Apical Periodontitis, Pulp Disease, Dental
Conditions
Keywords
Endodontics, Root Canal Therapy, Cone-Beam Computed Tomography, Dental Pulp Cavity, Working Length, Diagnostic Accuracy, Microscopy
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.
Detailed description
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.
Interventions
DEVICERoot ZX3 Electronic Apex Locator
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.
Sponsors
Riyadh Elm University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of the Root ZX3 electronic apex locator for working-length determination | 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
| Measure | Time frame |
|---|---|
| Repeatability of Root ZX3 measurements | before tooth extrac |
Countries
Saudi Arabia
Contacts
PRINCIPAL_INVESTIGATORAbier Fahad Alhekeir
Riyadh Elm University
Outcome results
None listed