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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tooth,Non-vital

Intervention / Treatment
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* Device: conventional needle irrigation
* Device: passive ultrasonic irrigation
* Device: sonic irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional needle irrigation<br>side-vented needle used for endodontic irrigation | Device: conventional needle irrigation<br>* conventional side-vented syringe used to deliver irrigant in root canal treatment<br>|
| Experimental: passive ultrasonic irrigation<br>IrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment | Device: passive ultrasonic irrigation<br>* ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment<br>|
| Experimental: sonic irrigation<br>Vibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time | Device: sonic irrigation<br>* vibringe system is a sonic device that deliver and agitate the irrigant<br>|

What is the study measuring?
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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 |