RECRUITING

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

Conditions

Endodontic Disease Root Canal Infection Root Canal Irrigants lasers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-11

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05959629

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Dana Mominkhan, B.D.S

CONTACT

773-610-2393

danakhan@upenn.edu

Bekir Karabucak

CONTACT

215-898-4927

bekirk@upenn.edu

Principal Investigator

Bekir Karabucak, DMD, MS.

PRINCIPAL_INVESTIGATOR

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

Flavia Teles, DDS,MS,DMSc

PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Basic & Translational Sciences

Study Locations (Sites)

University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Bekir Karabucak, DMD, MS., PRINCIPAL_INVESTIGATOR, Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director.
Flavia Teles, DDS,MS,DMSc, PRINCIPAL_INVESTIGATOR, Associate Professor, Department of Basic & Translational Sciences

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 Registration Dates

Study Start Date2023-10-11

Study Completion Date2027-07

Study Record Updates

Study Start Date2023-10-11

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

Root Canal Irrigants
lasers

Additional Relevant MeSH Terms

Endodontic Disease
Root Canal Infection