Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser in Root Canal Disinfection
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ClinicalTrials.gov Identifier: NCT05959629 |
Recruitment Status :
Recruiting
First Posted : July 25, 2023
Last Update Posted : February 16, 2024
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Condition or disease | Intervention/treatment | Phase |
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Endodontic Disease Root Canal Infection | Device: Waterlase Express™, BIOLASE® Other: Sodium Hypochlorite | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants are assigned to one of two groups in parallel for the duration of the study |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Use of Er,Cr:YSGG Laser: an Anti-biofilm Treatment |
Actual Study Start Date : | October 11, 2023 |
Estimated Primary Completion Date : | July 2025 |
Estimated Study Completion Date : | July 2027 |
Arm | Intervention/treatment |
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Experimental: 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).
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Device: 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 The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).
Other Names:
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Active Comparator: Sodium Hypochlorite
Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl).
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Other: Sodium Hypochlorite
Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.
Other Name: NaOCl |
- The change in bacterial count between the experimental group (laser) and the standard of care (NaOCl) group (routinely used irrigation protocol). [ Time Frame: 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 ]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.
- Mean Change from Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS) [ 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 ]
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)
- Mean Change from Baseline in Pain Scores at 24-hours After the Procedure on a Numeric Rating Scale (NRS) [ 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 ]
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) [ 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 ]
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 [ Time Frame: 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:
- 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 from Baseline in Periapical Radiographs at 1 Year Follow Up [ Time Frame: 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:
- 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 from Baseline in Periapical Radiographs at 2 Years Follow Up [ Time Frame: 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:
- 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.
- Presence of Clinical Signs or Symptoms at 6 Months Follow Up [ Time Frame: 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.
- Presence of Clinical Signs or Symptoms at 1 Year Follow Up [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959629
Contact: Dana Mominkhan, B.D.S | 773-610-2393 | danakhan@upenn.edu | |
Contact: Bekir Karabucak | 215-898-4927 | bekirk@upenn.edu |
United States, Pennsylvania | |
University of Pennsylvania, School of Dental Medicine | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Bekir Karabucak, DMD, MS. | Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director. | |
Principal Investigator: | Flavia Teles, DDS,MS,DMSc | Associate Professor, Department of Basic & Translational Sciences |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT05959629 |
Other Study ID Numbers: |
853701 |
First Posted: | July 25, 2023 Key Record Dates |
Last Update Posted: | February 16, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Root Canal Irrigants lasers |
Dental Pulp Diseases Tooth Diseases Stomatognathic Diseases Sodium Hypochlorite |
Eusol Disinfectants Anti-Infective Agents |