Simultaneous Working Length Detection Methods

NCT ID: NCT06507982

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-03-01

Brief Summary

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Precise knowledge of the apical construction, which determines the end of the area for canal preparation and filling, is essential for the success of root canal treatment and the management of postoperative pain. For this purpose, devices based on various methods that determine the working length are used. However, it is still controversial which method provides the most accurate measurements.In this study, the compatibility of the electronic apex locator (EAL) and simultaneous working length determination (SWL) methods in single-root teeth was investigated in comparison with the radiographic working length determination method (RWL) method, and to determine which one produced more effective results in terms of postoperative pain.A hundred patients applied for endodontic treatment with a diagnosis of irreversible pulpitis (IP) were included in the study, which was planned as a single-center prospective cohort. Patients were divided into three groups according to the method used to determine the root canal working length (WL). 35 patients in whom the WL with EAL method (EWL) was used were included in Group 1; 35 patients in whom the SWL method was used were included in Group 2; 30 patients in whom the RWL method was used were assigned to Group 3. Patient groups were randomly selected from people similar in age and gender. Age, gender, simplified oral hygiene index (OHI-S), oral and dental examinations and Visual Analogue Scale (VAS) results of all participants were recorded.

Detailed Description

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Devices that apply various methods to determine the root canal working length have been developed. The simultaneous working length determination is a newer development that allows clinicians to clean and shape root canals while monitoring the file's position inside the canal using dynamic feedback from EAL. In this method, an endodontic motor with a built-in EAL that provides continuous feedback during root canal instrumentation and allows clinicians to make real-time adjustments to the WL. Thus, it provides continuous feedback, allowing the clinician to make real-time adjustments. The motor of devices using this method has automatic apical reverse and automatic apical stop operation. In this way, when the tip of the file reaches the apical foramen, the file safely reverses and stops rotating. Thereby, SWL method reduces the risk of over- instrumentation. In this study, planned in the light of the above information, the aim of this study was to investigate the compatibility of the EWL and SWL methods in single-root teeth, in comparison with the RWL method, and to determine which one produces more effective results in terms of postoperative pain.

Conditions

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Irreversible Pulpitis Root Canal Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The randomization process of the patients participating in the study into groups was carried out by two endodontists (M.U. and S.E.) working in the unit where the research was conducted. Patients who met the inclusion criteria were randomly assigned to one of 3 groups. Additionally, patients requiring RCT for more than one tooth were randomly assigned to groups to ensure objectivity and maintain equal sample size.

Study Groups

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Electronic working length method

Electronic apex locator was used

Group Type EXPERIMENTAL

EWL

Intervention Type DEVICE

the working length determination with EAL method

Simultaneous working length method

Working length was determined by EAL and then during root canal preparation, an endodontic motor using simultaneous working length control was selected

Group Type EXPERIMENTAL

SWL

Intervention Type DEVICE

In this method, an endodontic motor with a built-in EAL that provides continuous feedback during root canal instrumentation and allows clinicians to make real-time adjustments to the WL. Thus, it provides continuous feedback, allowing the clinician to make real-time adjustments. The motor of devices using this method has automatic apical reverse and automatic apical stop operation. In this way, when the tip of the file reaches the apical foramen, the file safely reverses and stops rotating.

Radiologic working length method

30 patients in whom the radiologic working length (RWL) method. In this method, periapical radiographs were taken.

Group Type PLACEBO_COMPARATOR

RWL

Intervention Type DEVICE

Radiographic method was used for determining the working length

Interventions

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EWL

the working length determination with EAL method

Intervention Type DEVICE

SWL

In this method, an endodontic motor with a built-in EAL that provides continuous feedback during root canal instrumentation and allows clinicians to make real-time adjustments to the WL. Thus, it provides continuous feedback, allowing the clinician to make real-time adjustments. The motor of devices using this method has automatic apical reverse and automatic apical stop operation. In this way, when the tip of the file reaches the apical foramen, the file safely reverses and stops rotating.

Intervention Type DEVICE

RWL

Radiographic method was used for determining the working length

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Clinical diagnosis of irreversible pulpitis Clinical indication for root canal treatment Able to come for follow-ups

Exclusion Criteria

cardiovascular disease antibiotic or antienflammatuary drug usage during last 3 months excess coronal structure damage for rubber dam placement
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seyda Ersahan, DDS, PhD

Principal Investigator, Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine Guzel, PhD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Istanbul Medipol University, Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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491

Identifier Type: -

Identifier Source: org_study_id

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