In Vivo-Ex Vivo Evaluation of the Root ZX3 for Working-Length Determination

NCT07689838 | Completed DMC

• 2 other identifiers: HAP-01-R-142529
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the accuracy and repeatability of the Root ZX3 electronic apex locator for determining root canal working length in single-rooted permanent teeth requiring extraction. Before extraction, working length is measured clinically using the Root ZX3. Following extraction, cone-beam computed tomography (CBCT) measurements and microscopic actual working length are obtained, with the microscopic measurement serving as the reference standard. The study compares the diagnostic accuracy and agreement of the Root ZX3 with these reference measurements across different pulpal and periapical conditions.

Conditions

Apical Periodontitis; Pulp Disease, Dental

Keywords

Endodontics; Root Canal Therapy; Cone-Beam Computed Tomography; Dental Pulp Cavity; Working Length; Diagnostic Accuracy; Microscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the Root ZX3 electronic apex locator for working-length determination

  The diagnostic accuracy of the Root ZX3 electronic apex locator was evaluated by comparing electronic working-length measurements with the microscopic actual working length, which served as the reference standard. Accuracy was assessed by the proportion of measurements within ±0.5 mm and ±1.0 mm of the reference standard. Agreement was further evaluated using mean differences and Bland-Altman analysis.

  during endodontic treatment before tooth extraction

Secondary Outcomes (1)

• Repeatability of Root ZX3 measurements

  before tooth extrac

Study Arms (1)

Root ZX3 Working-Length Determination

EXPERIMENTAL

Participants underwent electronic working-length determination using the Root ZX3 electronic apex locator during primary nonsurgical root canal treatment. Electronic working-length measurements were obtained before tooth extraction and subsequently compared with cone-beam computed tomography (CBCT) measurements and microscopic actual working length, with the microscopic measurement serving as the reference standard for evaluating diagnostic accuracy and precision.

Device: Root ZX3 Electronic Apex Locator

Interventions

Root ZX3 Electronic Apex Locator DEVICE

The Root ZX3 electronic apex locator was used to determine electronic working length in single-rooted permanent teeth during primary nonsurgical root canal treatment according to the manufacturer's instructions. A size 10 or 15 K-file was advanced within the root canal until the device indicated the apical foramen (red bar), and the working length was recorded using a standardized coronal reference point. Electronic measurements were compared with microscopic actual working length after tooth extraction, which served as the reference standard. Cone-beam computed tomography (CBCT) measurements were also obtained for comparison.

Root ZX3 Working-Length Determination

Eligibility Criteria

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

You may qualify if:

• \* Adults (≥18 years) requiring extraction of a single-rooted permanent tooth for prosthodontic, periodontal, orthodontic, or non-restorable reasons.
• Tooth requiring primary nonsurgical root canal treatment.
• Fully formed root with a closed apex.
• Ability to provide written informed consent.

You may not qualify if:

• Teeth with root resorption (internal or external).
• Teeth with root perforation or previous endodontic treatment.
• Teeth with immature (open) apices.
• Teeth with root fractures.
• Teeth in which apical patency could not be achieved.
• Teeth with no electronic working-length measurement obtained using the Root ZX3.
• Teeth that fractured during extraction, preventing microscopic determination of the actual working length.

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Abier alhekeir

Riyadh, Riyadh Region, 12755, Saudi Arabia

Location

Related Publications (2)

• Dunlap CA, Remeikis NA, BeGole EA, Rauschenberger CR. An in vivo evaluation of an electronic apex locator that uses the ratio method in vital and necrotic canals. J Endod. 1998 Jan;24(1):48-50. doi: 10.1016/S0099-2399(98)80214-8.

  PMID: 9487868 BACKGROUND

• Izadi A, Golmakani F, Kazeminejad E, Mahdavi Asl A. Accuracy of Working Length Measurement Using Cone Beam Computed Tomography at Three Field of View Settings, Conventional Radiography, and Electronic Apex Locator: An Ex-vivo Study. Eur Endod J. 2024 Aug 22;9(3):266-272. doi: 10.14744/eej.2023.97769.

  PMID: 39102662 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Diseases; Dental Caries

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Tooth Diseases; Tooth Demineralization

Study Officials

• Abier Fahad Alhekeir

  Riyadh Elm University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endodontic Resident, Department of Restorative Dentistry, Riyadh Elm University

Model Details: All participants underwent the same study procedures. Electronic working length was determined using the Root ZX3 before tooth extraction. Measurements were subsequently compared with cone-beam computed tomography (CBCT) measurements and microscopic actual working length obtained after extraction, which served as the reference standard.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: October 19, 2025
• Primary Completion: February 28, 2026
• Study Completion: June 30, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)