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

NCT05959629 | Terminated Results DMC FDA Device

• 1 other identifier: 853701
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease; Root Canal Infection

Keywords

Root Canal Irrigants; lasers

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (12)

• 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

• 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

• 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

• 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 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.

Study Arms (2)

Waterlase Express™, BIOLASE®

EXPERIMENTAL

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®

Sodium Hypochlorite

ACTIVE COMPARATOR

Root canals will be instrumented up to size 30/0.04 taper using standard of care (NaOCl).

Other: Sodium Hypochlorite

Interventions

Waterlase Express™, BIOLASE® DEVICE

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™

Waterlase Express™, BIOLASE®

Sodium Hypochlorite OTHER

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

Sodium Hypochlorite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Results Point of Contact

• Title: Dr. Bekir Karabucak
• Organization: University of Pennsylvania School of Dental Medicine

bekirk@upenn.edu

215-898-4927

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 25, 2023
• Study Start: October 11, 2023
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)