Inflammatory ResponseNCT05039502

Releasing of Inflammatory Mediators During Retreatment of Root Canals

A study testing Protaper Universal Retreatment, Reciproc and XP-Endo finisher R in people with Inflammatory Response and Root Canal Infection, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 68 yearsHealthy volunteers can take part
Conditions the study is for: Inflammatory Response, Root Canal Infection
What is being tested?: Protaper Universal Retreatment, Reciproc and XP-Endo finisher R
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2020to 1 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 68 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients who had single root canal treated teeth with chronic periapical lesion

Who cannot join

Patients who are immunocompromised
Patients under antibiotic or analgesic medication

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Faculty of Dentistry of Bulent Ecevit University
Zonguldak

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Conditions: Inflammatory Response, Root Canal Infection
Being tested: Protaper Universal Retreatment, Reciproc, XP-Endo finisher R

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Protaper Universal RetreatmentOther
D1-D2-D3 Retreatment files were used in 500 rpm and 3 Ncm with X-Smart endomotor
ReciprocOther
R25 retratment files were used with X-Smart endomotor in reciprocal motion
XP-Endo finisher ROther
XP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor

Study groups in NCT05039502
Study group	Role	What they receive
Retreatment system using in rotational motion	Experimental	Previous root canal filling materials were removed with D1-D2-D3 retreatment files with using an endodontic motor in rotational motion Receives: Other: Protaper Universal Retreatment
Retreatment system using in reciprocal motion	Experimental	Previous root canal filling materials were removed with Reciproc 25 file with using an endodontic motor in reciprocal motion Receives: Other: Reciproc
Retreatment system using in additional rotational motion	Experimental	Previous root canal filling materials were removed with XP-endo finisher r file with using an endodontic motor in rotational motion Receives: Other: XP-Endo finisher R

What is being measured

The primary outcome is the main question the study is designed to answer.

change of inflammatory mediator level
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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20201 Jun 2021

First posted9 Sep 2021
Study start1 Oct 2020
Primary completion15 Mar 2021
Study completion1 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05039502
Sponsor's protocol ID: 2020-27194235-01
Status last verified: Sep 2021
First submitted: 31 Aug 2021
Last updated: 9 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kasikci S, Turker SA, Guven B. Effect of different retreatment files using different kinematics on the release of inflammatory mediators in root canal retreatment of single-rooted teeth: a randomized clinical trial. Clin Oral Investig. 2023 Jun;27(6):3189-3196. doi: 10.1007/s00784-023-04930-6. Epub 2023 Mar 1.
PubMed 36856848

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Different File Systems Used in Retreatment on the Release of Inflammatory Mediators
ClinicalTrials.gov ID: NCT05039502
Acronym / sponsor ID: 2020-27194235-01
Conditions: Inflammatory Response, Root Canal Infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Bulent Ecevit UniversityUniversity, hospital or other
Study start: 1 Oct 2020 (actual)
Primary completion: 15 Mar 2021 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 9 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Retreatment system using in rotational motion	Experimental	Other: Protaper Universal RetreatmentPrevious root canal filling materials were removed with D1-D2-D3 retreatment files with using an endodontic motor in rotational motion
Retreatment system using in reciprocal motion	Experimental	Other: ReciprocPrevious root canal filling materials were removed with Reciproc 25 file with using an endodontic motor in reciprocal motion
Retreatment system using in additional rotational motion	Experimental	Other: XP-Endo finisher RPrevious root canal filling materials were removed with XP-endo finisher r file with using an endodontic motor in rotational motion

Who may qualify

Ages: 18 to 68 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who had single root canal treated teeth with chronic periapical lesion

Key exclusion criteria (2 listed)

Patients who are immunocompromised
Patients under antibiotic or analgesic medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Protaper Universal RetreatmentD1-D2-D3 Retreatment files were used in 500 rpm and 3 Ncm with X-Smart endomotor	Other	Retreatment system using in rotational motion
ReciprocR25 retratment files were used with X-Smart endomotor in reciprocal motion	Other	Retreatment system using in reciprocal motion
XP-Endo finisher RXP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor	Other	Retreatment system using in additional rotational motion

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Derived from this study: PubMed 36856848Kasikci S, Turker SA, Guven B. Effect of different retreatment files using different kinematics on the release of inflammatory mediators in root canal retreatment of single-rooted teeth: a randomized clinical trial. Clin Oral Investig. 2023 Jun;27(6):3189-3196. doi: 10.1007/s00784-023-04930-6. Epub 2023 Mar 1.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sevinç Aktemur Türker study director

Bulent Ecevit University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of inflammatory mediator level (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039502, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.