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

Postoperative Pain Following Irrigation With Endodontic Needle, Sonic and Passive Ultrasonic Techniques: A Randomized Controlled Trial

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 Overview

• Status: Unknown
• Conditions: Tooth,Non-vital
• Intervention / Treatment: Device: conventional needle irrigation; Device: passive ultrasonic irrigation; Device: sonic irrigation

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
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain measured by numerical rate scale	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.	4 hours after treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Tooth, Nonvital
• Other Study ID Numbers: CEBD-CU-2016-09-200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No