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

Tooth,Non-vital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02912286
• Other study ID #: CEBD-CU-2016-09-200
• Status: Not yet recruiting
• Phase: N/A
• First received: September 20, 2016
• Last updated: September 22, 2016
• Start date: January 2017
• Est. completion date: May 2019

Study information

• Verified date: September 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: May 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Tooth, Nonvital
• Tooth,Non-vital

Intervention

Device:
• conventional needle irrigation
conventional side-vented syringe used to deliver irrigant in root canal treatment
• passive ultrasonic irrigation
ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment
• sonic irrigation
vibringe system is a sonic device that deliver and agitate the irrigant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No