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Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone

Primary Purpose

Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
neolix rotary system (continuous rotation system)
waveone rotary system (reciprocating system)
hand files k-files
Sponsored by
Zahedan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms focused on measuring Instrumentation Post-operative pain Root canal preparation

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age range 20-50 years,
  • the systemically healthy,
  • first or second molar teeth require root canal therapy,
  • irreversible Pulpitis signed without the apical,
  • root canal curvature of less than 25 degrees, according to Schneider techniques.

Exclusion Criteria:

  • Root canal treatment,
  • history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment,
  • pregnancy,
  • complex anatomy,
  • channels blocked in the x-ray plate,
  • internal and external resorption,
  • open apex teeth,
  • periodontal disease,
  • inflammation and abscesses,
  • sinus tract,
  • presence of radiographic lesions,
  • tooth sensitivity to percussion,
  • absence of occlusal contact.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    neolix rotary system (continuous rotation system)

    waveone rotary system (reciprocating system)

    hand files k-files

    Arm Description

    Procedure: neolix rotary system post-treatment pain after using neolix rotary system

    Procedure: waveone rotary system post-treatment pain after using waveone rotary system

    Procedure: hand files post-treatment pain after using hand files

    Outcomes

    Primary Outcome Measures

    Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale

    Secondary Outcome Measures

    Full Information

    First Posted
    May 9, 2016
    Last Updated
    May 10, 2016
    Sponsor
    Zahedan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02768311
    Brief Title
    Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
    Official Title
    Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zahedan University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after endodontic treatments.
    Detailed Description
    Many studies of pain after root canal treatment experience were taken into consideration. Pain after endodontic treatment is still one of the major problems of patients. The prevalence that widely studied as 6/10% to 9.82% have been reported. One of the important strategies in endodontic treatment, prevention and control of pain after treatment. This multi-factorial disorder resulting in a complex process occurs, which affects the patient's intrinsic factors, the tooth and the dentist's skill. Mechanical factors include channel instrumentation techniques, over instrumentation or filling material extrusion channels associated with the presence of pain after treatment were considered. Apical extrusion of infected debris during instrumentation channel can create or exacerbate inflammatory process. Channel shaping the apical debris extrusion process can increase even if the preparation is limited to the channel. Leaving debris in both methods of preparation, either manually with stainless steel files and rotary technique with nickel titanium files happen. The use of rotary technique among dentists has increased. developing of NITI files and rotary instrumentation system, reduce apical extrusion of debris, so can be expected to reduce the incidence of inflammation and pain after treatment, achieved by these means. Recent studies have shown that reciprocal shaping techniques, compared with full-rotation techniques, significantly increased the amount of debris extruded from the apical region of the root are causing increasing pain after treatment. Two rotary system available on the market are: 1) Neolix (france Neolix SAS) recently introduced the file NITI, single file, with full rotation movements, with square and rectangular cross-section, with a non-uniform shape along the blade, tip sizes, 25 and Tipper 0 / 08, and a system, Wave one, (DENTSPLY Maillefer), which is a file NITI, Single file and Single use, and the reciprocation movements, and cross-Convex triangular Modified and in three sizes: small, primary (tip size 25 and Tipper 0/08), large is contained, which according to the size of the canal, one of them is selected. In a study by Ana Arias et al., Patients in the experimental group by the Rotary Files roots were treated and patients in control group were treated by the step-back technique, the results showed that more patients in the control group, experienced pain after root canal therapy. While the duration of the pain in the control group comparison to the experimental group, less has been reported. In a study by Aqrabawi, teeth with vital pulp were divided into two groups. Root canal therapy in the first group, was done by manual file, and the second group, by Protaper rotary files were performed. And no significant difference in pain after root canal treatment has not been detected. Gambarini was shown in the study, patients treated by waveone system they have done, significantly more pain after treatment compared to TF and TF adaptive experienced. Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after endodontic treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms
    Keywords
    Instrumentation Post-operative pain Root canal preparation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    neolix rotary system (continuous rotation system)
    Arm Type
    Experimental
    Arm Description
    Procedure: neolix rotary system post-treatment pain after using neolix rotary system
    Arm Title
    waveone rotary system (reciprocating system)
    Arm Type
    Experimental
    Arm Description
    Procedure: waveone rotary system post-treatment pain after using waveone rotary system
    Arm Title
    hand files k-files
    Arm Type
    Experimental
    Arm Description
    Procedure: hand files post-treatment pain after using hand files
    Intervention Type
    Procedure
    Intervention Name(s)
    neolix rotary system (continuous rotation system)
    Intervention Description
    Procedure: neolix rotary system
    Intervention Type
    Procedure
    Intervention Name(s)
    waveone rotary system (reciprocating system)
    Intervention Description
    Procedure: waveone rotary system
    Intervention Type
    Procedure
    Intervention Name(s)
    hand files k-files
    Intervention Description
    Procedure: hand files k-files
    Primary Outcome Measure Information:
    Title
    Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale
    Time Frame
    12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age range 20-50 years, the systemically healthy, first or second molar teeth require root canal therapy, irreversible Pulpitis signed without the apical, root canal curvature of less than 25 degrees, according to Schneider techniques. Exclusion Criteria: Root canal treatment, history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment, pregnancy, complex anatomy, channels blocked in the x-ray plate, internal and external resorption, open apex teeth, periodontal disease, inflammation and abscesses, sinus tract, presence of radiographic lesions, tooth sensitivity to percussion, absence of occlusal contact.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone

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