Comparing Different Electronic Apex Locators and Periapical Radiography on Postoperative Pain

NCT07271797 | Completed

• 1 other identifier: 20210816
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study was conducted to better understand whether the method used to measure the length of root canals affects the amount of pain patients feel after root canal treatment. Accurate measurement of the root canal is important to clean and fill the tooth properly. If the canal is cleaned too short or too far, it may cause discomfort or reduce the success of the treatment.The study included 125 adult patients who had deep decay but no current pain or swelling. All had single-rooted teeth diagnosed with asymptomatic irreversible pulpitis. Participants were randomly divided into five groups, each using a different method to measure the root canal length before treatment. Four of the methods used electronic devices (called apex locators), and one used a dental X-ray. None of the patients knew which method was used in their case, and all treatments were done by the same dentist in a single appointment.Pain levels were recorded using a simple pain scale called the Visual Analog Scale (VAS), where patients marked their pain level at 6, 12, 24, and 48 hours after treatment. Patients were also allowed to take painkillers if needed, and they were asked to record how many tablets they used.The study also looked at factors like age, gender, the location of the treated tooth, and use of pain medication. The study was carried out at Bezmialem Vakif University's Department of Endodontics. All participants gave written consent, and the study was approved by the university's ethics committee. No complications or serious side effects were reported during or after the treatment.

Conditions

Postoperative Acute Pain

Keywords

electronic apex locator; working length; postoperative pain; root canal therapy

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Patient-reported pain intensity on the 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Higher scores indicate greater pain intensity. Pain levels were recorded by each participant in a diary. The analysis compares mean VAS scores among groups treated with different electronic apex locators.

  6, 12, 24, 48 hours after root canal treatment

Study Arms (5)

Group 1

EXPERIMENTAL

Identifies patients who underwent root canal treatment using Root ZX (Morita Corp., Tokyo, Japan)

Device: Root ZX (Morita Corp., Tokyo, Japan)

Group 2

EXPERIMENTAL

Identifies patients who underwent root canal treatment using Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland)

Device: Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland)

Group 3

EXPERIMENTAL

Identifies patients who underwent root canal treatment using Woodpex III (Woodpecker Medical Instrument Co., Guilin, China)

Device: Woodpex III (Woodpecker Medical Instrument Co., Guilin, China)

Group 4

EXPERIMENTAL

Identifies patients who underwent root canal treatment using Raypex 6 (VDW, Munich, Germany)

Device: Raypex 6 (VDW, Munich, Germany)

Group 5

EXPERIMENTAL

Describe patients who underwent root canal treatment using periapical radiography.

Device: periapical radiography

Interventions

Root ZX (Morita Corp., Tokyo, Japan) DEVICE

Root ZX (Morita Corp., Tokyo, Japan) is a well-established electronic apex locator widely used in endodontics for determining working length during root canal procedures. It operates based on the ratio method and has been shown to provide reliable and accurate measurements even in the presence of various irrigants. Root ZX has been extensively validated in clinical and laboratory studies and is considered a gold standard among apex locators.

Group 1

Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) DEVICE

Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) is a compact electronic apex locator designed to determine the working length of root canals with high accuracy. It uses advanced multi-frequency technology to detect the position of the apical foramen and provides real-time feedback through visual and audible signals. Despite its small size, Propex Pixi has demonstrated reliable performance in various clinical settings.

Group 2

Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) DEVICE

Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) is an electronic apex locator that operates using dual-frequency impedance technology to determine the working length of root canals. It features a user-friendly interface with visual and audible indicators, making it suitable for routine clinical use. While it is considered a cost-effective alternative to premium apex locators, studies have shown variable accuracy depending on canal conditions and the presence of irrigants.

Group 3

Raypex 6 (VDW, Munich, Germany) DEVICE

Raypex 6 (VDW, Munich, Germany) is a modern electronic apex locator that utilizes multi-frequency technology to accurately detect the apical constriction during root canal procedures. It features a color-coded graphical display and audible signals to guide clinicians throughout the procedure. Raypex 6 has been reported to provide reliable working length measurements even under challenging clinical conditions.

Group 4

periapical radiography DEVICE

Working length determination using periapical radiography involves placing a small endodontic file inside the root canal and taking a radiograph to estimate the position of the file tip relative to the root apex. This traditional technique is widely used but may be limited by image distortion, anatomical variations, and the two-dimensional nature of radiographs. Despite its limitations, it remains a common reference method in endodontic practice.

Group 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must meet all of the following criteria to be included in the trial:
• Aged between 18 and 60 years.
• Diagnosed with asymptomatic irreversible pulpitis in a single-rooted tooth and scheduled for primary root canal treatment in that tooth.
• In good general health, with no systemic diseases.
• No use of any analgesic medications within the last 24 hours prior to the treatment.
• Willing to participate in the study and able to give informed consent.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: In this single-blind clinical trial, participants were unaware of which electronic apex locator was used during root canal treatment. The operator performing the procedure knew the device allocation, but the postoperative pain data were collected by an independent investigator who was blinded to the device used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-centre endodontic trial; single visit treatment; differeant electronic apex locators.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 9, 2025
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)