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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
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 moreAwards & 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).
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.
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.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,073 Previous Clinical Trials
42,714,306 Total Patients Enrolled
Bekir Karabucak, DMD, MS.Principal InvestigatorChair and Professor of Endodontics. Postdoctoral Endodontics Program, Director.
Flavia Teles, DDS,MS,DMScPrincipal InvestigatorAssociate Professor, Department of Basic & Translational Sciences
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tooth with only one canal needing treatment.I am 18 years old or older.My teeth have been damaged by an injury.I have mild gum disease with some tooth mobility or swelling.My teeth have enough structure for safe dental procedures.My tooth has never had a root canal treatment.My tooth has one canal or my lower molar has two front canals.
Research Study Groups:
This trial has the following groups:- Group 1: Sodium Hypochlorite
- Group 2: Waterlase Express™, BIOLASE®
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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