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

NCT06752837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-31

No results posted yet for this study

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

Interventions

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.

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)

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

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.

Sponsors & Collaborators

  • Beirut Arab University

    lead OTHER

Principal Investigators

  • alaa eldeen O Mais, PhD · Beirut Arab University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2022-03-08
Completion
2023-01-09
FDA Device
Yes

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06752837 on ClinicalTrials.gov