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Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques

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ClinicalTrials.gov Identifier: NCT02912286
Recruitment Status : Not yet recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Nancy Samy, Cairo University

Brief Summary:
The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

Condition or disease Intervention/treatment Phase
Tooth,Non-vital Device: conventional needle irrigation Device: passive ultrasonic irrigation Device: sonic irrigation Not Applicable

Detailed Description:

Different irrigation delivery systems are introduced to the market aiming to improve root canals disinfection. The conventional endodontic needle is commonly used because of its ease in use and good control of needle depth and irrigant volume. However it carries a higher risk of extruding the solution periapically because of positive pressure used in solution delivery.

Passive ultrasonic irrigation is a noncutting irrigation technique that is done with ultrasonically activated files with continuous or intermittent flow of irrigant. It was shown that it is effective in removing remnants of pulp tissue, dentin debris and planktonic bacteria.

The vibringe (Cavex Holland BV, Haarlem, the Netherlands) is an irrigation device that combines manual delivery and sonic activation of the irrigant.

The aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques: A Randomized Controlled Trial
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: conventional needle irrigation
side-vented needle used for endodontic irrigation
Device: conventional needle irrigation
conventional side-vented syringe used to deliver irrigant in root canal treatment

Experimental: passive ultrasonic irrigation
IrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment
Device: passive ultrasonic irrigation
ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment

Experimental: sonic irrigation
Vibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time
Device: sonic irrigation
vibringe system is a sonic device that deliver and agitate the irrigant




Primary Outcome Measures :
  1. postoperative pain measured by numerical rate scale [ Time Frame: 4 hours after treatment ]
    Numerical rate scale (NRS) consists of a line graded from 0-10 where 0 indicates no pain and 10 indicates worst pain, patient will choose the number that describe his pain level.



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or Females
  • Age between 16-60 years old
  • Permanent Mandibular molars with:

    • Non-vital response of pulp tissue
    • Absence of spontaneous pain

Exclusion Criteria:

  • Pregnant females
  • Patients having significant systemic disorder
  • Patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours
  • Teeth that have:

    • Vital pulp tissues
    • Association with swelling or fistulous tract
    • Acute periapical abscess
    • Greater than grade I mobility
    • Pocket depth greater than 5mm
    • Previous endodontic treatment

Responsible Party: Nancy Samy, Assisstant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02912286     History of Changes
Other Study ID Numbers: CEBD-CU-2016-09-200
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pain, Postoperative
Tooth, Nonvital
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases