- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05039502
Releasing of Inflammatory Mediators During Retreatment of Root Canals
September 2, 2021 updated by: Sevinç Aktemur Türker, Bulent Ecevit University
The Effect of Different File Systems Used in Retreatment on the Release of Inflammatory Mediators
Nonsurgical root canal retreatment may become essential when the initial endodontic treatment fails because of the persistent intracanal or extracanal infections.The aim of this thesis study is to evaluate the effect of ProTaper Universal Retreatment (PTUR), Reciproc blue and XP-endo Finisher R file systems, which are used in the removal of root canal filling materials during retreatment with different motion kinetics on the release of Substance P, Calcitonin Gene-Related Peptide (CGRP), IL-6 and IL-10 inflammatory mediators in the periapical region
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Seventy-five individuals with asymptomatic and chronic apical periodontitis teeth with retreatment indication were included in the study.
Individuals were randomly divided into three groups according to the file system used to remove root canal filling materials (n = 25): ProTaper Universal Retreatment, Reciproc blue and XP-endo Finisher R.After the removal of the previous root canal filling materials, reshaping and disinfection of the root canals, periapical fluid samples were taken from the root tip of the teeth in all three groups.
The amount of Substance P, CGRP, IL-6 and IL-10 mediators that cause pain, swelling and flare-up in periapical fluid samples were measured by ELISA test.
Study Type
Interventional
Enrollment (Actual)
75
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 Locations
-
-
-
Zonguldak, Turkey
- Faculty of Dentistry of Bulent Ecevit 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 68 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who had single root canal treated teeth with chronic periapical lesion
Exclusion Criteria:
- Patients who are immunocompromised
- Patients under antibiotic or analgesic medication
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: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Retreatment system using in rotational motion
Previous root canal filling materials were removed with D1-D2-D3 retreatment files with using an endodontic motor in rotational motion
|
D1-D2-D3 Retreatment files were used in 500 rpm and 3 Ncm with X-Smart endomotor
|
|
EXPERIMENTAL: Retreatment system using in reciprocal motion
Previous root canal filling materials were removed with Reciproc 25 file with using an endodontic motor in reciprocal motion
|
R25 retratment files were used with X-Smart endomotor in reciprocal motion
|
|
EXPERIMENTAL: Retreatment system using in additional rotational motion
Previous root canal filling materials were removed with XP-endo finisher r file with using an endodontic motor in rotational motion
|
XP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of inflammatory mediator level
Time Frame: 24 hours
|
The samples were collected from periapical exudate at the end of the root canal retreatment procedure.
The samples were analyzed with ELISA method and change of inflammatory mediator levels were evaluated in pg/ml.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sevinç Aktemur Türker, Bulent Ecevit 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)
October 1, 2020
Primary Completion (ACTUAL)
March 15, 2021
Study Completion (ACTUAL)
June 1, 2021
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
September 2, 2021
First Posted (ACTUAL)
September 9, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2020-27194235-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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