NCT05959629

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Endodontic Disease
• Root Canal Infection

Interventions

Type	Name	Description
DEVICE	Waterlase Express™, BIOLASE®	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 The tip will be activated and slowly withdrawn to the orifice (1-2mm/sec) following the manufacturer settings (energy 15 Millijoule (mJ), repetition rate 50 Hertz (Hz), 0% air, 0% water).
OTHER	Sodium Hypochlorite	Root canals will be instrumented up to size 30/0.04 taper using 1.5cc of 3% NaOCl in between files.

Timeline

• Start date: 2023-10-11
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2023-07-25
• Last updated: 2025-10-09
• Results posted: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study