NCT05039502

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

August 31, 2021

Last Update Submit

September 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Study Arms (3)

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

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

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

Other: XP-Endo finisher R

Interventions

D1-D2-D3 Retreatment files were used in 500 rpm and 3 Ncm with X-Smart endomotor

Retreatment system using in rotational motion

R25 retratment files were used with X-Smart endomotor in reciprocal motion

Retreatment system using in reciprocal motion

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

Retreatment system using in additional rotational motion

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who are immunocompromised
  • Patients under antibiotic or analgesic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry of Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Officials

  • Sevinç Aktemur Türker

    Bulent Ecevit University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 9, 2021

Study Start

October 1, 2020

Primary Completion

March 15, 2021

Study Completion

June 1, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations