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Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Twisted file adaptive
Reciproc
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, reciproc, twisted file adaptive

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients who are medically free from any systemic disease that may contraindicate our interventions.
  2. Patient's age between 18-60 years old.
  3. Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22.
  4. Positive patient's acceptance for participation in the study.

Exclusion Criteria:

  1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation.
  2. Teeth with vital pulps or Symptomatic irreversible pulpitis.
  3. Pregnant patients or lactating because of radiographic hazards and use of analgesics27.
  4. Any known sensitivity or adverse reactions to ibuprofen.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Twisted file adaptive

    Reciproc

    Arm Description

    Files that are used in root canal preparation in adaptive motion

    Reciproc files are used in root canal preparation with reciprocation motion

    Outcomes

    Primary Outcome Measures

    Post instrumentation pain
    post instrumentation pain will be recorded by the patient using numerical rating scale (0-10) will be used to record pain intensity

    Secondary Outcome Measures

    analgesic intake
    number of analgesic intake will be recorded by the patient
    Colony forming units
    calculation of colony forming units before and after instrumentation

    Full Information

    First Posted
    November 3, 2017
    Last Updated
    November 7, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03338322
    Brief Title
    Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive
    Official Title
    Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive In Instrumentation Of Necrotic Mandibular Molars: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    December 2018 (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
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    assess the effect of using reciprocating motion with reciproc files versus adaptive motion using twisted file adaptive on postoperative pain after instrumentation of necrotic mandibular molars.
    Detailed Description
    In root canal treatment of mandibular molar teeth in patients having necrotic pulp with symptomatic or asymptomatic apical periodontitis, Is there difference in postoperative pain after instrumentation between two different kinematics; adaptive motion using Twisted File Adaptive and reciprocation motion using Reciproc

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    postoperative pain, reciproc, twisted file adaptive

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Twisted file adaptive
    Arm Type
    Experimental
    Arm Description
    Files that are used in root canal preparation in adaptive motion
    Arm Title
    Reciproc
    Arm Type
    Active Comparator
    Arm Description
    Reciproc files are used in root canal preparation with reciprocation motion
    Intervention Type
    Device
    Intervention Name(s)
    Twisted file adaptive
    Intervention Description
    Endodontic files that are used in preparation of root canals with adaptive motion
    Intervention Type
    Device
    Intervention Name(s)
    Reciproc
    Intervention Description
    Endodontic files that are used in root canal preparation with reciprocation motion
    Primary Outcome Measure Information:
    Title
    Post instrumentation pain
    Description
    post instrumentation pain will be recorded by the patient using numerical rating scale (0-10) will be used to record pain intensity
    Time Frame
    up to 7 days
    Secondary Outcome Measure Information:
    Title
    analgesic intake
    Description
    number of analgesic intake will be recorded by the patient
    Time Frame
    up to 7 days
    Title
    Colony forming units
    Description
    calculation of colony forming units before and after instrumentation
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who are medically free from any systemic disease that may contraindicate our interventions. Patient's age between 18-60 years old. Mandibular molars having necrotic pulps with symptomatic or asymptomatic apical periodontitis because this group of patients may have more postoperative pain than vital teeth22. Positive patient's acceptance for participation in the study. Exclusion Criteria: Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain after instrumentation. Teeth with vital pulps or Symptomatic irreversible pulpitis. Pregnant patients or lactating because of radiographic hazards and use of analgesics27. Any known sensitivity or adverse reactions to ibuprofen.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    abu bakr
    Phone
    +201225877183
    Email
    ahmed.abubakr@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    participant data will be recorded and shared

    Learn more about this trial

    Postoperative Pain After Using Reciprocating Motion With Reciproc Files Versus Adaptive Motion With Twisted File Adaptive

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