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Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual glide path
Mechanical glide path
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

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient age above 18-70 years old.
  • Both males and females will be included.
  • All patients are in a good health without systemic condition.
  • The offending tooth is a molar.
  • The offending molar is indicated for root canal treatment.
  • One molar for every patient.
  • All patients will sign an informed consent.

Exclusion Criteria:

  • 1. The offending tooth has previous attempt of pulp therapy or root canal treatment.
  • 2. The patient showing any clinical or radiographic evidence of periapical pathosis.
  • 3. Patients received analgesics or systemic antibiotic prior to treatment.

    -.4 Immunocompromised patients.

  • 5. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
  • 6. History of cancer with radio or chemotherapy.
  • 7. Offending molar with mobility score ≥2.
  • 8. Offending molar with pocket depth ≥6mm.
  • 9. Immature molars.
  • 10. Nonodontogenic pain.
  • 11. Patients with more than one tooth requiring endodontic intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Manual glide path

    mechanical glide path

    Arm Description

    manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver

    glide path will be established using rotary Ni-Ti files in a reciprocating maneuver

    Outcomes

    Primary Outcome Measures

    postoperative pain
    postoperative pain after root canal treatment using VAS
    postoperative pain
    postoperative pain after root canal treatment using VAS
    postoperative pain
    postoperative pain after root canal treatment using VAS
    postoperative pain
    postoperative pain after root canal treatment using VAS
    postoperative pain
    postoperative pain after root canal treatment using VAS

    Secondary Outcome Measures

    Full Information

    First Posted
    December 26, 2021
    Last Updated
    January 11, 2022
    Sponsor
    Cairo University
    Collaborators
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05206214
    Brief Title
    Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain
    Official Title
    Effect of Manual Glide Path Versus Mechanical Glide Path Establishment on Endodontic Postoperative Pain. A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur. In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device. Canals were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds.
    Detailed Description
    All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur. In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device. Canals were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland). Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.

    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
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual glide path
    Arm Type
    Experimental
    Arm Description
    manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver
    Arm Title
    mechanical glide path
    Arm Type
    Experimental
    Arm Description
    glide path will be established using rotary Ni-Ti files in a reciprocating maneuver
    Intervention Type
    Procedure
    Intervention Name(s)
    Manual glide path
    Intervention Description
    manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. . Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.
    Intervention Type
    Procedure
    Intervention Name(s)
    Mechanical glide path
    Intervention Description
    glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.
    Primary Outcome Measure Information:
    Title
    postoperative pain
    Description
    postoperative pain after root canal treatment using VAS
    Time Frame
    after 4 hours after root canal treatment
    Title
    postoperative pain
    Description
    postoperative pain after root canal treatment using VAS
    Time Frame
    after 6hours after root canal treatment
    Title
    postoperative pain
    Description
    postoperative pain after root canal treatment using VAS
    Time Frame
    after 12hours after root canal treatment
    Title
    postoperative pain
    Description
    postoperative pain after root canal treatment using VAS
    Time Frame
    after 24hours after root canal treatment
    Title
    postoperative pain
    Description
    postoperative pain after root canal treatment using VAS
    Time Frame
    after 48 hours after root canal treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient age above 18-70 years old. Both males and females will be included. All patients are in a good health without systemic condition. The offending tooth is a molar. The offending molar is indicated for root canal treatment. One molar for every patient. All patients will sign an informed consent. Exclusion Criteria: 1. The offending tooth has previous attempt of pulp therapy or root canal treatment. 2. The patient showing any clinical or radiographic evidence of periapical pathosis. 3. Patients received analgesics or systemic antibiotic prior to treatment. -.4 Immunocompromised patients. 5. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.) 6. History of cancer with radio or chemotherapy. 7. Offending molar with mobility score ≥2. 8. Offending molar with pocket depth ≥6mm. 9. Immature molars. 10. Nonodontogenic pain. 11. Patients with more than one tooth requiring endodontic intervention.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba A ElAsfouri, AssProfessor
    Phone
    +201005276232
    Email
    heba.elasfouri@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mostafa I Negm
    Phone
    00201227696110
    Email
    mostafaibrahim923@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heba A ElAsfouri
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25886847
    Citation
    Wu H, Peng C, Bai Y, Hu X, Wang L, Li C. Shaping ability of ProTaper Universal, WaveOne and ProTaper Next in simulated L-shaped and S-shaped root canals. BMC Oral Health. 2015 Mar 1;15:27. doi: 10.1186/s12903-015-0012-z.
    Results Reference
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    Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain

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