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

NCT06752837 | Completed DMC FDA Device

• 1 other identifier: 2017-H-0056-D-P-0457
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Periapical Diseases; Root Canal Infection

Keywords

CBCT; Nickel-titanium files; Tornado rotary system

Outcome Measures

Primary Outcomes (1)

• Three-dimension lenght in millimeter for apical radiolucency in CBCT 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 Outcomes (1)

• Qualitative scoring for clinical criteria for each pateint

  One-year follow-up visit for each pateint.

Study Arms (3)

The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE).

EXPERIMENTAL

Root canal treatment was done using Stainless steel tornado rotary system

Device: Tornado rotary system; Device: Cone beam computed tomography

Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues,

EXPERIMENTAL

Root canal treatment was done using WaveOne rotary system

Device: WaveOne rotary system; Device: Cone beam computed tomography

The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France).

EXPERIMENTAL

Root canal treatment was done using OneShape rotary system

Device: OneShape rotary system; Device: Cone beam computed tomography

Interventions

Tornado rotary system DEVICE

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.

Also known as: Revolving SS Tornado rotary system (MIB, FRANCE) in arm one

The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE).

WaveOne rotary system DEVICE

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)

Also known as: In arm two, WaveOne single reciprocating file system

Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues,

OneShape rotary system DEVICE

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

Also known as: In arm three, OneShape rotary system

The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France).

Cone beam computed tomography DEVICE

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.

Also known as: 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.

Instrumentation was done using a reciprocating Ni-Ti WaveOne system (Dentsply Maillefer, Ballaigues,; The instrumentation was done using a revolving SS Tornado rotary system (MIB, FRANCE).; The instrumentation was done using a rotative Ni-Ti OneShape system (Micro Mége, Besançon, France).

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°.

You may not qualify if:

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

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (2)

College of dentistry, Beirut Arab University

Beirut, Lebanon

Location

faculty of dentistry, Beirut Arab University

Beirut, Lebanon

Location

Related Publications (6)

• Dorasani G, Madhusudhana K, Chinni SK. Clinical and radiographic evaluation of single-visit and multi-visit endodontic treatment of teeth with periapical pathology: An in vivo study. J Conserv Dent. 2013 Nov;16(6):484-8. doi: 10.4103/0972-0707.120933.

  PMID: 24347878 BACKGROUND

• De-Deus G, Souza EM, Barino B, Maia J, Zamolyi RQ, Reis C, Kfir A. The self-adjusting file optimizes debridement quality in oval-shaped root canals. J Endod. 2011 May;37(5):701-5. doi: 10.1016/j.joen.2011.02.001. Epub 2011 Mar 23.

  PMID: 21496675 BACKGROUND

• Patel S, Brown J, Pimentel T, Kelly RD, Abella F, Durack C. Cone beam computed tomography in Endodontics - a review of the literature. Int Endod J. 2019 Aug;52(8):1138-1152. doi: 10.1111/iej.13115. Epub 2019 Apr 9.

  PMID: 30868610 BACKGROUND

• Estrela C, Bueno MR, Azevedo BC, Azevedo JR, Pecora JD. A new periapical index based on cone beam computed tomography. J Endod. 2008 Nov;34(11):1325-1331. doi: 10.1016/j.joen.2008.08.013. Epub 2008 Sep 17.

  PMID: 18928840 BACKGROUND

• Moreinos D, Dakar A, Stone NJ, Moshonov J. Evaluation of Time to Fracture and Vertical Forces Applied by a Novel Gentlefile System for Root Canal Preparation in Simulated Root Canals. J Endod. 2016 Mar;42(3):505-8. doi: 10.1016/j.joen.2015.12.023. Epub 2016 Jan 28.

  PMID: 26831050 BACKGROUND

• Mais AO, Abdallah AM, Osman E, Alhadainy HA. Cone-Beam Computed Tomographic Evaluation of Periapical Lesion Healing After Root Canal Preparation with Different File Systems. Bioengineering (Basel). 2025 Nov 19;12(11):1267. doi: 10.3390/bioengineering12111267.

  PMID: 41301223 DERIVED

MeSH Terms

Conditions

Periapical Diseases

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Officials

• alaa eldeen O Mais, PhD

  Beirut Arab University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 31, 2024
• Study Start: April 6, 2018
• Primary Completion: March 8, 2022
• Study Completion: January 9, 2023
• Last Updated: December 31, 2024

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (2)