- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05450003
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
Status
Completed
Conditions
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
- Name: yara fawzy kotb Elgazzar, B.D.S (2016)
- Phone Number: +02 01113674317
- Email: yara.fawzy@dent.tanta.edu.eg
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.
Sponsor
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
Additional Relevant MeSH Terms
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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