search
Back to results

Incidence of Post-Operative Pain After Single Visit Root Canal Treatment in Necrotic Teeth Using Two Different Rotary Systems (Protaper Nex t& Neolix File)

Primary Purpose

Necrotic Pulp

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

About this trial

This is an interventional treatment trial for Necrotic Pulp focused on measuring post operative pain, Post operative flare ups, Post endodontic pain, Post endodontic flare ups, Necrotic teeth, Non vital teeth, Neolix file, Single rotating file, Protaper next file, Multiple rotating file, Single visit

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Medically free patients.
  • Patient's age (20-65) years old.
  • Upper &lower anterior and premolar teeth diagnosed clinically as necrotic teeth.
  • Positive patient's acceptance for participation in the study.
  • Sex includes both male and female.
  • Patients who can understand Numerical Rating Scale.
  • Patients able to sign informed consent.

Exclusion Criteria:

  • • Pregnancy or lactation.

    • Medically compromised patients.
    • Patient with multiple teeth that required treatment to eliminate the possibility of pain referral.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    protaper next file

    Arm Description

    the PROTAPER NEXT™ X1 (017/04) file, in one or more passes until the working length is reached. Use PROTAPER NEXT X2 (025/06), exactly as described for PROTAPER NEXT X1 file, until the working length is passively reached. Gauge the foramen with a size 025 hand file and, if this file binds at length, the canal is shaped and ready for disinfection. If the size 025 hand file is loose at length, then continue shaping with the PROTAPER NEXT X3 (30/07) and, when necessary, the PROTAPER NEXT X4 (040/06) or PROTAPER NEXT X5 (050/06), gauging after each instrument with the 030, 040 or 050 hand files, respectively. During canal shaping, irrigate, recapitulate with a small-sized hand file after each sequential PROTAPER NEXT instrument, then re-irrigate. in an endodontic motor according to the manufacturer instructions (X-Smart, Dentsply Maillefer, USA.), with torque 2.0 N.cm and speed 300 rpm.

    Outcomes

    Primary Outcome Measures

    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation
    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation
    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation
    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2017
    Last Updated
    February 16, 2017
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03059290
    Brief Title
    Incidence of Post-Operative Pain After Single Visit Root Canal Treatment in Necrotic Teeth Using Two Different Rotary Systems (Protaper Nex t& Neolix File)
    Official Title
    Incidence of Post-Operative Pain After Single Visit Root Canal Treatment in Necrotic Teeth Using Two Different Rotary Systems (Protaper Nex t& Neolix File)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2017 (Anticipated)
    Primary Completion Date
    November 1, 2017 (Anticipated)
    Study Completion Date
    December 1, 2017 (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
    this prospective in vivo randomized clinical is to evaluate the post operative pain (incidence ,degree and duration) with multiple full rotation file (protaper next ®) and single full rotation file (Neolix®) in treating maxillary and mandibular anterior and premolar with chronic pulpitis .Together with our aim from this trial ; we are trying to provide an evidence for the dentists in order to provide the best quality service with the least expenses and thus gaining the patients' trust and saving time, money and effort.
    Detailed Description
    Interventions: Using neolix file (Ori kam SAS,France) Control: Using Protaper next files (Dentsply ,Maillefer , Switzerland) Treatment in all cases will be completed in one session as follows: Full medical and dental history using a schematic dental chart will be obtained from all patients treated during this study. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues using electric pulp tester (Kerr, Analytic Technology Crop, Redmond, WA). Patient will be anesthetized; teeth will be isolated with rubber dam. Make access and working length will be determined using an electronic apex locator (Root ZX, J.Morita USA, Irvine, CA.) then confirmed with intraoral periapical radiograph, to be 0.5-1 mm, shorter than radiographic apex. Cleaning and shaping will be done using crown down preparation technique with rotary files either neolix file , first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani ,Japan ) is loose or pass easily in the canal , but in case of K-file size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with (X-Smart, Dentsply Maillefer, USA.), with speed 300-500 rpm and torque 1.5 N.cm or protaper next in sequences by using Prepare straight line access to canal orifice. The ProTaper SX file may be used. Explore the canal using small-sized hand files, determine working length, verify patency and confirm a smooth, reproducible glide path. Always irrigate and if necessary, expand the glide path using small-sized hand files or dedicated mechanical glide path files. Path Files P1 and P2 are recommended. In the presence of NaOCl, brush and follow the glide path, with the PROTAPER NEXT™ X1 (017/04) file, in one or more passes until the working length is reached. Use PROTAPER NEXT X2 (025/06), exactly as described for PROTAPER NEXT X1 file, until the working length is passively reached. Gauge the foramen with a size 025 hand file and, if this file binds at length, the canal is shaped and ready for disinfection. If the size 025 hand file is loose at length, then continue shaping with the PROTAPER NEXT X3 (30/07) and, when necessary, the PROTAPER NEXT X4 (040/06) or PROTAPER NEXT X5 (050/06), gauging after each instrument with the 030, 040 or 050 hand files, respectively. During canal shaping, irrigate, recapitulate with a small-sized hand file after each sequential PROTAPER NEXT instrument, then re-irrigate. in an endodontic motor according to the manufacturer instructions (X-Smart, Dentsply Maillefer, USA.), with torque 2.0 N.cm and speed 300 rpm. The rotary files will be introduced inside the canal using EDTA gel "MD-Chelcream, META BIOMED CO.,LTD, Korea". The canals will be thoroughly irrigated using 3 ml of 2.5% Sodium hypochlorite between every subsequent instrument. After instrumentation of the canals, paper points will be used for drying. Obturation will be carried out using gutta percha cones (25/0.6 or 40/0.4) Or Protaper next cones according to instrument used and canal size with resin sealer (ADSEAL, META BIOMED CO., LTD,Korea).After obturation a cotton pellet will be placed in the pulp chamber and the access cavity will be closed with a temporary filling to avoid coronal leakage. ((MD-Temp, META BIOMED CO., LTD, Korea). The patient is given a Numerical Rating Scale and asked to rate his pain level at 6, 12, 24 & 48 hours after obturation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Pulp
    Keywords
    post operative pain, Post operative flare ups, Post endodontic pain, Post endodontic flare ups, Necrotic teeth, Non vital teeth, Neolix file, Single rotating file, Protaper next file, Multiple rotating file, Single visit

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    protaper next file
    Arm Type
    Active Comparator
    Arm Description
    the PROTAPER NEXT™ X1 (017/04) file, in one or more passes until the working length is reached. Use PROTAPER NEXT X2 (025/06), exactly as described for PROTAPER NEXT X1 file, until the working length is passively reached. Gauge the foramen with a size 025 hand file and, if this file binds at length, the canal is shaped and ready for disinfection. If the size 025 hand file is loose at length, then continue shaping with the PROTAPER NEXT X3 (30/07) and, when necessary, the PROTAPER NEXT X4 (040/06) or PROTAPER NEXT X5 (050/06), gauging after each instrument with the 030, 040 or 050 hand files, respectively. During canal shaping, irrigate, recapitulate with a small-sized hand file after each sequential PROTAPER NEXT instrument, then re-irrigate. in an endodontic motor according to the manufacturer instructions (X-Smart, Dentsply Maillefer, USA.), with torque 2.0 N.cm and speed 300 rpm.
    Intervention Type
    Device
    Intervention Name(s)
    neolix file
    Intervention Description
    first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani ,Japan ) is loose or pass easily in the canal , but in case of K-file size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with (X-Smart, Dentsply Maillefer, USA.), with speed 300-500 rpm and torque 1.5 N.cm
    Primary Outcome Measure Information:
    Title
    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation
    Time Frame
    6 hours
    Title
    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation
    Time Frame
    12 hours
    Title
    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation
    Time Frame
    24 hours
    Title
    the Incidence of postoperative pain in root canal treatment with necrotic tooth after obturation
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Medically free patients. Patient's age (20-65) years old. Upper &lower anterior and premolar teeth diagnosed clinically as necrotic teeth. Positive patient's acceptance for participation in the study. Sex includes both male and female. Patients who can understand Numerical Rating Scale. Patients able to sign informed consent. Exclusion Criteria: • Pregnancy or lactation. Medically compromised patients. Patient with multiple teeth that required treatment to eliminate the possibility of pain referral.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    karim ahmed nahas, master degree candidate
    Phone
    +201006300519
    Email
    karimnahas34@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    siza yacoub el zakhary, professor
    Phone
    +201006621083
    Email
    siza.yacoub@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nehal nabil, assistant professor
    Organizational Affiliation
    faculty of oral and dental medicine - cairo university
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Incidence of Post-Operative Pain After Single Visit Root Canal Treatment in Necrotic Teeth Using Two Different Rotary Systems (Protaper Nex t& Neolix File)

    We'll reach out to this number within 24 hrs