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Laser Activated Irrigation Versus Passive Ultrasonic Irrigation

Primary Purpose

Pulp Necroses

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser activated irrigation
Passive ultrasonic irrigation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necroses

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Medically free patients.
  • Patients with necrotic pulp in single rooted teeth with:

    • Closed apex.
    • Associated with or without periapical radiolucency.
    • No response of vital pulp with the electric pulp tester.
  • Healthy dental and periodontal status.
  • Positive patients' acceptance for participation in the study.

Exclusion Criteria i. Patients on medication for chronic pain. ii. Patients with pre-operative pain. iii. Patients having significant systemic disorders. iv. Patients with two or more adjacent teeth requiring root canal therapy. v. Patients who had received antibiotics in the last month. vi. Teeth that have:

  • Vital pulp tissues.
  • Association with swelling or fistulous tract.
  • Acute peri-apical abscess.
  • Greater than grade I mobility.
  • Pocket depth greater than 5mm.
  • No possible restorability.
  • Previous endodontic treatment.
  • Open apex.
  • Extra coronal restorations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Laser activated irrigation

    Passive ultrasonic irrigation

    Arm Description

    Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device

    passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device

    Outcomes

    Primary Outcome Measures

    Post-operative pain 6 hours post-operatively: NRS
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)
    Post-operative pain 12 hours post-operatively: NRS
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)
    Post-operative pain 24 hours post-operatively: NRS
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)
    Post-operative pain 48 hours post-operatively: NRS
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)

    Secondary Outcome Measures

    change in intracanal bacterial flora count
    bacterial cultures made from microbiological samples taken at different stages of the endodontic treatment. The bacteria will be counted as colony forming units (CFUs). There are three samples that are taken during the endodontic treatment : S1: After Access cavity preparation. S2: After chemomechanical preparation S3: After using the intervention or control. The CFUs will be counted in the culture obtained from each sample then a comparison will be made between the intervention and control groups regarding the difference in the number of CFUs in S2 between S3

    Full Information

    First Posted
    July 19, 2019
    Last Updated
    July 26, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04035083
    Brief Title
    Laser Activated Irrigation Versus Passive Ultrasonic Irrigation
    Official Title
    Evaluation of Post-operative Pain and Bacterial Reduction Following Laser Activated Irrigation Versus Passive Ultrasonic Irrigation in Necrotic Single Rooted Teeth: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    assessment of bacterial reduction and post-operative pain following Laser activated irrigation using sodium hypochlorite and a 980 nm diode laser device as an adjunct to conventional root canal treatment, and comparing it with passive ultrasonic irrigation using sodium hypochlorite and an ultrasonic device in patients with single rooted asymptomatic necrotic teeth.
    Detailed Description
    After thorough diagnosis and recording of the patient's perceived preoperative pain using the numeric rating scale (NRS), which should be zero. Patients with single rooted necrotic teeth will be randomly divided into two groups for endodontic treatment in a single visit: Group LAI (in which laser activated irrigation will be done) and group PUI (in which passive ultrasonic irrigation will be done). The teeth are anesthetized and isolation is done. the clamp, tooth crown and rubber dam are disinfected using 2.5% sodium hypochlorite and 30% hydrogen peroxide then sodium thiosulphate to neutralize their effects. Removal of caries and defective restorations is done, followed by access cavity preparation using round burs and fine tapered stones. then the first microbiological sample is taken using paper points. Afterwards root canal preparation is done using Protaper Next files and irrigation is done using 2.5% sodium hypochlorite and a 30 -gauge side vented needle. After chemomechanical preparation of the canal, the second microbiological sample is taken, afterwards the canals are filled with sodium hypochlorite and according to the group, the following is done: In group LAI: the 200 micrometer fibre of the diode laser device enters the root canal and the device is activated at a setting of 980 nm and 1.5 Watts for 5 seconds, repeated 4 times with a 10 seconds gap in between. In group PUI: the ultrasonic device is activated inside the canal using a passive non cutting tip and kept activated for 1 minute. Then, irrigation with saline solution is done then the third microbiological sample is taken, afterwards obturation is done and temporization. the patient is referred to the restorative dentistry clinic to complete the restoration of his tooth. The patient is instructed to record his pain at 6,12,24 and 48 hours postoperatively and the microbiological samples are analyzed

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necroses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Laser activated irrigation
    Arm Type
    Experimental
    Arm Description
    Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device
    Arm Title
    Passive ultrasonic irrigation
    Arm Type
    Active Comparator
    Arm Description
    passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device
    Intervention Type
    Device
    Intervention Name(s)
    Laser activated irrigation
    Intervention Description
    Diode laser at 980 nm, power of 1.5W, for 5 seconds inside the canal along with sodium hypochlorite, repeated 4 times with a gap of 10 seconds in between
    Intervention Type
    Device
    Intervention Name(s)
    Passive ultrasonic irrigation
    Intervention Description
    ultrasonic activation inside the canal for 1 min
    Primary Outcome Measure Information:
    Title
    Post-operative pain 6 hours post-operatively: NRS
    Description
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)
    Time Frame
    6 hours after endodontic treatment
    Title
    Post-operative pain 12 hours post-operatively: NRS
    Description
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)
    Time Frame
    12 hours after endodontic treatment
    Title
    Post-operative pain 24 hours post-operatively: NRS
    Description
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)
    Time Frame
    24 hours after endodontic treatment
    Title
    Post-operative pain 48 hours post-operatively: NRS
    Description
    Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)
    Time Frame
    48 hours after endodontic treatment
    Secondary Outcome Measure Information:
    Title
    change in intracanal bacterial flora count
    Description
    bacterial cultures made from microbiological samples taken at different stages of the endodontic treatment. The bacteria will be counted as colony forming units (CFUs). There are three samples that are taken during the endodontic treatment : S1: After Access cavity preparation. S2: After chemomechanical preparation S3: After using the intervention or control. The CFUs will be counted in the culture obtained from each sample then a comparison will be made between the intervention and control groups regarding the difference in the number of CFUs in S2 between S3
    Time Frame
    48 hours after endodontic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Medically free patients. Patients with necrotic pulp in single rooted teeth with: Closed apex. Associated with or without periapical radiolucency. No response of vital pulp with the electric pulp tester. Healthy dental and periodontal status. Positive patients' acceptance for participation in the study. Exclusion Criteria i. Patients on medication for chronic pain. ii. Patients with pre-operative pain. iii. Patients having significant systemic disorders. iv. Patients with two or more adjacent teeth requiring root canal therapy. v. Patients who had received antibiotics in the last month. vi. Teeth that have: Vital pulp tissues. Association with swelling or fistulous tract. Acute peri-apical abscess. Greater than grade I mobility. Pocket depth greater than 5mm. No possible restorability. Previous endodontic treatment. Open apex. Extra coronal restorations.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr Ahmed, MSc
    Phone
    +201224382216
    Email
    dramrayman1@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shaimaa Gawdat, PhD
    Organizational Affiliation
    central evidence based dentistry committee
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31050955
    Citation
    Dagher J, El Feghali R, Parker S, Benedicenti S, Zogheib C. Postoperative Quality of Life Following Conventional Endodontic Intracanal Irrigation Compared with Laser-Activated Irrigation: A Randomized Clinical Study. Photobiomodul Photomed Laser Surg. 2019 Apr;37(4):248-253. doi: 10.1089/photob.2018.4558.
    Results Reference
    background
    PubMed Identifier
    30144989
    Citation
    Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Different Irrigation Agitation Techniques on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Oct;44(10):1451-1456. doi: 10.1016/j.joen.2018.06.008. Epub 2018 Aug 23.
    Results Reference
    background

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