Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain

May 17, 2023 updated by: Yara Fawzy Kotb Elgazzar, Tanta University

Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth Into Root Canals and on Post-Operative Pain After Single-Visit Endodontic Treatment

Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

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

      • Tanta, Egypt
        • Faculty of Dentistry, Tanta 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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Asymptomatic vital/non vital teeth requiring root canal treatment.
  • Teeth with sound periodontal apparatus.
  • Teeth without pus or inflammatory exudates draining through the canal.
  • Teeth without anatomic variations.
  • Teeth with sinus tract.
  • Teeth without history of trauma.
  • Patients not on analgesics or sedative medication prior to root canal therapy

Exclusion Criteria:

  • • Patients with any systemic diseases.

    • Pregnant or lactating patients.
    • Immunocompromised patients.
    • Apparently thin roots in which apical preparation with #40 file would be overzealous.
    • Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
    • Teeth with calcified canals.
    • Patients with acute apical periodontitis, acute apical abscess, and weeping canals.
    • Necrotic painful teeth with the absence of sinus tract for drainage.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: xp endo finisher file
irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation
Other: new sonic EDDY system
irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation
Other: syringe needle irrigation
irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
irrigant penetration depth
Time Frame: through study completion, an average of 3 months
measurement of irrigant penetration depth using radioaque media and digital radiography
through study completion, an average of 3 months
postoperative pain
Time Frame: through study completion, an average of 3 months
evaluation of postoperative pain using visual analog scale VAS with scores from 0 to 100. score 0 indicated no pain while score 100 indicates maximum pain
through study completion, an average of 3 months

Collaborators and Investigators

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

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)

August 1, 2022

Primary Completion (Actual)

November 12, 2022

Study Completion (Actual)

November 25, 2022

Study Registration Dates

First Submitted

June 18, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Elgazzar YF1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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