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

NCT ID: NCT02912286

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-05-31

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.

Conditions

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Tooth,Non-vital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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conventional needle irrigation

side-vented needle used for endodontic irrigation

Group Type ACTIVE_COMPARATOR

conventional needle irrigation

Intervention Type DEVICE

conventional side-vented syringe used to deliver irrigant in root canal treatment

passive ultrasonic irrigation

IrriSafe ultrasonic tip used for irrigation agitation in endodontic treatment

Group Type EXPERIMENTAL

passive ultrasonic irrigation

Intervention Type DEVICE

ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment

sonic irrigation

Vibringe is a sonic irrigation system used to irrigate and activate the irrigant at same time

Group Type EXPERIMENTAL

sonic irrigation

Intervention Type DEVICE

vibringe system is a sonic device that deliver and agitate the irrigant

Interventions

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conventional needle irrigation

conventional side-vented syringe used to deliver irrigant in root canal treatment

Intervention Type DEVICE

passive ultrasonic irrigation

ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment

Intervention Type DEVICE

sonic irrigation

vibringe system is a sonic device that deliver and agitate the irrigant

Intervention Type DEVICE

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nancy Samy

Assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CEBD-CU-2016-09-200

Identifier Type: -

Identifier Source: org_study_id

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