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Effect Of Simultaneous Working Length Control Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
simultaneous working length control using E-CONNECT S
separate length determination and root canal preparation using Root ZX apex locator.
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

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between (20-50) years old with symptomatic irreversible pulpitis in permanent mandibular premolar teeth.
  • Systemically- healthy patients (ASA I or II).
  • Patients who agree to attend for recall appointments and provide written consent.

Exclusion Criteria:

  • Pregnant women and patients with pacemakers.
  • Patients with bruxism or clenching or have taken analgesics during past 24 hours.
  • Moderate or severe marginal periodontitis (i.e. pocket probing >3 mm).
  • Necrotic pulp, pulp polyp, tooth tender to percussion, preoperative palpation pain, clinical progression into periapical abscess, fistula.
  • Teeth with internal or external resorption, curvatures, open apices, root canal obliteration, perforation, incomplete root formation, teeth previously undergone root canal treatment, absence of opposing tooth to the related tooth or radiographically invisible canals.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    simultaneous working length control

    Root ZX apex locator.

    Arm Description

    • Using simultaneous working length control during root canal preparation using E-CONNECT S endomotor with integrated apex locator.

    Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.

    Outcomes

    Primary Outcome Measures

    Postoperative pain after endodontic treatment
    Intensity of postoperative pain will be measured using Visual Analogue scale (VAS) for pain assessment 7 days after the end of endodontic treatment. It uses numerical data: None 0, Mild <20, Moderate 20-50 and Sever >50.

    Secondary Outcome Measures

    Number of analgesic tablets taken by the patient after endodontic treatment.
    Number of analgesic tablets taken by the patient after endodontic treatment.

    Full Information

    First Posted
    March 8, 2019
    Last Updated
    March 31, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03899129
    Brief Title
    Effect Of Simultaneous Working Length Control Postoperative Pain
    Official Title
    Effect Of Simultaneous Working Length Control During Root Canal Preparation Versus Electronic Apex Locator On Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis (a Randomized Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    May 2020 (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

    5. Study Description

    Brief Summary
    The aim of this study was to evaluate the effect of simultaneous length control during root canal preparation on postoperative pain compared with separate working length determination and root canal preparation using electronic apex locator. During preparation of root canals, loss of working length (WL) can lead to instrumentation beyond the predefined apical limit of the preparation. This effect is mainly attributed to straightening of the root canal during instrumentation. Some studies showed, that this kind of over instrumentation as well as under instrumentation can adversely affect the outcome of the endodontic treatment, while it remains uncertain what exactly is the most favorable extent of the apical limit of root canal preparation. Furthermore, all endodontic instruments produce apical extrusion of debris, even when the preparation is kept within the confines of the root canal. Consequently, preparations ending in the periapical tissue will produce a greater amount of debris extrusion that could elicit a neurogenic inflammatory response resulting from an irritation of the periodontal ligament with subsequent postoperative symptomatic apical periodontitis. Therefore, it seems favorable to control the determined WL during root canal preparation to avoid preparations ending in the periapical tissue.
    Detailed Description
    During preparation of root canals, loss of working length (WL) can lead to instrumentation beyond the predefined apical limit of the preparation. This effect is mainly attributed to straightening of the root canal during instrumentation. Some studies showed, that this kind of over instrumentation as well as under instrumentation can adversely affect the outcome of the endodontic treatment. Furthermore, all endodontic instruments produce apical extrusion of debris, even when the preparation is kept within the confines of the root canal. Consequently, preparations ending in the periapical tissue will produce a greater amount of debris extrusion that could result from an irritation of the periodontal ligament with subsequent postoperative symptomatic apical periodontitis. Therefore, it seems favorable to control the determined WL during root canal preparation to avoid preparations ending in the periapical tissue. Endodontic motors with integrated apex locators offer a solution to the described problem as they have been developed with the intention of making root canal treatment easier and faster. Besides torque and speed control, these devices also aim to continuously monitor and control the apical limit all the way through the mechanical preparation of the root canals and have an auto apical reverse (AAR) function that stops and reverse the rotation when the file tip reaches the predetermined apical limit of the preparation. E-CONNECT S (Eighteeth medical technology Co., Ltd, china) is an endomotor with integrated apex locator newly introduced in the market with continuous WL measuring function. It contains an optional module for rotary instrumentation, allowing the device to function as a low-speed hand piece, apex locator, or a combination of both. This motor has an attention-grabbing property that when an instrument reaches the predetermined working length, the motor automatically stops the instrumentation. Thus, it can be concluded that automatically stopping instrumentation when the instrument reaches the working length would decrease postoperative pain compared with manually controlling the working length by using stoppers during instrumentation (separate length determination and root canal preparation). The Root ZX (J Morita, Tokyo, Japan) is a third generation EAL where no calibration is necessitated, and a microprocessor analyzes the impedance quotient. It uses multiple frequencies to calculate the distance from the end of the canal. To measure location within the canal, third generation units (including Root ZX EAL) still use impedance measurements but have stronger microprocessors and can process the mathematical quotient and algorithm calculations required to obtain accurate readings. The change in electrical capacitance at the apical constriction is the basis for the operation of the Root ZX and its reported accuracy, even in presence of different electrolytes in the canal and under different clinical conditions; that's why it is considered the most commonly used apex locator.

    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
    Model Description
    Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The study will be participant-blind where the participants will not know the intervention done. The applications could not be blinded; however, the statistician will be blinded.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    simultaneous working length control
    Arm Type
    Experimental
    Arm Description
    • Using simultaneous working length control during root canal preparation using E-CONNECT S endomotor with integrated apex locator.
    Arm Title
    Root ZX apex locator.
    Arm Type
    Active Comparator
    Arm Description
    Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.
    Intervention Type
    Procedure
    Intervention Name(s)
    simultaneous working length control using E-CONNECT S
    Intervention Description
    E-CONNECT S (Eighteeth medical technology Co., Ltd, china) is an endomotor with integrated apex locator newly introduced in the market with continuous WL measuring function. It contains an optional module for rotary instrumentation, allowing the device to function as a low-speed handpiece, apex locator, or a combination of both. This motor has an attention-grabbing property that when an instrument reaches the predetermined working length, the motor automatically stops the instrumentation. Thus, it can be concluded that automatically stopping instrumentation when the instrument reaches the working length would decrease postoperative pain compared with manually controlling the working length by using stoppers during instrumentation (separate length determination and root canal preparation).
    Intervention Type
    Procedure
    Intervention Name(s)
    separate length determination and root canal preparation using Root ZX apex locator.
    Intervention Description
    Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.
    Primary Outcome Measure Information:
    Title
    Postoperative pain after endodontic treatment
    Description
    Intensity of postoperative pain will be measured using Visual Analogue scale (VAS) for pain assessment 7 days after the end of endodontic treatment. It uses numerical data: None 0, Mild <20, Moderate 20-50 and Sever >50.
    Time Frame
    7 days after root canal treatment.
    Secondary Outcome Measure Information:
    Title
    Number of analgesic tablets taken by the patient after endodontic treatment.
    Description
    Number of analgesic tablets taken by the patient after endodontic treatment.
    Time Frame
    Until 7 days after endodontic treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between (20-50) years old with symptomatic irreversible pulpitis in permanent mandibular premolar teeth. Systemically- healthy patients (ASA I or II). Patients who agree to attend for recall appointments and provide written consent. Exclusion Criteria: Pregnant women and patients with pacemakers. Patients with bruxism or clenching or have taken analgesics during past 24 hours. Moderate or severe marginal periodontitis (i.e. pocket probing >3 mm). Necrotic pulp, pulp polyp, tooth tender to percussion, preoperative palpation pain, clinical progression into periapical abscess, fistula. Teeth with internal or external resorption, curvatures, open apices, root canal obliteration, perforation, incomplete root formation, teeth previously undergone root canal treatment, absence of opposing tooth to the related tooth or radiographically invisible canals.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aml M moteleb
    Phone
    20-01092359661
    Email
    aml.abdelmoteleb@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba elasfouri
    Phone
    20-01005276232
    Email
    Heba.elasfouri@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aml M moteleb
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified individual participant data for all primary and secondary outcome measures will be made available
    IPD Sharing Time Frame
    data will be available within 6 months from study completion
    IPD Sharing Access Criteria
    Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

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    Effect Of Simultaneous Working Length Control Postoperative Pain

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