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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
Study Summary
This trial tests if a laser treatment can disinfect the canal system during endodontic treatment, to fight biofilms and compare to other antibacterial protocols.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in bacterial count between the experimental group (laser) and the standard of care (NaOCl) group (routinely used irrigation protocol).
Secondary outcome measures
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 moreTrial 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).
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,235 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
Media Library
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: Waterlase Express™, BIOLASE®
- Group 2: Sodium Hypochlorite
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being admitted to this clinical trial?
"As of July 17th 2023, this clinical trial is no longer recruiting. However, there are 18 other medical studies presently enrolling participants as per information found on clinicaltrials.gov."
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Who else is applying?
What site did they apply to?
University of Pennsylvania, School of Dental Medicine
What portion of applicants met pre-screening criteria?
Met criteria
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