Simultaneous Working Length Detection Methods

NCT06507982 | Completed

• 1 other identifier: 491
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Pulpitis; Root Canal Treatment

Keywords

working length; irreversible pulpitis; apex locator; radiography; simultaneous measurement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Electronic working length method

EXPERIMENTAL

Electronic apex locator was used

Device: EWL

Simultaneous working length method

EXPERIMENTAL

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

Device: SWL

Radiologic working length method

PLACEBO COMPARATOR

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

Device: RWL

Interventions

EWL DEVICE

the working length determination with EAL method

Electronic working length method

SWL 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.

Simultaneous working length method

RWL DEVICE

Radiographic method was used for determining the working length

Radiologic working length method

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Emine Guzel, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: July 18, 2024
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the acceptance of our study
• Access Criteria: Our data will be shared via email

Locations

TU (1)