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Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques

Primary Purpose

Tooth,Non-vital

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conventional needle irrigation
passive ultrasonic irrigation
sonic irrigation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth,Non-vital

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males or Females
  • Age between 16-60 years old

  • Permanent Mandibular molars with:

    • Non-vital response of pulp tissue
    • Absence of spontaneous pain

Exclusion Criteria:

  • Pregnant females
  • Patients having significant systemic disorder
  • Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours

  • Teeth that have:

    • Vital pulp tissues
    • Association with swelling or fistulous tract
    • Acute periapical abscess
    • Greater than grade I mobility
    • Pocket depth greater than 5mm
    • Previous endodontic treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    conventional needle irrigation

    passive ultrasonic irrigation

    sonic irrigation

    Arm Description

    side-vented needle used for endodontic irrigation

    IrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment

    Vibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time

    Outcomes

    Primary Outcome Measures

    postoperative pain measured by numerical rate scale
    Numerical rate scale (NRS) consists of a line graded from 0-10 where 0 indicates no pain and 10 indicates worst pain, patient will choose the number that describe his pain level.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 20, 2016
    Last Updated
    September 22, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02912286
    Brief Title
    Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques
    Official Title
    Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    May 2019 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.
    Detailed Description
    Different irrigation delivery systems are introduced to the market aiming to improve root canals disinfection. The conventional endodontic needle is commonly used because of its ease in use and good control of needle depth and irrigant volume. However it carries a higher risk of extruding the solution periapically because of positive pressure used in solution delivery. Passive ultrasonic irrigation is a noncutting irrigation technique that is done with ultrasonically activated files with continuous or intermittent flow of irrigant. It was shown that it is effective in removing remnants of pulp tissue, dentin debris and planktonic bacteria. The vibringe (Cavex Holland BV, Haarlem, the Netherlands) is an irrigation device that combines manual delivery and sonic activation of the irrigant. The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth,Non-vital

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    conventional needle irrigation
    Arm Type
    Active Comparator
    Arm Description
    side-vented needle used for endodontic irrigation
    Arm Title
    passive ultrasonic irrigation
    Arm Type
    Experimental
    Arm Description
    IrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment
    Arm Title
    sonic irrigation
    Arm Type
    Experimental
    Arm Description
    Vibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time
    Intervention Type
    Device
    Intervention Name(s)
    conventional needle irrigation
    Intervention Description
    conventional side-vented syringe used to deliver irrigant in root canal treatment
    Intervention Type
    Device
    Intervention Name(s)
    passive ultrasonic irrigation
    Intervention Description
    ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment
    Intervention Type
    Device
    Intervention Name(s)
    sonic irrigation
    Intervention Description
    vibringe system is a sonic device that deliver and agitate the irrigant
    Primary Outcome Measure Information:
    Title
    postoperative pain measured by numerical rate scale
    Description
    Numerical rate scale (NRS) consists of a line graded from 0-10 where 0 indicates no pain and 10 indicates worst pain, patient will choose the number that describe his pain level.
    Time Frame
    4 hours after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males or Females Age between 16-60 years old Permanent Mandibular molars with: Non-vital response of pulp tissue Absence of spontaneous pain Exclusion Criteria: Pregnant females Patients having significant systemic disorder Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours Teeth that have: Vital pulp tissues Association with swelling or fistulous tract Acute periapical abscess Greater than grade I mobility Pocket depth greater than 5mm Previous endodontic treatment

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques

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