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

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.

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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