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Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Max-i-Probe
NaviTip
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Symptomatic Irreversible Pulpitis

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 16-65 year old.
  2. Medically free.
  3. Mandibular posterior teeth with symptomatic irreversible pulpitis.
  4. No sex predilection

Exclusion Criteria:

  1. Pregnant females.
  2. History of allergy to any medication used in the study.
  3. Preoperative premedication less than 6 hours before procedure.
  4. Cracked teeth and teeth with badly-decayed crowns.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Max-i-Probe

    NaviTip

    Arm Description

    Outcomes

    Primary Outcome Measures

    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment
    Postoperative pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2019
    Last Updated
    October 6, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04119661
    Brief Title
    Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
    Official Title
    Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (Actual)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    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
    The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.
    Detailed Description
    The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptomatic Irreversible Pulpitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Max-i-Probe
    Arm Type
    Experimental
    Arm Title
    NaviTip
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Max-i-Probe
    Intervention Description
    Using Max-i-Probe as endodontic needle during syringe irrigation
    Intervention Type
    Device
    Intervention Name(s)
    NaviTip
    Intervention Description
    Using NaviTip as endodontic needle during syringe irrigation
    Primary Outcome Measure Information:
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment
    Time Frame
    4 hours
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment
    Time Frame
    12 hours
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment
    Time Frame
    24 hours
    Title
    Postoperative pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 16-65 year old. Medically free. Mandibular posterior teeth with symptomatic irreversible pulpitis. No sex predilection Exclusion Criteria: Pregnant females. History of allergy to any medication used in the study. Preoperative premedication less than 6 hours before procedure. Cracked teeth and teeth with badly-decayed crowns.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suzan Amin, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohamed El-Bayoumi, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20647083
    Citation
    Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
    Results Reference
    background
    PubMed Identifier
    27248848
    Citation
    Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
    Results Reference
    background

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    Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles

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