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

September 22, 2025 updated by: University of Pennsylvania

A Clinical Use of Er,Cr:YSGG Laser: an Anti-biofilm 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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:
  • Er,Cr:YSGG laser
  • Waterlase Express™
Active Comparator: Sodium Hypochlorite
Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl).
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 Names:
  • NaOCl

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling.
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.
Measured at 6 months (± 7 days) post root canal filling.
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.
Measured at 1 year (± 7 days) post root canal filling.
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.
Measured at 2 years (± 7 days) post root canal filling.
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)
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).
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

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)
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)
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

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)
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
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:

  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 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
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:

  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 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
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:

  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 measured at baseline and 2 years follow up (± 7 days) post root canal filling.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

May 2, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 853701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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