Clinical trial NCT05959629: 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
Overall status: RECRUITING
Phase: NA
Conditions: Endodontic Disease
Root Canal Infection
Keywords: Root Canal Irrigants
lasers
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Primary purpose: TREATMENT

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).

Eligibility criteria: 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, 1 distal canal of lower molar, 1 palatal canal of upper molar.

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.

Primary outcomes:
measure: The change in bacterial count between the experimental group (laser) and the standard of care (NaOCl) group (routinely used irrigation protocol).
timeFrame: 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 outcomes:
measure: Mean Change from Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS)
timeFrame: 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
measure: Mean Change from Baseline in Pain Scores at 24-hours After the Procedure on a Numeric Rating Scale (NRS)
timeFrame: 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
measure: Mean Change from Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)
timeFrame: 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
measure: Periapical Bone Changes from Baseline in Periapical Radiographs at 6 Months Follow Up
timeFrame: Periapical bone changes measured at baseline and 6 months follow up (± 7 days) post root canal filling.
measure: Periapical Bone Changes from Baseline in Periapical Radiographs at 1 Year Follow Up
timeFrame: Periapical bone changes measured at baseline and 1 year follow up (± 7 days) post root canal filling.
measure: Periapical Bone Changes from Baseline in Periapical Radiographs at 2 Years Follow Up
timeFrame: Periapical bone changes measured at baseline and 2 years follow up (± 7 days) post root canal filling.
measure: Presence of Clinical Signs or Symptoms at 6 Months Follow Up
timeFrame: Clinical signs and symptoms measured at 6 months (± 7 days) post root canal filling.
measure: Presence of Clinical Signs or Symptoms at 1 Year Follow Up
timeFrame: Clinical signs and symptoms measured at 1 year (± 7 days) post root canal filling.
measure: Presence of Clinical Signs or Symptoms at 2 Years Follow Up
timeFrame: Clinical signs and symptoms measured at 2 years (± 7 days) post root canal filling.
measure: Tooth Survival at 6 Months Follow Up
timeFrame: Measured at 6 months (± 7 days) post root canal filling.
measure: Tooth Survival at 1 Year Follow Up
timeFrame: Measured at 1 year (± 7 days) post root canal filling.
measure: Tooth Survival at 2 Years Follow Up
timeFrame: Measured at 2 years (± 7 days) post root canal filling.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, School of Dental Medicine
state: Pennsylvania
Study officials:
affiliation: Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director.
name: Bekir Karabucak, DMD, MS.
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Department of Basic & Translational Sciences
name: Flavia Teles, DDS,MS,DMSc
role: PRINCIPAL_INVESTIGATOR
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