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Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth

Primary Purpose

Dental Pulp Necroses

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
XP Endo Finsher as final step of the irrigation protocol
Conventional needle irrigation only
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Necroses

Eligibility Criteria

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

Inclusion Criteria:

i. Age between 18-50 years old. ii. Males or Females. iii. mandibular Premolars

  • Asymptomatic.
  • Non-vital response of pulp tissue (negative response).
  • With or without periapical radiolucency.

Exclusion Criteria:

i. Patients allergic to penicillin. ii. Pregnant females. iii. Patients having significant systemic disorder. iv. If antibiotics have been administrated during the past two weeks preoperatively.

v. Patients having bruxism or clenching. vi. Teeth that have :

  • Vital pulp tissues.
  • Association with swelling
  • Acute peri-apical abscess
  • Periodontally affected teeth
  • No possible restorability
  • Previous endodontic treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    XP Endo Finisher

    Conventional needle irrigation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Post-operative pain recorded by the patient using a four step pain scale (0-3)

    Secondary Outcome Measures

    Post-operative swelling
    Need\ number of Analgesic tablets
    Need for systemic antibiotics

    Full Information

    First Posted
    October 31, 2016
    Last Updated
    November 14, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02952326
    Brief Title
    Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
    Official Title
    Comparison Of The Effect of Adding XP Endo Finisher To The Irrigation Protocol Versus Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth
    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
    November 2017 (Anticipated)
    Study Completion Date
    January 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
    Comparing the postoperative flare ups and pain after adding the XP Endo Finisher to the final irrigation protocol on necrotic mandibular premolars.
    Detailed Description
    patients are randomized into 2 groups after meeting the eligibility criteria, Each patient will be given pain scale chart in order to record his /her pain level before any intervention. The tooth is anesthetized, accessed and mechanical instrumentation to be made 3 A) For the experimental group: The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation B) For the control group : The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. 4) Obturation is done and postoperative instructions are given to the patient

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pulp Necroses

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    XP Endo Finisher
    Arm Type
    Experimental
    Arm Title
    Conventional needle irrigation
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    XP Endo Finsher as final step of the irrigation protocol
    Intervention Description
    The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional needle irrigation only
    Intervention Description
    The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.
    Primary Outcome Measure Information:
    Title
    Post-operative pain recorded by the patient using a four step pain scale (0-3)
    Time Frame
    up to 5 days after the treatment
    Secondary Outcome Measure Information:
    Title
    Post-operative swelling
    Time Frame
    up to 5 days after the treatment
    Title
    Need\ number of Analgesic tablets
    Time Frame
    up to 5 days after the treatment
    Title
    Need for systemic antibiotics
    Time Frame
    up to 5 days after the treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: i. Age between 18-50 years old. ii. Males or Females. iii. mandibular Premolars Asymptomatic. Non-vital response of pulp tissue (negative response). With or without periapical radiolucency. Exclusion Criteria: i. Patients allergic to penicillin. ii. Pregnant females. iii. Patients having significant systemic disorder. iv. If antibiotics have been administrated during the past two weeks preoperatively. v. Patients having bruxism or clenching. vi. Teeth that have : Vital pulp tissues. Association with swelling Acute peri-apical abscess Periodontally affected teeth No possible restorability Previous endodontic treatment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27206916
    Citation
    Elnaghy AM, Mandorah A, Elsaka SE. Effectiveness of XP-endo Finisher, EndoActivator, and File agitation on debris and smear layer removal in curved root canals: a comparative study. Odontology. 2017 Apr;105(2):178-183. doi: 10.1007/s10266-016-0251-8. Epub 2016 May 20.
    Results Reference
    background
    PubMed Identifier
    12823700
    Citation
    Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. doi: 10.1046/j.1365-2591.2003.00671.x.
    Results Reference
    background

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    Comparing Between XP Endo Finisher and Conventional Irrigation Method On Post-Operative Flare Ups In Necrotic Teeth

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