Laser Disinfection for Root Canal Infections

Overseen By Bekir Karabucak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Dental trauma, Periodontal changes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1 visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for cleaning root canals using a special laser called the Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser. The researchers aim to determine if this laser treatment kills bacteria more effectively than the usual method with sodium hypochlorite. Suitable participants have a tooth needing a root canal with signs of infection but have not previously undergone a root canal on that tooth. The study compares the laser treatment with traditional cleaning to identify the more effective approach. As an unphased trial, it offers a unique opportunity to explore innovative dental treatments that could enhance root canal outcomes.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinator or your doctor.

What prior data suggests that this protocol is safe for root canal disinfection?

Studies have shown that the Er,Cr:YSGG laser, the type being tested in this study, is generally well-tolerated for root canal disinfection. Research indicates that this laser does not significantly increase temperature during treatment, which is crucial for safety. This reduces the risk of harming surrounding tissues in the mouth.

Additionally, the Er,Cr:YSGG laser has been successfully used in other dental procedures and is FDA-approved, meeting certain safety standards. Widespread reports of negative side effects have not emerged, suggesting its safety for this type of dental treatment. For those considering joining the trial, this evidence suggests that the laser treatment should be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Er,Cr:YSGG laser for root canal infections because it offers a new way to disinfect the canals. Unlike the standard of care, which typically uses sodium hypochlorite (a chemical solution) to clean the infected area, the laser uses light energy to target and kill bacteria more precisely. This method can potentially reduce the risk of missing infected areas and might even speed up the healing process. Plus, the laser treatment could minimize the use of harsh chemicals, making it a gentler option for patients.

What evidence suggests that this protocol is effective for root canal infections?

Research has shown that the Er,Cr:YSGG laser, which participants in this trial may receive, is promising for killing bacteria during root canal treatments. Studies have found that this laser effectively reduces germs in root canal infections. It sends energy that targets and destroys bacteria in the tooth's tiny channels. These hard-to-reach areas often hide bacteria that cause infections. Early findings suggest that this laser cleans more effectively than traditional methods. Overall, the Er,Cr:YSGG laser could improve root canal treatment by targeting and destroying harmful bacteria. ^{1 2 3 5 6}

Who Is on the Research Team?

Bekir Karabucak, DMD, MS.

Principal Investigator

Chair and Professor of Endodontics. Postdoctoral Endodontics Program, Director.

Flavia Teles, DDS,MS,DMSc

Principal Investigator

Associate Professor, Department of Basic & Translational Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a tooth with only one canal needing treatment.

Radiographic presence of periapical radiolucency

Provision of signed and dated informed consent form

Exclusion Criteria

Patients who report they are pregnant

Radiographic presence of resorptive processes

Presence of any condition which, in the opinion of the investigator, makes participation in the study not in the individual's best interest

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo root canal treatment with either standard of care irrigation protocol or Er,Cr:YSGG laser treatment

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for changes in bacterial count, periapical bone changes, and tooth survival

2 years

Multiple visits at 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser

Trial Overview 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.

How Is the Trial Designed?

Group I: Waterlase Express™, BIOLASE® Experimental Treatment 1 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 Hypochlorite Active Control 1 Intervention

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

Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) Laser is already approved in United States for the following indications:

Approved in United States as Waterlase for:

• Root Canal Disinfection
• Debridement
• Cleaning and disinfection for root canal procedures

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The combination of Er,Cr:YSGG laser and 5% NaOCl resulted in the highest elimination of Enterococcus faecalis bacteria in root canals, indicating a highly effective disinfection method.

While the Er,Cr:YSGG and Er,Cr:YSGG + Diode laser groups showed less bacterial elimination compared to 5% NaOCl, the results suggest that further research is needed to fully understand the potential of combining these laser treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bactericidal Effect of 2780 nm Er,Cr:YSGG Laser Combined with 940 nm Diode Laser in Enterococcus faecalis Elimination: A Comparative Study. Tokuc, M., Ozalp, S., Topcuoglu, N., et al.[2020]

The Er,Cr:YSGG laser demonstrated a strong bactericidal effect against Enterococcus faecalis in root canals, achieving results comparable to the most effective concentration of sodium hypochlorite (5%) when used at 2 W for 60 seconds.

Sodium hypochlorite at 5% concentration was the most effective treatment overall, while lower concentrations (0.5%) were less effective, highlighting the importance of optimal conditions for achieving maximum antimicrobial efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bactericidal activity of erbium, chromium:yttrium-scandium-gallium-garnet laser in root canals. Arnabat, J., Escribano, C., Fenosa, A., et al.[2021]

The Er,Cr:YSGG laser with radial emitting tips significantly reduces Enterococcus faecalis bacteria in infected dentin, achieving up to a 99.7% reduction in bacterial counts, especially with longer exposure times.

This laser treatment was found to be more effective than traditional sodium hypochlorite disinfection, suggesting it could be a valuable method for improving root canal disinfection during dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antimicrobial efficacy of the erbium, chromium:yttrium-scandium-gallium-garnet laser with radial emitting tips on root canal dentin walls infected with Enterococcus faecalis. Gordon, W., Atabakhsh, VA., Meza, F., et al.[2019]

Both Er,Cr:YSGG laser and ultrasonic irrigation methods significantly reduced bacteria in root canals after treatment, showing their effectiveness in root canal disinfection compared to a control group.

There was no significant difference in bacterial reduction between the Er,Cr:YSGG laser and ultrasonic irrigation groups, indicating that both methods are equally effective for antimicrobial activity in root canal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of antimicrobial activity of Er,Cr: YSGG laser and ultrasonic irrigation in root canal disinfection]. Lu, CH., Zhong, Q.[2019]

The study used theoretical simulations to assess how heat from Er,Cr:YSGG lasers spreads in the root canal system, revealing that some existing treatment protocols may not effectively kill bacteria in deep dentin, even with prolonged heating.

An alternative treatment protocol was identified that uses 350 mW laser power with repeated movement of the laser tip, effectively disinfecting deep dentin while keeping temperatures below 47 degrees Celsius to prevent thermal damage, potentially reducing treatment time and patient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of effectiveness of Er,Cr:YSGG laser for root canal disinfection: theoretical simulation of temperature elevations in root dentin. Zhu, L., Tolba, M., Arola, D., et al.[2019]

The study evaluated temperature changes during root canal treatment using Er,Cr:YSGG and 940 nm diode lasers on 18 human teeth, finding that maximum temperature increases were well below the critical threshold of 10°C, indicating safety.

The highest temperature increase was observed with the Er,Cr:YSGG laser alone (8.35°C), while the combination with the diode laser resulted in lower temperature rises, suggesting that alternating laser use is effective and safe for endodontic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Root Surface Temperature Changes During Root Canal Laser Irradiation with Dual Wavelength Laser (940 and 2780 nm): A Preliminary Study. Haidary, D., Franzen, R., Gutknecht, N.[2017]

The Er,Cr:YSGG laser effectively eliminates bacteria in root canals and removes the smear layer, enhancing the cleanliness of the canal walls, based on an in vitro study involving bacterial inoculation and quantitative microbiological evaluation.

The study showed that the disinfecting effect of the laser was influenced by the output power used, but the temperature increase during the procedure was moderate, indicating a low risk of thermal damage to the surrounding tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the erbium, chromium:yttrium-scandium-gallium-garnet laser in endodontic treatment: the results of an in vitro study. Schoop, U., Goharkhay, K., Klimscha, J., et al.[2022]

Er,Cr:YSGG laser irradiation effectively prepares root canals while maintaining the eruption of rat incisors, as both laser-treated and control teeth erupted at the same level after one week.

Histological analysis indicated that while the laser caused slightly more damage to the pulp compared to traditional K-files, it resulted in a cleaner and more irregular surface with open dentinal tubules, suggesting effective cleaning of the canal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Er,Cr:YSGG laser irradiation on eruption of rat mandibular incisor after disturbance of the enamel organ in the pulp. Masuda, YM., Hossain, M., Wang, X., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11632735/

Use of the Er,Cr:YSGG laser as an adjuvant in root canal ... This study investigated the antibacterial efficacy and cleaning capacity of the Er,Cr:YSGG laser in root canal disinfection.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10894764/

YSGG and 940 nm Diode Laser in root canal disinfection: A ... The aim of this study was to evaluate the effect of 2780 nm Er,Cr:YSGG and 940 nm diode lasers on the eradication of microorganisms from single-rooted teeth ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf7/K071363.pdf

J~ 07/34? - accessdata.fda.gov Er,Cr:YSGG (Waterlase®) and the evaluation of the temperature rise which related to the safety of these devices during root canal disinfection. Copies of the ...

4. endodonticsltd.com endodonticsltd.com/sites/default/files/gallery/Endo%20Peer%20Reviewed%20Aricles.pdf

Root Canal Therapy System for the Waterlase MD™ YSGG ... The results of this study suggest that the Er,Cr:YSGG laser with a radial emitting tip has a significant antimicrobial effect on dentinal tubules infected with ...

5. biolase.com biolase.com/media/Gordon-et-al.-The-antimicrobial-efficacy-of-the-ErCrYSGG-laser-with-radial-emitting-tips-on-root-canal-dentin-walls-infected-with-E-fa.pdf

garnet laser with radial emitting tips on root canal dentin ... The results of this study suggest that the Er,Cr:YSGG laser with a radial emitting tip has a significant antimicrobial effect on dentinal tubules infected with ...

6. biolase.com biolase.com/procedures/dentists/endo/

Root Canals and Waterlase Endodontics RESULTS. “The results of this study suggest that the Er,Cr:YSGG laser with a radial emitting tip has a significant antimicrobial effect on dentinal tubules ...