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Completed

NCT Number: NCT07689838

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abier alhekeir

Riyadh, Riyadh Region, 12755, Saudi Arabia

About this study

Accurate determination of root canal working length is essential for successful endodontic treatment because instrumentation and obturation should terminate at an appropriate apical endpoint. Electronic apex locators have become widely used to improve working-length determination and reduce reliance on radiographic methods. The Root ZX3 is a third-generation electronic apex locator that has demonstrated promising accuracy; however, limited evidence exists regarding its performance under different pulpal and periapical conditions using microscopic actual working length as the reference standard.

This prospective mixed in vivo-ex vivo diagnostic accuracy study evaluates the accuracy and repeatability of the Root ZX3 electronic apex locator in single-rooted permanent teeth indicated for extraction. Adult participants requiring extraction of teeth for prosthodontic, periodontal, orthodontic, or non-restorable reasons and requiring primary nonsurgical root canal treatment are enrolled after providing informed consent.

Before tooth extraction, electronic working length is determined using the Root ZX3 according to the manufacturer's instructions with a standardized coronal reference point. Pulpal and periapical diagnoses are recorded clinically. After extraction, limited field-of-view CBCT imaging is performed, and working length is measured using standardized imaging protocols. The actual working length is then determined microscopically by directly identifying the apical foramen and is used as the reference standard.

The primary outcome is the diagnostic accuracy of the Root ZX3 compared with the microscopic actual working length. Accuracy is evaluated as the proportion of measurements within ±0.5 mm and ±1.0 mm of the reference standard. Agreement between measurement methods is assessed using Bland-Altman analysis, Lin's concordance correlation coefficient, and the intraclass correlation coefficient. Repeatability of electronic measurements is also evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • * 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: during endodontic treatment before tooth extraction

    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.

Secondary outcomes

  1. Repeatability of Root ZX3 measurements

    Time frame: before tooth extrac

Sponsors and collaborators

Lead sponsor

Riyadh Elm University

Other

Registry information

Official study title

Accuracy and Precision of the Root ZX3 Electronic Apex Locator for Working-Length Determination in Teeth With Different Pulpal and Periapical Conditions: A Mixed In Vivo-Ex Vivo Diagnostic Accuracy Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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