Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques

August 24, 2024 updated by: Ain Shams University

Correlation Between Postoperative Pain and Apical Extrusion of Different Irrigation Activation Techniques (Randomized Controlled Trial - an In Vitro Study)

The aim of this clinical trial is :

To evaluate effect of different techniques of irrigant activation:

  1. LASER activation
  2. sonic activation
  3. ultrasonic activation
  4. passive needle irrigation

On:

  1. Postoperative pain in vital teeth (Randomized controlled trial)
  2. Amount of apical extrusion (In vitro study) Participants will describe their preoperative pain and postoperative pain level at fixed time interval Research will compare postoperative pain accompanied with different irrigant activation techniques and correlate it to amount of debris extrusion

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age group 18-50 years
  • Males and females
  • Lower molars with symptomatic irreversible pulpitis without apical periodontitis

Exclusion Criteria:

  • Patients with uncontrolled health conditions
  • Immunocompromised patients
  • Teeth with periodontal diseases
  • Teeth with calcified canals
  • pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sonic activation
Device: sonic activator
Polyamide EDDY tips 28mm long is inserted in the canal 2mm short of the working length operated at 6,000 Hz. Activation is done for three cycles each for 20sec. The tip is moved vertically in up and down motion, 1ml is used for each activation cycle followed by 2ml 17% EDTA20
Experimental: LASER activation
Device: LASER activation
Diode laser 980nm is used to activate the irrigant using fiber optic tip of (200micrometer) and power of 1.5w continuous mode. The tip is placed 2 mm shorter than the working length. Laser irradiation is done for each canal for 20 secs repeated over three cycles for total time of 60 secs and 10 secs pauses between each cycle
Experimental: Ultrasonic activation
Device: Ultrasonic activation
ED60tip is used with ultrasonic device operated on mode E and inserted in the canal 2mm short of the working. Activation is done for three cycles each for 20 sec. The tip is moved vertically in up and down motion,1ml is used for each activation cycle followed by 2ml 17% EDTA
Active Comparator: passive irrigation with Endodontic needle
Device: passive irrigation with Endodontic needle
Each canal is irrigated with side vented endodontic needle 30G Placed 2mm short of the working length with total time of 60 secs followed by 2ml 17% EDTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of postoperative pain
Time Frame: 8,24,48 hours and one week
visual analogue scale
8,24,48 hours and one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of analgesic intake
Time Frame: 8,24,48 hours and one week
number of tablets
8,24,48 hours and one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

August 24, 2024

First Submitted That Met QC Criteria

August 24, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinShams Uni Endodontics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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