The Efficacy of Laser in Root Canal Disinfection

November 24, 2023 updated by: Sara Zakaria Fahim, Future University in Egypt

The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial

The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

  • Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  • Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  • Group C(Combined): saline along with 17% EDTA and diode laser combination Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of lasers in disinfection of the root canal has been recently implemented. Lasers have bactericidal effect, and have deep penetration depth inside the root canal up to 1000 um. Thus, it can be used effectively for disinfection of the root canal system following biomechanical instrumentation reaching areas which were considered before non-reachable.

The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

  • Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  • Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  • Group C(Combined): saline along with 17% EDTA and diode laser combination After disinfection, local anesthetic and tooth isolation and access cavity preparation, the first microbial samples (S1) will be collected using 3 sterile paper points and immediately placed inside sterile tubes containing transport medium of thioglycolate, cleaning and shaping with final disinfection protocol will be performed according to the group in which the participant was allocated to. Followed by S2 sample. obturation using warm vertical compaction technique. Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbassia
      • Cairo, Abbassia, Egypt, 11566
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Patients who are medically free.

    • Patient's age between 18-35 years.
    • One single rooted maxillary anterior tooth with necrotic pulp and asymptomatic apical periodontitis requiring root canal treatment.
    • Patients complaining of no pain and without fistulous tract.
    • Periapical lesion with a periapical index score of 3 or 4 (Ørstavik, et al. (1986)108
    • Closed apex.
    • Acceptance to participate in the study.

Exclusion Criteria:

  • Patients suffering from any systemic disease.
  • Patients who had received antibiotics during the last month.
  • Patients taking analgesics 12 hours before interventions.
  • Patients with history of tobacco usage
  • Teeth with vital pulp, calcified canals, and immature or incompletely formed apices.
  • Teeth with previous endodontic treatment.
  • Non restorable teeth where rubber dam could not be applied.
  • Teeth with periodontal pocket more than 3 mm.
  • Teeth with greater than grade 1 mobility.
  • Teeth with swelling/sinus tract.

  • Technical difficulties in the course of root canal treatment for example:

    • A tooth with curved roots

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional group A
Combination product: Conventional group (NaOCl/EDTA)
conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
Experimental: Dual laser group B
Combination product: Dual laser group (Er,Cr:YSGG/Diode):
Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection
Experimental: Combined group C
Combination product: Combined group (EDTA/Diode):
17% EDTA was used to remove smear layer followed by diode laser for disinfection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative microbiological analysis
Time Frame: baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]

aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).

anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).
baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative microbiological analysis
Time Frame: baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit

aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).

anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).
baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Collaborators

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-Rec ID 041908

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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