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

NCT ID: NCT05959629

Last Updated: 2025-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-11

Study Completion Date

2024-05-02

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).

Conditions

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Endodontic Disease Root Canal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of two groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Waterlase Express™, BIOLASE®

Intervention Type 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).

Sodium Hypochlorite

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

Group Type ACTIVE_COMPARATOR

Sodium Hypochlorite

Intervention Type OTHER

Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.

Interventions

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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).

Intervention Type DEVICE

Sodium Hypochlorite

Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.

Intervention Type OTHER

Other Intervention Names

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Er,Cr:YSGG laser Waterlase Express™ NaOCl

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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bekir Karabucak, DMD, MS.

Role: PRINCIPAL_INVESTIGATOR

Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director.

Flavia Teles, DDS,MS,DMSc

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Basic & Translational Sciences

Locations

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University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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853701

Identifier Type: -

Identifier Source: org_study_id

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