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

Primary Purpose

Endodontic Disease, Root Canal Infection

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Waterlase Express™, BIOLASE®

Sodium Hypochlorite

About this trial

This is an interventional treatment trial for Endodontic Disease focused on measuring Root Canal Irrigants, lasers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Pennsylvania, School of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Waterlase Express™, BIOLASE®

Sodium Hypochlorite

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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)

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)

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 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 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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05959629

First Posted

July 5, 2023

Last Updated

October 23, 2023

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT05959629

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endodontic Disease, Root Canal Infection

Keywords

Root Canal Irrigants, lasers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Waterlase Express™, BIOLASE®

Arm Type

Experimental

Arm Description

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).

Arm Title

Sodium Hypochlorite

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Waterlase Express™, BIOLASE®

Other Intervention Name(s)

Er,Cr:YSGG laser, Waterlase Express™

Intervention Description

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

Other

Intervention Name(s)

Sodium Hypochlorite

Other Intervention Name(s)

NaOCl

Intervention Description

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

Primary Outcome Measure Information:

Title

The change in bacterial count between the experimental group (laser) and the standard of care (NaOCl) group (routinely used irrigation protocol).

Description

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.

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

Secondary Outcome Measure Information:

Title

Mean Change from Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS)

Description

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

Title

Mean Change from Baseline in Pain Scores at 24-hours After the Procedure on a Numeric Rating Scale (NRS)

Description

Patients will be asked to rate the intensity of postoperative pain at 24-hours after the procedure. Change = (24 hours score - baseline score)

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

Title

Mean Change from Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)

Description

Patients will be asked to rate the intensity of postoperative pain at 48-hours after the procedure. Change = (48 hours score - baseline score)

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

Title

Periapical Bone Changes from Baseline in Periapical Radiographs at 6 Months Follow Up

Description

Time Frame

Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling.

Title

Periapical Bone Changes from Baseline in Periapical Radiographs at 1 Year Follow Up

Description

Time Frame

Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling.

Title

Periapical Bone Changes from Baseline in Periapical Radiographs at 2 Years Follow Up

Description

Time Frame

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

Title

Presence of Clinical Signs or Symptoms at 6 Months Follow Up

Description

Time Frame

Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling.

Title

Presence of Clinical Signs or Symptoms at 1 Year Follow Up

Description

Time Frame

Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling.

Title

Presence of Clinical Signs or Symptoms at 2 Years Follow Up

Description

Time Frame

Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling.

Title

Tooth Survival at 6 Months Follow Up

Description

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.

Time Frame

Measured at 6 months (± 7 days) post root canal filling.

Title

Tooth Survival at 1 Year Follow Up

Description

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.

Time Frame

Measured at 1 year (± 7 days) post root canal filling.

Title

Tooth Survival at 2 Years Follow Up

Description

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.

Time Frame

Measured at 2 years (± 7 days) post root canal filling.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dana Mominkhan, B.D.S

Phone

773-610-2393

danakhan@upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Bekir Karabucak

Phone

215-898-4927

bekirk@upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bekir Karabucak, DMD, MS.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Flavia Teles, DDS,MS,DMSc

Organizational Affiliation

Associate Professor, Department of Basic & Translational Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania, School of Dental Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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

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