Releasing of Inflammatory Mediators During Retreatment of Root Canals

Sponsor

Bulent Ecevit University (Other)

Overall Status

Completed

CT.gov ID

NCT05039502

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Response Root Canal Infection	Other: Protaper Universal Retreatment Other: Reciproc Other: XP-Endo finisher R	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Effect of Different File Systems Used in Retreatment on the Release of Inflammatory Mediators

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Mar 15, 2021

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

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	Other: Protaper Universal Retreatment 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	Other: Reciproc 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	Other: XP-Endo finisher R XP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor

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

Other: Protaper Universal Retreatment

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

Other: Reciproc

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

Other: XP-Endo finisher R

XP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor

Outcome Measures

Primary Outcome Measures

change of inflammatory mediator level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry of Bulent Ecevit University	Zonguldak		Turkey

Sponsors and Collaborators

Bulent Ecevit University

Investigators

Study Director: Sevinç Aktemur Türker, Bulent Ecevit University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sevinç Aktemur Türker, Associate Professor, Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT05039502

Other Study ID Numbers:

2020-27194235-01

First Posted:

Sep 9, 2021

Last Update Posted:

Sep 9, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 9, 2021