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Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root canal treatment using TruNaomy rotary files
Root canal treatment using race rotary instruments
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are free from any physical or mental handicapping condition and no contributory systemic disease.
  • Age between 30-60 years old.
  • Males & Females.
  • Patients' acceptance for participating in the trial through an informed consent

  • Maxillary permanent premolar teeth:

    • Diagnosed clinically and radiographically with pulp necrosis
    • With or without periapical radiolucency
    • Negative response of pulp tissue to cold test (ethyl chloride) and electric pulp tester
    • Possessing two independent roots each having a type I canal
    • Patent canals with no internal calcification or resorptive lesions
    • Fully formed roots
    • Root curvatures less than 30

Exclusion Criteria:

  • Patient with contributory medical condition
  • Badly destructed teeth
  • Patients with pre-operative pain
  • Patients having significant systemic disorders
  • Patients with two or more adjacent teeth requiring root canal therapy
  • Patients who had received antibiotics in the last month

  • Teeth presenting with:

    • Positive response to cold test (ethyl chloride) or electric pulp tester
    • History of trauma or previous endodontic treatment
    • Immature or open apices
    • Association with acute periapical abscess and swelling or fistulous tract
    • Fused roots at any level
    • Canals larger than size 15# K-file
    • Periodontonal/ endodontic lesions
    • Mobility higher than grade I
    • Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
    • Severe root curvature (>30)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Root canal treatment using RaCe rotary system

    Root canal treatment using TruNatomy rotary system

    Arm Description

    Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity

    Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity

    Outcomes

    Primary Outcome Measures

    Post operative pain using visual analogue scale
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
    Post operative pain using visual analogue scale
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
    Post operative pain using visual analogue scale
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
    Post operative pain using visual analogue scale
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible

    Secondary Outcome Measures

    operative torque generated during instrumentation
    real time operative torque exerted on the instrument through out the shaping process and until the instrument reaches the full working length will be measured using a torque measuring motor in real time
    time required for the instrument to reach the full working length
    time required for the the instrument to reach the full length and complete the shaping process will be calculated using a Realtime torque motoring motor

    Full Information

    First Posted
    October 8, 2020
    Last Updated
    October 29, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04616469
    Brief Title
    Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation
    Official Title
    Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    November 1, 2021 (Anticipated)
    Study Completion Date
    January 1, 2022 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of: Post operative pain: incidence and intensity Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor Time needed for the instruments to reach to the full working length

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Root canal treatment using RaCe rotary system
    Arm Type
    Active Comparator
    Arm Description
    Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity
    Arm Title
    Root canal treatment using TruNatomy rotary system
    Arm Type
    Experimental
    Arm Description
    Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity
    Intervention Type
    Procedure
    Intervention Name(s)
    Root canal treatment using TruNaomy rotary files
    Intervention Description
    Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system
    Intervention Type
    Procedure
    Intervention Name(s)
    Root canal treatment using race rotary instruments
    Intervention Description
    Race rotary files will be used for the process of cleaning and shaping of the root canal system
    Primary Outcome Measure Information:
    Title
    Post operative pain using visual analogue scale
    Description
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
    Time Frame
    at 24 hours post treatment
    Title
    Post operative pain using visual analogue scale
    Description
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
    Time Frame
    at 48 hours post treatment
    Title
    Post operative pain using visual analogue scale
    Description
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
    Time Frame
    at 72 hours post treatment
    Title
    Post operative pain using visual analogue scale
    Description
    pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
    Time Frame
    at 1 week post treatment
    Secondary Outcome Measure Information:
    Title
    operative torque generated during instrumentation
    Description
    real time operative torque exerted on the instrument through out the shaping process and until the instrument reaches the full working length will be measured using a torque measuring motor in real time
    Time Frame
    during treatment
    Title
    time required for the instrument to reach the full working length
    Description
    time required for the the instrument to reach the full length and complete the shaping process will be calculated using a Realtime torque motoring motor
    Time Frame
    during treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who are free from any physical or mental handicapping condition and no contributory systemic disease. Age between 30-60 years old. Males & Females. Patients' acceptance for participating in the trial through an informed consent Maxillary permanent premolar teeth: Diagnosed clinically and radiographically with pulp necrosis With or without periapical radiolucency Negative response of pulp tissue to cold test (ethyl chloride) and electric pulp tester Possessing two independent roots each having a type I canal Patent canals with no internal calcification or resorptive lesions Fully formed roots Root curvatures less than 30 Exclusion Criteria: Patient with contributory medical condition Badly destructed teeth Patients with pre-operative pain Patients having significant systemic disorders Patients with two or more adjacent teeth requiring root canal therapy Patients who had received antibiotics in the last month Teeth presenting with: Positive response to cold test (ethyl chloride) or electric pulp tester History of trauma or previous endodontic treatment Immature or open apices Association with acute periapical abscess and swelling or fistulous tract Fused roots at any level Canals larger than size 15# K-file Periodontonal/ endodontic lesions Mobility higher than grade I Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification. Severe root curvature (>30)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tarek Ali e mosalamy, MSc
    Phone
    01000089261
    Ext
    002
    Email
    Tarek072501@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31891973
    Citation
    Gambarini G, Galli M, Seracchiani M, Di Nardo D, Versiani MA, Piasecki L, Testarelli L. In Vivo Evaluation of Operative Torque Generated by Two Nickel-Titanium Rotary Instruments during Root Canal Preparation. Eur J Dent. 2019 Oct;13(4):556-562. doi: 10.1055/s-0039-1698369. Epub 2019 Dec 31.
    Results Reference
    background
    PubMed Identifier
    27790254
    Citation
    Zand V, Milani AS, Hassani Dehkharghani A, Rahbar M, Tehranchi P. Treatment of Necrotic Teeth Using Two Engine-Driven Systems and Patient's Postoperative Pain: A Double-Blind Clinical Trial. Iran Endod J. 2016 Fall;11(4):267-272. doi: 10.22037/iej.2016.3.
    Results Reference
    background

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    Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation

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