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

University of Pennsylvania

Status: Terminated

Conditions: Root Canal Infection; Endodontic Disease

Treatments: Other: Sodium Hypochlorite; Device: Waterlase Express™, BIOLASE®

Study type: Interventional

Funder types: Other

Identifiers

NCT05959629

853701

Details and patient eligibility

About

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.

Full 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).

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Waterlase Express™, BIOLASE®

Experimental group

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).

Treatment:

Device: Waterlase Express™, BIOLASE®

Sodium Hypochlorite

Active Comparator group

Description:

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

Treatment:

Other: Sodium Hypochlorite