of resorptive processes. Per the investigator's discretion, unable or unlikely to comply with study procedure. Presence of any condition which, in the opinion of the investigator, makes participation in the study not in the individual's best interest.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel for the duration of the study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Waterlase Express™, BIOLASE®<br>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®<br>* 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).<br>* Other names: Waterlase Express™;|
| Active Comparator: Sodium Hypochlorite<br>Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl). | Other: Sodium Hypochlorite<br>* Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.<br>* Other names: NaOCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in bacterial count between the experimental group (laser) and the standard of care (NaOCl) group (routinely used irrigation protocol). | By measuring reduction 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. | All samples will be taken during the first root canal treatment visit.Sample1 before cleaning or shaping the root canal.Sample2 after cleaning and shaping of the root canal using laser or NaOCl.Sample3 Upon completion of final routine irrigation protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 
| Mean Change from Baseline in Pain Scores at 24-hours After the Procedure on a Numeric Rating Scale (NRS) | Patients will be asked to rate the intensity of postoperative pain at 24-hours after the procedure. Change = (24 hours score - baseline score) | 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) | Patients will be asked to rate the intensity of postoperative pain at 48-hours after the procedure. Change = (48 hours score - baseline score) | 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: Normal periapical structures. Small changes in the bone structure. Change in the bone structure with mineral loss. Periodontitis with a well-defined radiolucent area. 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 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: Normal periapical structures. Small changes in the bone structure. Change in the bone structure with mineral loss. Periodontitis with a well-defined radiolucent area. 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 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: Normal periapical structures. Small changes in the bone structure. Change in the bone structure with mineral loss. Periodontitis with a well-defined radiolucent area. 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 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. | 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. | 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. | 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. | 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. | 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. | Measured at 2 years (± 7 days) post root canal filling. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Root Canal Irrigants, lasers