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CompletedNCT06507982Updated Jul 18, 2024

Simultaneous Working Length Detection Methods

An interventional study of EWL and SWL in Irreversible Pulpitis and Root Canal Treatment, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jun 2022, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Irreversible Pulpitis
  • Root Canal Treatment

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Keywords

  • working length
  • irreversible pulpitis
  • apex locator
  • radiography
  • simultaneous measurement
03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 100 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Electronic working length method

    Electronic apex locator was used

    Device: EWL

  • 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

  • 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

Interventions

  • DeviceEWL

    the working length determination with EAL method

  • DeviceSWL

    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.

  • DeviceRWL

    Radiographic method was used for determining the working length

06

What researchers measure

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

    Time frame: Baseline, 24 hour postoperatively, 48hour postoperatively, 72 hour postoperatively, Day 3 and Day 7

07

Study locations

1 site
  • Istanbul Medipol University, Faculty of Dentistry
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: Yes — Upon request from the authors with a reasonable request, our data will be made open

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06507982
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
Seyda Ersahan, DDS, PhD (Principal Investigator, Clinical Associate Professor, Istanbul Medipol University Hospital) — Principal investigator
First posted
Jul 18, 2024
Start date
Jun 1, 2022
Primary completion
Jan 1, 2024
Completion
Mar 1, 2024
Last update
Jul 18, 2024

Study contacts

Emine Guzel, PhD
principal investigator · Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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