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

1. juli 2026 opdateret af: ABIER FAHAD M ALHEKEIR, Riyadh Elm University

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Saudi Arabien
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabien, 12755
        • Abier alhekeir

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Root 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic accuracy of the Root ZX3 electronic apex locator for working-length determination
Tidsramme: 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.
during endodontic treatment before tooth extraction

Sekundære resultatmål

Resultatmål
Tidsramme
Repeatability of Root ZX3 measurements
Tidsramme: before tooth extrac
before tooth extrac

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Riyadh Elm University

Efterforskere

  • Ledende efterforsker: Abier Fahad Alhekeir, Riyadh Elm University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. oktober 2025

Primær færdiggørelse (Faktiske)

28. februar 2026

Studieafslutning (Faktiske)

30. juni 2026

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HAP-01-R-14
  • 2529 (Anden identifikator: Saudi food and drug authority)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Apikal parodontitis

Kliniske forsøg med Root ZX3 Electronic Apex Locator

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