search
Back to results

Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems

Primary Purpose

Pulpitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2Shape rotary system
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis focused on measuring mandibular molars

Eligibility Criteria

22 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - Medically free patients.
  • Patients with symptomatic pulpitis in one of their mandibular molars.
  • Patient's age ranges between 22 to 45 years with no sex predilection.
  • Patients who can understand Numerical Analogue Scales (NRS).
  • Patients able to sign informed consent.

Exclusion Criteria:

  • - Patients having a systemic disorder.
  • Presence of periapical lesion.
  • Pregnant females.
  • Patients who had taken analgesics during the last 12 hours preoperatively.
  • Patients having active pain in more than one tooth.
  • Non- educated patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    2Shape rotary system

    Protaper Next rotary system

    Arm Description

    root canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis

    root canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis

    Outcomes

    Primary Outcome Measures

    intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain
    using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree

    Secondary Outcome Measures

    Need for / and number of analgesic tablets taken.
    incidence and number of analgesic tablets will be recorded

    Full Information

    First Posted
    September 29, 2018
    Last Updated
    October 1, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03694743
    Brief Title
    Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems
    Official Title
    Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    October 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
    Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2Shape and Protaper Next rotary systems.
    Detailed Description
    Root canal preparation is the most important step in endodontic treatment. For successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.However, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up. Instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. It has been reported that rotary NiTi systems cause less debris extrusion than manual instrumentation. Within NiTi systems, instrument design, taper and tip size were found to affect debris extrusion. Therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence. Therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis. The aim of the present study is to assess the effect of rotary instrumentation using Protaper Next rotary system versus 2Shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis. Primary objective: Comparing the intensity of post-operative pain using Numerical Rating Scale (NRS) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours. Secondary objectives: The need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment. Instrument separation during instrumentation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis
    Keywords
    mandibular molars

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Double (Participant, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    2Shape rotary system
    Arm Type
    Experimental
    Arm Description
    root canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis
    Arm Title
    Protaper Next rotary system
    Arm Type
    Active Comparator
    Arm Description
    root canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis
    Intervention Type
    Device
    Intervention Name(s)
    2Shape rotary system
    Intervention Description
    root canal preparation
    Primary Outcome Measure Information:
    Title
    intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain
    Description
    using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    Need for / and number of analgesic tablets taken.
    Description
    incidence and number of analgesic tablets will be recorded
    Time Frame
    3 days
    Other Pre-specified Outcome Measures:
    Title
    incidence of instrument seperation during endodontic treatment (instrument seperation means instrument fracture)
    Description
    incidence will be recorded
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Medically free patients. Patients with symptomatic pulpitis in one of their mandibular molars. Patient's age ranges between 22 to 45 years with no sex predilection. Patients who can understand Numerical Analogue Scales (NRS). Patients able to sign informed consent. Exclusion Criteria: - Patients having a systemic disorder. Presence of periapical lesion. Pregnant females. Patients who had taken analgesics during the last 12 hours preoperatively. Patients having active pain in more than one tooth. Non- educated patients.

    12. IPD Sharing Statement

    Learn more about this trial

    Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems

    We'll reach out to this number within 24 hrs