Comparing Efficacy of a Stainless-steel Rotary File with Two Nickel-titanium Systems on Periapical Lesion Healing

December 20, 2024 updated by: Beirut Arab University

Comparing the Efficacy of a Stainless-Steel Rotary File with Two Nickel-Titanium Systems on Periapical Lesion Healing Using Cone-Beam Computed Tomography

Background: This study used cone-beam computed tomography (CBCT) to compare a stainless-steel Tornado file system with OneShape and WaveOne rotary systems for biomechanical canal preparation as indicated by the healing of periapical lesions.

Methods: Lower molars with necrotic pulps and periapical lesions were arbitrarily divided into three groups (n=20) rendering to three rotary file systems. After root canal treatment, clinical and radiographic assessment of the apical radiolucency was evaluated at one year using pre- and post-instrumentation CBCT images. Statistical analysis was performed to compare the three systems at a p-value of 0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A sample size of 60 subjects (38 females and 22 males) was randomly selected for this randomized clinical research based on a power of 80%, and a significance level of 0.05. The patients should have lower molars with two separate mesial canals, distinct apical foramen, mature apices, and neither cracks nor resorption. Canal curvature for mesial canals ranged from 15° to 45°. The study excluded patients younger than 16 or older than 65, who had diabetes, immune-compromising conditions, or had previous dental work on the working tooth. We informed the patients about the potential risks, discomfort, and potential benefits. Patients who met the inclusion criteria signed a consent form. Table 1 shows the demographics of the study samples. Every patient was evaluated and reviewed through appropriate history taking, clinical examinations, and pre-operative digital radiography. The past dental and medical history, major complaints, and demographic data were recorded. Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size. The patients were then divided randomly into three equal groups (n = 20). After proper anesthesia and isolation, access cavities were completed with a round bur, followed by an Endo Z bur. Working length was determined using an apex locator (DENTA PORT ZX, Japan), and confirmed by periapical X-ray. Canal patency was established with a #15 K-type file (MANI, Vietnam) and RC prep glide path (Premier Dental, USA). Canals were prepared with the assigned instrumentation system according to the manufacturer's instructions and irrigated with 2 mm of a 2.5% sodium hypochlorite solution (NaOCl) (Clorox, Lebanon) followed by 3.0 mL of 17% ethylene-diamine-tetraacetic acid (EDTA) (NEXABIO, Korea) for 1 minute, and then 1.3% NaOCl as final irrigation. Tornado Finisher was used as directed by the manufacturer at 1 mm short of the working length in an up-and-down motion. In the other two groups, irrigation was performed with a 31G side-vented needle (Ultradent Products Inc.) placed passively into the canal, 1 mm short of the working length.Intracanal calcium hydroxide was added to the canals for one week. Every tooth in the three groups underwent the same obturation procedure (Lateral condensation technique) using gutta-percha (DiaDent, Korea) and sealer (META BIOMED, Korea). Finally, coronal preparation of all teeth was restored with composite filling (Ivoclar, Switzerland). Clinical evaluation was conducted at a one-year follow-up visit for each patient including spontaneous pain, sinus tract, swelling, mobility, periodontal probing depths greater than baseline, or sensitivity to percussion or palpation. A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion based on Estrela et al.CBCT periapical index (CBCT PAI). The radiolucent area of the periapical lesion was measured in three dimensions on the CBCT scan. Bucco-palatal, mesiodistal, and diagonal measurements were obtained, and the greatest diameter was recorded for scoring the lesion extension . Measurements were conducted simultaneously and independently by two examiners and any discrepancies were discussed and remeasured for one measurement agreement. Cortical bone expansion (E) and cortical bone destruction (D) were included in the scoring system as appropriate. If either of these conditions was found in the CBCT analysis, the variables E and D were added to each score. Qualitative analysis of clinical evaluations was conducted for signs and symptoms. The pre- and post-operative Estrela et al. index scores were recorded. The Statistical Package for the Social Sciences software (SPSS 22, SPSS Inc, Chicago, IL) was used to perform the statistical analysis. The median was used to describe the qualitative data for all groups and normal distribution was tested using Shapiro-Wilk test. Since the data did not follow a normal distribution, the scores of the size of the apical lesion before and after one year were done for each group using the Wilcoxon signed ranks test while inter-group comparison was done using the Kruskal Wallis test followed by Mann-Whitney test for comparison of pairs. All statistical tests were performed at a p-value of 0.05.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Lebanon
      • Beirut, Lebanon
        • College of dentistry, Beirut Arab University
      • Beirut, Lebanon
        • faculty of dentistry, Beirut Arab 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The patients should have lower molars with

  • Two separate mesial canals.
  • Distinct apical foramen.
  • Mature periapical apices.
  • No tooth cracks.
  • No root resorption.
  • Canal curvature for mesial canals ranged from 15° to 45°.

Exclusion Criteria:

  • Patient who is younger than 16 or older than 65.
  • Diabetic patient.
  • Immune-compromising conditions.
  • Patient has previous dental work on the working tooth.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE).
Root canal treatment was done using Stainless steel tornado rotary system
Device: Tornado rotary system
In arm one, stainless steel tornado files works by high-speed rotation that influences the fluid dynamics within the canal and improves irrigation efficiency. Canals are finished with a file having a 4% taper and an apical diameter of 0.25 mm.
Other Names:
  • Revolving SS Tornado rotary system (MIB, FRANCE) in arm one
Device: Cone beam computed tomography
A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion.
Other Names:
  • Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size.
Experimental: Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues,
Root canal treatment was done using WaveOne rotary system
Device: Cone beam computed tomography
A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion.
Other Names:
  • Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size.
Device: WaveOne rotary system
In arm two, WaveOne system is a single reciprocating file system with a heat-treated NiTi Memory Wire (M Wire).It has a taper of 0.08 in apical 3 mm, with a tip diameter of 0.25 mm. in a torque control endodontic handpiece (X smart plus with reciprocation mode)
Other Names:
  • In arm two, WaveOne single reciprocating file system
Experimental: The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France).
Root canal treatment was done using OneShape rotary system
Device: Cone beam computed tomography
A post-operative CBCT image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion.
Other Names:
  • Operating teeth were scanned with an axial slice thickness of 0.1 mm using a CBCT (Kodak 9000C) with an 80 kV, 4 mA, 51 × 51 mm field of view, and 0.1/voxel (mm) size.
Device: OneShape rotary system
In arm three, OneShape system utilizes a conventional, continuous rotational motion. It has asymmetric cross-sectional geometry, and traveling waves of motion that are produced along the file's active region. It has a single constant taper of 0.06 and a tip size of 25 with distinct cross-sectional designs along the whole length of the working parts
Other Names:
  • In arm three, OneShape rotary system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three-dimension lenght in millimeter for apical radiolucency in CBCT for each pateint
Time Frame: One-year follow-up visit for each pateint
A post-operative Cone beam computed tomography(CBCT) image was obtained and compared to the pre-operative one to assess the impact of canal preparation of each file on the periapical lesion based on Estrela et al CBCT periapical index (CBCT PAI). The radiolucent area of the periapical lesion was measured in millimeters for the three dimensions on the CBCT scan. Bucco-palatal, mesiodistal, and diagonal measurements were obtained, and the greatest diameter was recorded for scoring the lesion extension. Measurements were conducted simultaneously and independently by two examiners and any discrepancies were discussed and remeasured for one measurement agreement.
One-year follow-up visit for each pateint

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative scoring for clinical criteria for each pateint
Time Frame: One-year follow-up visit for each pateint.
The scoring description was collected for clinical criteria. The scoring was for the presence or absence of spontaneous pain, sinus tract, swelling, tooth mobility, sensitivity to percussion or palpation and the depth of periodontal probing in millimeter greater than preoperative baseline. Scoring was done for each item using scales according to published previous research in the literature.
One-year follow-up visit for each pateint.

Collaborators and Investigators

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

Sponsor

Beirut Arab University

Investigators

  • Principal Investigator: alaa eldeen O Mais, PhD, Beirut Arab University

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 (Actual)

April 6, 2018

Primary Completion (Actual)

March 8, 2022

Study Completion (Actual)

January 9, 2023

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-H-0056-D-P-0457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD can't be shared due to ethical issues. IPD of this study is confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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