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Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next

Primary Purpose

Tooth, Nonvital

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

About this trial

This is an interventional treatment trial for Tooth, Nonvital focused on measuring necrotic teeth, single visit, multiple visits, protaper next

Eligibility Criteria

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

Inclusion criteria:

  • Medically free patients.
  • Patient's age above 18 years old.
  • Teeth diagnosed clinically with necrosis.
  • Positive patient's acceptance for participation in the study.
  • Sex includes both male and female.
  • Patients who can understand visual analogue scale.
  • Patients able to sign informed consent.

Exclusion criteria:

  • Pregnancy or lactation.
  • Medically compromised patients.
  • Patient with multiple teeth that required treatment in the same quadrant to eliminate the possibility of pain referral.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    single visit endodontic treatment.

    Two visits endodontic treatment

    Arm Description

    •single visit endodontic Treatment of necrotic teeth using Protaper next.

    •Two visits endodontic Treatment of necrotic teeth using Protaper next.

    Outcomes

    Primary Outcome Measures

    Change of post operative pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2016
    Last Updated
    December 6, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02984488
    Brief Title
    Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next
    Official Title
    Post-Obturation Pain Following One-visit Versus Two-visit Root Canal Treatment of Necrotic Anterior and Premolar Teeth Using Protaper Next
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the incidence and severity of postoperative pain after root canal therapy of necrotic teeth in one appointment versus two appointments using Protaper next instrument.
    Detailed Description
    The key to endodontic success was described as the debridement and neutralization of any tissue, bacteria, or inflammatory products within the root canal system. Endodontic treatment used to take multiple visits to complete, with one of the main reasons for this being that it required a considerable amount of time to complete the treatment. The single-visit treatment was bought back in the 1950s by Ferranti, who advocated the use of diathermy for pulpal disinfection and hydrogen peroxide for irrigation. The use of contemporary endodontic techniques and equipment, such as use of rubber dam, magnifying devices, electronic apex locators, engine-driven rotary nickel titanium files, and so forth, not only increases the success rate of endodontic treatment but also, shortens the time needed for the treatment. Endodontic treatment may therefore be completed in a single visit. It is generally agreed upon that the prepared canals can never be sterile before obturation, no matter how potent the antibacterial irrigants or intracanal medications are. There are currently two measures to reduce bacterial persistence and reinfection in the canals. We can either dress the canals with antibacterial agents in multiple visits or immediately obturate the canals, to reduce the space for bacterial colonization, in a single-visit approach. Calcium hydroxide is the most commonly used intracanal medicament, however its efficacy towards Enterococcus faecalis is questionable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth, Nonvital
    Keywords
    necrotic teeth, single visit, multiple visits, protaper next

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single visit endodontic treatment.
    Arm Type
    Experimental
    Arm Description
    •single visit endodontic Treatment of necrotic teeth using Protaper next.
    Arm Title
    Two visits endodontic treatment
    Arm Type
    Active Comparator
    Arm Description
    •Two visits endodontic Treatment of necrotic teeth using Protaper next.
    Intervention Type
    Procedure
    Intervention Name(s)
    single visits
    Intervention Description
    Endodontic treatment is done and completed in a single visit using protaper next rotary system.
    Intervention Type
    Procedure
    Intervention Name(s)
    two visits
    Intervention Description
    Endodontic treatment is done and completed in two visits using protaper next rotary system.
    Primary Outcome Measure Information:
    Title
    Change of post operative pain.
    Time Frame
    After 6-12-24-48 hours from the obturation step of the endodontic treatment.

    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: Medically free patients. Patient's age above 18 years old. Teeth diagnosed clinically with necrosis. Positive patient's acceptance for participation in the study. Sex includes both male and female. Patients who can understand visual analogue scale. Patients able to sign informed consent. Exclusion criteria: Pregnancy or lactation. Medically compromised patients. Patient with multiple teeth that required treatment in the same quadrant to eliminate the possibility of pain referral.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hebatallah M nada, student
    Phone
    o1112393619
    Email
    dr_heba_nada@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abeer sabi, lecturer
    Phone
    01001192266
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Saeed M Abd El aziz, professor
    Organizational Affiliation
    Department of endodontics - Faculty of Oral and Dental medicine - CU
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    hebatallah M nada, student
    Organizational Affiliation
    Department of endodontics - Faculty of Oral and Dental medicine - CU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24876699
    Citation
    Rao KN, Kandaswamy R, Umashetty G, Rathore VP, Hotkar C, Patil BS. Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth. J Int Oral Health. 2014 Apr;6(2):28-32. Epub 2014 Apr 26.
    Results Reference
    background
    PubMed Identifier
    12075212
    Citation
    DiRenzo A, Gresla T, Johnson BR, Rogers M, Tucker D, BeGole EA. Postoperative pain after 1- and 2-visit root canal therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):605-10. doi: 10.1067/moe.2002.121900.
    Results Reference
    background

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    Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next

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