What is the mechanism of action of this treatment?

The Er,Cr:YSGG laser treatment for root canals works by emitting laser energy that disrupts and eliminates bacterial biofilms within the canal. This laser energy penetrates the dentinal tubules, significantly reducing bacterial load and removing smear layers and debris. For root canal patients, this means a more thorough disinfection process, which can lead to better treatment outcomes and a lower risk of reinfection. The moderate temperature rise during laser use also ensures minimal damage to surrounding tissues, making it a safe and effective treatment option.

What side effects are associated with this type of intervention?

Common treatments for root canal therapy include mechanical debridement, chemical irrigation, and laser-based treatments like the Er,Cr:YSGG laser. Known side effects of traditional root canal treatments can include post-operative pain, swelling, infection, and in rare cases, damage to surrounding tissues. Laser-based treatments, such as the Er,Cr:YSGG laser, are generally well-tolerated but can cause mild discomfort, temporary sensitivity, and a slight increase in temperature during the procedure. These lasers are effective in eliminating bacteria and biofilms, potentially reducing the risk of post-treatment infection.

What prior FDA approvals exist?

The FDA has approved the Er,Cr:YSGG laser for complete endodontic therapy, including root canal treatments. This laser technology is used for access, debridement, and shaping of the canal, and it has shown effectiveness in eliminating bacteria and biofilms within the root canal system. The Er,Cr:YSGG laser is notable for its ability to remove smear layers and open dentinal tubules, enhancing the overall disinfection process during endodontic procedures.

What other types of research exist?

Promising alternatives to the Er,Cr:YSGG laser for root canal treatment in 2024 include: 1) Low-Level Laser Therapy (LLLT), which has shown potential in improving healing and reducing symptoms related to dental infections. 2) Ozone Therapy, which has been suggested to have benefits in decontaminating dental biofilms. 3) Autologous Platelet Concentrates (APC), which may enhance healing and reduce infection when used in conjunction with surgical procedures. These alternatives offer different mechanisms for biofilm disruption and infection control, providing various options for root canal patients.

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Procedure

Laser Disinfection for Root Canal Infections

N/A

Recruiting

Led By Bekir Karabucak, DMD, MS.

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special laser treatment to clean and disinfect teeth during root canal procedures. The laser uses light to kill bacteria and remove slimy layers of germs inside the tooth. The study will compare this laser treatment to the usual cleaning method to see which works better. Diode lasers have been shown to provide better clinical outcomes in root canal disinfection compared to conventional methods.

Who is the study for?

This trial is for adults over 18 in good health with specific dental pulp diseases, who need root canal treatment. They must have a tooth that can be isolated and no history of trauma or prior endodontic work on it. Pregnant individuals or those with certain periodontal issues are excluded.

What is being tested?

The study aims to develop a disinfection protocol using an FDA-approved Er,Cr:YSGG laser during routine root canal treatments. It will assess the laser's effectiveness against biofilms compared to traditional antibacterial methods like Sodium Hypochlorite.

What are the potential side effects?

Potential side effects may include discomfort at the site of treatment, sensitivity in the treated tooth, and possible irritation of surrounding gum tissue due to laser application.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The change in bacterial count between the experimental group (laser) and the standard of care (NaOCl) group (routinely used irrigation protocol).

Secondary study objectives

Mean Change from Baseline in Pain Scores at 24-hours After the Procedure on a Numeric Rating Scale (NRS)

Mean Change from Baseline in Pain Scores at 4-hours After the Procedure on a Numeric Rating Scale (NRS)

Mean Change from Baseline in Pain Scores at 48-hours After the Procedure on a Numeric Rating Scale (NRS)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Waterlase Express™, BIOLASE®Experimental Treatment1 Intervention

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).

Group II: Sodium HypochloriteActive Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Er,Cr:YSGG laser treatment for root canals works by emitting laser energy that disrupts and eliminates bacterial biofilms within the canal. This laser energy penetrates the dentinal tubules, significantly reducing bacterial load and removing smear layers and debris. For root canal patients, this means a more thorough disinfection process, which can lead to better treatment outcomes and a lower risk of reinfection. The moderate temperature rise during laser use also ensures minimal damage to surrounding tissues, making it a safe and effective treatment option.

Bactericidal effect of Er,Cr:YSGG laser irradiation on endodontic biofilm: An ex vivo study.Evaluation of the bactericidal effect of Er,Cr:YSGG, and Nd:YAG lasers in experimentally infected root canals.The use of the erbium, chromium:yttrium-scandium-gallium-garnet laser in endodontic treatment: the results of an in vitro study.