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Post Operative Pain of Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis

Primary Purpose

Pulpitis - Irreversible

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

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring irreversible pulpitis, reciprocation, rotation, single file, wave one, neolix

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients in good health(American Society of Anesthesiologists Class II or higher).
  2. Patients having symptomatic irreversible pulpitis in one of their mandibular premolars.
  3. Age range is between 20 and 35 years.
  4. Patients who can understand numerical rating scale (NRS).
  5. Patients able to sign informed consent.

Exclusion Criteria:

  1. Patients with positive percussion test .
  2. Patients having history of necrosis with or without apical pathosis .
  3. Patients have sinus tract or fistula extraoral or intraoral.
  4. Patients having active pain in more than one pre molar.
  5. Patients who had taken analgesics in the 12 hours preceding the preparation.
  6. Pregnant or mentally retarded patients.
  7. Teeth with grade 2 or 3 mobility.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    neolix

    wave one

    Arm Description

    single full rotation file (Neolix ® Neolix ,France) the 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 Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length of the canal

    single reciprocating file (Wave One ® Dentsply , Switzerland) the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length of the canal

    Outcomes

    Primary Outcome Measures

    postoperative pain
    intensity of postoperative pain after treatment by Numerical Rating Scale (0-10)

    Secondary Outcome Measures

    Full Information

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

    Unique Protocol Identification Number
    NCT02952300
    Brief Title
    Post Operative Pain of Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis
    Official Title
    Comparative Evaluation of Postoperative Pain After Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis of Mandibular Premolar Teeth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    October 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
    the aim in this prospective in vivo randomized clinical trial to evaluate the influence of instrumentation technique ( reciprocation single file (wave one ) versus rotation single file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic treatment in single rooted lower premolars with symptomatic irreversible pulpits. According to the inclusion criteria the patients enrolled in the study and allocated randomly into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is done at single visit. firstly the patient's medical and dental history is taken .the patient assign on informed consent. and then,anaesthetized and access cavity performed and root canal preparation is done by either two systems and then irrigation and obturation is done. the patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator will recall the patient to check the records and follow up the patient.
    Detailed Description
    Medical and dental history: diagnostic charts will be collected in a case report form by the investigators and confirmed for eligibility with the assistant supervisor. Radiographic examination : preoperative radiographs will be taken to examine the tooth structure,caries detection , periapical status . Clinical examination : intraoral examination include visual examination for caries , restoration ,swelling ,fistula . mobility, percussion were done . Diagnostic criteria for symptomatic irreversible pulpitis: The patient marks moderate to severe pain on the numerical rating scale (NRS) . a horizontal line of 11 marks and 10 intervals each takes numbers from 0 to 10 where 0 = no pain , 1-3 =mild pain , 4-6 = moderate pain , 7-10 = severe pain (recording the baseline degree of pain preoperatively before initiating the endodontic treatment ) all the steps done by the same operator. The patient shows severe pain which lasts long after thermal testing which is done by applying hot compound stick on the tooth after coating it with a lubricant. The patient responds to electric pulp tester at a lower level than the contralateral tooth or the adjacent tooth if the contralateral one is missing. Intervention: Forty four patients will included and they will be randomly divided into two groups A =root canal preparation with single reciprocating file (Wave One ® Dentsply , Switzerland) and B = Root canal preparation with single full rotation file (Neolix ® Neolix ,France) each group consisted from 22 patient . Procedure steps : Patients are asked to rate their pain level on numerical rating scale before the anesthesia injection and the start of the preparation to get the baseline record for the pain preoperatively . The patient will receive inferior alveolar nerve block injections ( 1.8 ml mepivacaine hydrochloride 2% ( 1: 100,000 epinephrine ) using a side loading aspirating syringe and 27-gauge long needle. At 15-minutes post injection, access cavity is performed using round bur size 4 and endo-z bur. Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity . Checking the patency of the canal with K- file (Mani Inc., Japan). size 10 taper 0.02, extirpation of pulp with H-file (Mani Inc., Japan). size 15 taper 0.02 . An electronic apex locator ( Morita Corporation, Kyoto, Japan) will be used to determine working length, and then working length will be confirmed radiographically to be adjusted 1mm shorter that the root apex. Each patient has equal chance to enter either the intervention groups A or B group as each patient takes number in excel sheet divided into two groups A and B chosen by assistant supervisor who determine which system will be used with this patient . Comparator group: If the system to by used is Wave One the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length with pre programmed motor (X-Smart Plus (Dentsply) with reducing hand piece 6:1 more anticlockwise angle than clock wise one . Experimental group : If the Neolix systems will be used ,then the 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 Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) 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 Plus motor with speed 300-500 rpm and torque 1.5 N.cm. Irrigation is made between each file using 2.5% sodium hypochlorite and MD-ChelCream19% ethylenediaminetetraacetic acid cream (METABIOMED company , Korea). The canals are then dried with paper points and obturated with gutta percha and ADSEAL resin sealer(METABIOMED company, Korea) by selection of a master cone corresponding to the size of master apical file, then spreader will be selected to provide auxiliary cones using cold lateral compaction technique. Access cavity is then sealed with temporary filling. then rating of post operative pain after the treatment is recorded by numerical rating scale ( NRS) in sheet given to the patient to record the degree of pain after 6 hrs ,12 hrs ,24 hrs ,48 hrs together with recalling the patient to check the record then the patient return the sheet to the operator and then the collected sheets presented to assistant supervisor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis - Irreversible
    Keywords
    irreversible pulpitis, reciprocation, rotation, single file, wave one, neolix

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    neolix
    Arm Type
    Experimental
    Arm Description
    single full rotation file (Neolix ® Neolix ,France) the 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 Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length of the canal
    Arm Title
    wave one
    Arm Type
    Active Comparator
    Arm Description
    single reciprocating file (Wave One ® Dentsply , Switzerland) the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length of the canal
    Intervention Type
    Procedure
    Intervention Name(s)
    neolix
    Intervention Description
    single rotation file
    Intervention Type
    Procedure
    Intervention Name(s)
    wave one
    Intervention Description
    single reciprocation file
    Primary Outcome Measure Information:
    Title
    postoperative pain
    Description
    intensity of postoperative pain after treatment by Numerical Rating Scale (0-10)
    Time Frame
    up to 48 hours after completion of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients in good health(American Society of Anesthesiologists Class II or higher). Patients having symptomatic irreversible pulpitis in one of their mandibular premolars. Age range is between 20 and 35 years. Patients who can understand numerical rating scale (NRS). Patients able to sign informed consent. Exclusion Criteria: Patients with positive percussion test . Patients having history of necrosis with or without apical pathosis . Patients have sinus tract or fistula extraoral or intraoral. Patients having active pain in more than one pre molar. Patients who had taken analgesics in the 12 hours preceding the preparation. Pregnant or mentally retarded patients. Teeth with grade 2 or 3 mobility.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yasmin hassan yousief, resident
    Phone
    01146326683
    Email
    dr.yasmien90@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    alaa elbaz, ass. professor
    Phone
    01000826286
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    abeer marouzk, professor
    Organizational Affiliation
    faculty of oral and dental medicine -cairo university
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    alaa el baz, ass. professor
    Organizational Affiliation
    faculty of oral and dental medicine -cairo university
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    yasmin hassan yousief, resident
    Organizational Affiliation
    faculty of oral and dental medicine -cairo university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17956561
    Citation
    Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
    Results Reference
    background
    PubMed Identifier
    16448929
    Citation
    Tanalp J, Kaptan F, Sert S, Kayahan B, Bayirl G. Quantitative evaluation of the amount of apically extruded debris using 3 different rotary instrumentation systems. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):250-7. doi: 10.1016/j.tripleo.2005.03.002. Epub 2005 Oct 14.
    Results Reference
    background
    PubMed Identifier
    14606784
    Citation
    Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.
    Results Reference
    background
    PubMed Identifier
    19748294
    Citation
    Pochapski MT, Santos FA, de Andrade ED, Sydney GB. Effect of pretreatment dexamethasone on postendodontic pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):790-5. doi: 10.1016/j.tripleo.2009.05.014. Epub 2009 Sep 12.
    Results Reference
    background
    PubMed Identifier
    19826598
    Citation
    Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009 Oct;3(4):273-9.
    Results Reference
    background
    PubMed Identifier
    21419285
    Citation
    Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
    Results Reference
    background

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    Post Operative Pain of Root Canal Preparation With Wave One and Neolix in Acute Irreversible Pulpitis

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