In Vivo-Ex Vivo Evaluation of the Root ZX3 for Working-Length Determination
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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Riyadh Region
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Riyadh, Riyadh Region, Saudská arábie, 12755
- Abier alhekeir
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Root ZX3 Working-Length Determination
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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Diagnostic accuracy of the Root ZX3 electronic apex locator for working-length determination
Časové okno: during endodontic treatment before tooth extraction
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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.
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during endodontic treatment before tooth extraction
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Repeatability of Root ZX3 measurements
Časové okno: before tooth extrac
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before tooth extrac
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Abier Fahad Alhekeir, Riyadh Elm University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HAP-01-R-14
- 2529 (Jiný identifikátor: Saudi food and drug authority)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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Klinické studie na Root ZX3 Electronic Apex Locator
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National and Kapodistrian University of AthensAktivní, ne náborApikální parodontitida | Infekce kořenového kanálkuŘecko