Laser Disinfection for Root Canal Infections

Recruiting in Palo Alto (17 mi)

Overseen by Flavia Teles, DDS,MS,DMSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Dental trauma, Periodontal changes, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Er,Cr:YSGG Laser for root canal infections?

Research shows that the Er,Cr:YSGG laser is effective in killing bacteria in root canals, especially when used with sodium hypochlorite, a common disinfectant. This laser treatment has been shown to significantly reduce bacteria like Enterococcus faecalis, which is often found in root canal infections. ^{1 2 3 4 5}

Is the Er,Cr:YSGG laser safe for use in humans?

The Er,Cr:YSGG laser has been studied for its use in dental procedures, and while it is effective in cleaning root canals, one study noted it caused slightly more damage to the tooth pulp (the soft tissue inside the tooth) compared to traditional methods. However, it did not affect the eruption (growth) of teeth in rats, suggesting it may be generally safe with careful use. ^{1 2 3 6 7}

How does the Er,Cr:YSGG laser treatment differ from other treatments for root canal infections?

The Er,Cr:YSGG laser treatment is unique because it uses a specific type of laser that emits light at a wavelength of 2.78 micrometers to kill bacteria in root canals. Unlike traditional methods like sodium hypochlorite (a common disinfectant), this laser can target bacteria deep within the dentin while minimizing damage to surrounding tissues. ^{1 2 3 4 8}

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

Eligibility Criteria

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

I am 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Findings from Research

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]

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]

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 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]

References

1. England 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. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Bactericidal activity of erbium, chromium:yttrium-scandium-gallium-garnet laser in root canals. [2021]

3. England 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. [2022]

4. China pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2020]

6. England 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. [2018]

7. United States 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. [2017]

8. United States 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. [2019]