Simultaneous Working Length Detection Methods

Comparison of Electronic Apex Locator and Simultaneous Working Length Detection Methods With Radiological Method in Terms of Postoperative Pain

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.

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis; Root Canal Treatment
• Intervention / Treatment: Device: EWL; Device: SWL; Device: RWL

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Medipol University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic working length method; Electronic apex locator was used	Device: EWL; the working length determination with EAL method
Experimental: 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	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.
Placebo Comparator: Radiologic working length method; 30 patients in whom the radiologic working length (RWL) method. In this method, periapical radiographs were taken.	Device: RWL; Radiographic method was used for determining the working length

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain evaluation by VAS scale	during first week after root canal treatment, postoperative pain was evaluated. From start of endodontic treatment up to 1 week, pain was evaluated using VAS scale VAS scale was used, which has 1 to 10 number Number 10 in VAS indicates severe pain, while 0 indicates no pain	Baseline, 24 hour postoperatively, 48hour postoperatively, 72 hour postoperatively, Day 3 and Day 7

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Emine Guzel, PhD, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: radiography; irreversible pulpitis; working length; apex locator; simultaneous measurement
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: 491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request from the authors with a reasonable request, our data will be made open
• IPD Sharing Time Frame: After the acceptance of our study
• IPD Sharing Access Criteria: Our data will be shared via email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No