- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02912286
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: conventional needle irrigation
side-vented needle used for endodontic 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
|
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
|
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
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.
|
4 hours after treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2016-09-200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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