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

Last updated: February 15, 2024
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Sodium Hypochlorite

Waterlase Express™, BIOLASE®

Clinical Study ID

NCT05959629
853701
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for theduration of the study.
  • Male or female (Gender is not an inclusion or exclusion criteria), aged 18 years oldor above.
  • In good general health as evidenced by medical history or non-contributory medicalhistory (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 uppermolar.

Exclusion

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, makesparticipation in the study not in the individual's best interest.

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Sodium Hypochlorite
Phase:
Study Start date:
October 11, 2023
Estimated Completion Date:
July 31, 2027

Study 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).

Connect with a study center

  • University of Pennsylvania, School of Dental Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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