Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments

January 24, 2024 updated by: Sıla Nur Usta, Saglik Bilimleri Universitesi

Evaluation of the Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments: a Randomized Clinical Trial

The goal of this clinical trial is to evaluate the expression of inflammatory mediators in the crevicular fluid and periodontal ligament after one-visit root canal treatment of mandibular molars of patients with asymptomatic irreversible pulpitis using 3 different file systems.

The main question it aims to answer is: Does conservative root canal preparation cause decreased expression of inflammatory mediators compared to conventional root canal preparation?

In this context, patients will be divided into 3 groups based on the file systems as follows: ProTaper Gold, OneShape, and TruNatomy up to apical size #25. Both inflammatory mediator expression and postoperative VAS values will be compared.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The below-mentioned steps will be performed in the scope of this study:

  1. Ethical approval has been obtained.
  2. The sample size calculation was performed (90% power, 0.597 effect size, 20 patients per group)
  3. Patients aged 18-60 with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination and without any systemic disease will be included.
  4. Only mandibular first and second molar teeth that do not have complex anatomy, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks will be included.
  5. Patients with acute symptoms, a history of taking analgesics 48 hours or antibiotics within 1 month prior to the visit, being pregnant and lactating, and having several periodontal problems will be excluded.

5) Immature apexes and trauma cases will also be excluded. 6) Selected patients will be informed about the study, and written consent will be obtained from all patients.

7) Patients will be randomly distributed into groups using a software (www.randomizer.org). Moreover, patients will be blinded regarding the file system they use.

8) A single operator will perform all endodontic treatments in the same clinical conditions.

9) Before starting the treatment, the baseline Visual Analogue Scale (VAS) values will be recorded.

10) For baseline inflammatory mediator assessment, gingival crevicular fluid samples from mesial and distal surfaces from teeth with #20 paper points for 30 seconds and paper points will be placed into Eppendorf tubes and kept at -80 ° until the analysis is performed.

11) After the administration of the local anaesthesia, teeth will be isolated with a rubber dam, and access cavities will be prepared. Then, teeth will be allotted to one of the following file systems:

  • Group 1 (ProTaper Gold file system): Sx-S1-S2-F1-F2 (for mesial canals), F3 (for distal canal)
  • Group 2 (OneShape file system): 25/.06 (for mesial canals), additional file for distal canal if needed.

  • Group 3 (TruNatomy file system): 17/.02, 20/.04 ve 26/.04 (for mesial canals), 36/.03 (for distal canal.)

    12) 2 mL 2.5% sodium hypochlorite (NaOCl) will be used between files and final irrigation will be performed using 5 mL NaOCL, 5 mL 17% ethylenediaminetetraacetic acid (EDTA), and 5 mL distilled water with 31-G side vented needle.

    13) After drying the canals, #15 paper point will be placed inside mesial canals for 1 minute, 2 mm beyond the apex. Afterwards, paper points will be placed into Eppendorf tubes and kept at -80 ° until the analysis is performed.

    14) Root canals will be obturated with resin-based sealer and gutta-percha. 15) Permanent restoration will be done using composite. 16) Patients will be recalled at 24 and 72 hours, and gingival crevicular fluid samples from mesial and distal surfaces will be obtained using an above-mentioned method.

    17) Measurement of postoperative pain after treatment with a VAS scale at 24, 48, and 72 hours will also be recorded.

    18) Measurement of pain mediators (Substance P, Prostaglandin E2, interleukin (IL) 6, and IL-10) will be performed with ELISA kits. All samples will be analyzed in duplicate.

    19) Based on the readings obtained from the spectrophotometer, results will be fitted to the standard curve and presented in the form of picograms per millilitre (pg/mL).

    20) Statistical analysis will be conducted.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18-60
  • Patients with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination
  • Patients with pain pain between 0 and 3 on the VAS scale
  • Patients without any systemic disease
  • Mandibular first and second molar teeth without complex root canal anatomy, calcifications, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks

Exclusion Criteria:

  • Patients with acute symptoms
  • Patients who have a history of taking analgesics 48 h or antibiotics within 1 month prior to the visit
  • Patients who are being pregnant and lactating
  • Patients with several periodontal problems
  • Patients with systemic disease
  • Teeth with immature root apexes
  • Trauma cases

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ProTaper Gold file system
Sx-S1-S2-F1-F2 files for mesial canals and F3 file for distal canal with 350 rpm speed and 2 Ncm torque will be used via an endodontic motor.
Procedure: ProTaper Gold file system
According to the manufacturers ' instructions, root canal treatments will be conducted with the ProTaper Gold rotary file system up to F2 for mesial canals.
Experimental: OneShape file system
25/.06 file for mesial canals with 350 rpm and 4 Ncm torque will be used via an endodontic motor.
Procedure: OneShape file system
According to the manufacturers ' instructions, root canal treatments will be conducted with the OneShape rotary file system up to 25/.06 for mesial canals.
Experimental: TruNatomy file system
17/.02, 20/.04 ve 26/.04 files for mesial canals and 36/.03 file for distal canal with 500 rpm speed and 1.5 Ncm torque will be used via an endodontic motor.
Procedure: TruNatomy file system
According to the manufacturers ' instructions, root canal treatments will be conducted with the TruNatomy rotary file system up to 26/.04 for mesial canals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Substance P
Time Frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Substance P
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin E2
Time Frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin E2
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Release of inflammatory mediators
Time Frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin IL-6
Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of IL-10
Time Frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of IL-10
Before root canal treatment (Day 0), at 24 hours, and at 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain assessment using visual analog scale
Time Frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Postoperative pain assessment using visual analog scale
Before root canal treatment (Day 0), at 24 hours, and at 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Study Director: Serpil Karaoğlanoğlu, Professor, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 15, 2024

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBU-GFOD-ENDO-SILANURUSTA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Within the scope of the necessity of protecting the individual information of the patients, it is considered that the recorded data will not be shared.

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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