Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2529 | Other Identifier | Saudi food and drug authority |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of Root ZX3 measurements | before tooth extrac |
Not provided
Inclusion Criteria:
* Adults (≥18 years) requiring extraction of a single-rooted permanent tooth for prosthodontic, periodontal, orthodontic, or non-restorable reasons.
Exclusion Criteria:
Teeth with root resorption (internal or external).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abier Fahad Alhekeir | Riyadh Elm University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abier alhekeir | Riyadh | Riyadh Region | 12755 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9487868 | Background | 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. | |
| 39102662 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D003788 | Dental Pulp Diseases |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| D014076 | Tooth Diseases |
| D017001 | Tooth Demineralization |