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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the Root ZX3 electronic apex locator for working-length determination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* 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.
排除标准
- •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 ZX
- •Teeth that fractured during extraction, preventing microscopic determination of the actual working length.
结局指标
主要结局
Diagnostic accuracy of the Root ZX3 electronic apex locator for working-length determination
时间窗: 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.
次要结局
- Repeatability of Root ZX3 measurements(before tooth extrac)
研究者
ABIER FAHAD M ALHEKEIR
Endodontic Resident, Department of Restorative Dentistry, Riyadh Elm University
Riyadh Elm University