Apical PeriodontitisNCT07689838
In-Vivo Diagnostic Accuracy and Repeatability of Root ZX3 for Working-Length Determination in Single-Rooted Teeth: Agreement With CBCT and Microscopic Validation
A study testing Root ZX3 Electronic Apex Locator in people with Apical Periodontitis and Pulp Disease, Dental, run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial summary
This study evaluated the accuracy and repeatability of the Root ZX3 electronic apex locator for working-length determination in 77 single-rooted permanent teeth. Root ZX3 measurements obtained before extraction were compared with CBCT measurements and direct microscopic measurements of the apical foramen after… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Pulp Disease, Dental, Device Reliability
- What is being tested?
- Root ZX3 Electronic Apex Locator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 19 Oct 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -Patient-related: Implantable electronic devices Relevant medical history Contraindications or anticipated complications related to extraction Known allergies to study materials
- -Tooth-related: Previous endodontic treatment Trauma Hypercementosis Root resorption Canal curvature ≥20° Extensive restorations Canal obliteration Failed rubber dam isolation
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluated the accuracy and repeatability of the Root ZX3 electronic apex locator for working-length determination in 77 single-rooted permanent teeth. Root ZX3 measurements obtained before extraction were compared with CBCT measurements and direct microscopic measurements of the apical foramen after extraction.
Read the detailed description
This prospective in vivo-ex vivo study assessed Root ZX3 working-length determination in single-rooted permanent teeth. Seventy-seven teeth from adults undergoing clinically indicated extraction were included.
Root ZX3 measurements were obtained before extraction by a calibrated endodontist. After extraction, the teeth were evaluated using CBCT and direct microscopic visualization of the apical foramen. The microscopic measurement served as the reference standard. CBCT measurements were performed independently by two calibrated endodontists, with the secondary examiner assessing a subset of 20 teeth.
Root ZX3 accuracy was assessed by comparing its measurements with the microscopic reference standard, including the proportions within ±0.5 mm and ±1.0 mm. Repeatability of Root ZX3 measurements, agreement between Root ZX3 and CBCT, CBCT interobserver agreement, and differences according to clinical status were also evaluated.
Statistical analyses included McNemar's test, Bland-Altman analysis, Lin's concordance correlation coefficient, intraclass correlation coefficients, and a linear mixed-effects sensitivity analysis.
- Being tested
- Root ZX3 Electronic Apex Locator
- Keywords
- Endodontics, Root Canal Therapy, Cone-Beam Computed Tomography, Dental Pulp Cavity, Working Length, Diagnostic Accuracy, Microscopy
- Medical subject headings
- Periapical Periodontitis, Dental Pulp Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root ZX3 Electronic Apex LocatorDevice
The Root ZX3 electronic apex locator was used for in vivo working-length determination during primary nonsurgical root canal treatment. Following access preparation, preflaring, and irrigation, a size 10 or 15 K-file was advanced through the canal until the device indicated the apical foramen. A stable reading for at least 5 seconds was required, and the file position was measured from a standardized coronal reference point. The measurement was repeated under identical conditions to evaluate intraoperator repeatability. After extraction, the Root ZX3 measurements were compared with the actual working length determined by direct microscopic visualization of the apical foramen. CBCT working-length measurements were also obtained independently for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Root ZX3 Working-Length Determination | Experimental | Participants underwent clinical pulpal and apical diagnosis followed by in vivo working-length determination using the Root ZX3 in single-rooted permanent teeth before clinically indicated extraction. After extraction, the same teeth underwent CBCT assessment and direct microscopic determination of the apical foramen. Root ZX3 measurements were compared with the microscopic working length as the reference standard, while CBCT measurements were evaluated for comparison. Root ZX3 measurement error was also assessed according to combined pulpal and apical diagnostic status. Receives: Device: Root ZX3 Electronic Apex Locator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 microscopic actual working length, which served as the reference standard. Accuracy was assessed as the proportion of measurements within ±0.5 mm and ±1.0 mm of the reference standard. Agreement was also evaluated using mean differences and Bland-Altman analysis.
Measured: during endodontic treatment before tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start19 Oct 2025
- Primary completion28 Feb 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants underwent the same study procedures. Root ZX3 working length was measured before tooth extraction and compared with CBCT measurements and microscopic actual working length obtained after extraction. Microscopic measurement served as the reference standard.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ABIER FAHAD M ALHEKEIR, Riyadh Elm University
- Investigators
- Abier Fahad Alhekeir, Principal investigator, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689838
- Sponsor's protocol ID
- HAP-01-R-14
- Other IDs
- 2529, FPGRP/2025/930/1310/1207
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared publicly. The study dataset and protocol are available from the corresponding author upon reasonable request, subject to appropriate institutional and ethical considerations.
Publications
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.
PubMed 9487868Izadi 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.
PubMed 39102662
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Diagnostic Accuracy and Repeatability of Root ZX3 for Working-Length Determination in Single-Rooted Teeth: Agreement With CBCT and Microscopic Validation
- ClinicalTrials.gov ID
- NCT07689838
- Acronym / sponsor ID
- HAP-01-R-14
- Keywords
- Endodontics, Root Canal Therapy, Cone-Beam Computed Tomography, Dental Pulp Cavity, Working Length, Diagnostic Accuracy, Microscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 19 Oct 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the accuracy and repeatability of the Root ZX3 electronic apex locator for working-length determination in 77 single-rooted permanent teeth. Root ZX3 measurements obtained before extraction were compared with CBCT measurements and direct microscopic measurements of the apical foramen after extraction.
Detailed description
This prospective in vivo-ex vivo study assessed Root ZX3 working-length determination in single-rooted permanent teeth. Seventy-seven teeth from adults undergoing clinically indicated extraction were included.
Root ZX3 measurements were obtained before extraction by a calibrated endodontist. After extraction, the teeth were evaluated using CBCT and direct microscopic visualization of the apical foramen. The microscopic measurement served as the reference standard. CBCT measurements were performed independently by two calibrated endodontists, with the secondary examiner assessing a subset of 20 teeth.
Root ZX3 accuracy was assessed by comparing its measurements with the microscopic reference standard, including the proportions within ±0.5 mm and ±1.0 mm. Repeatability of Root ZX3 measurements, agreement between Root ZX3 and CBCT, CBCT interobserver agreement, and differences according to clinical status were also evaluated.
Statistical analyses included McNemar's test, Bland-Altman analysis, Lin's concordance correlation coefficient, intraclass correlation coefficients, and a linear mixed-effects sensitivity analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants underwent the same study procedures. Root ZX3 working length was measured before tooth extraction and compared with CBCT measurements and microscopic actual working length obtained after extraction. Microscopic measurement served as the reference standard.
| Arm | Type | Receives |
|---|---|---|
| Root ZX3 Working-Length Determination | Experimental | Device: Root ZX3 Electronic Apex LocatorParticipants underwent clinical pulpal and apical diagnosis followed by in vivo working-length determination using the Root ZX3 in single-rooted permanent teeth before clinically indicated extraction. After extraction, the same teeth underwent CBCT assessment and direct microscopic determination of the apical foramen. Root ZX3 measurements were compared with the microscopic working length as the reference standard, while CBCT measurements were evaluated for comparison. Root ZX3 measurement error was also assessed according to combined pulpal and apical diagnostic status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- -Patient-related: Implantable electronic devices Relevant medical history Contraindications or anticipated complications related to extraction Known allergies to study materials
- -Tooth-related: Previous endodontic treatment Trauma Hypercementosis Root resorption Canal curvature ≥20° Extensive restorations Canal obliteration Failed rubber dam isolation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root ZX3 Electronic Apex LocatorThe Root ZX3 electronic apex locator was used for in vivo working-length determination during primary nonsurgical root canal treatment. Following access preparation, preflaring, and irrigation, a size 10 or 15 K-file was advanced through the canal until the device indicated the apical foramen. A stable reading for at least 5 seconds was required, and the file position was measured from a standardized coronal reference point. The measurement was repeated under identical conditions to evaluate intraoperator repeatability. After extraction, the Root ZX3 measurements were compared with the actual working length determined by direct microscopic visualization of the apical foramen. CBCT working-length measurements were also obtained independently for comparison. | Device | Root ZX3 Working-Length Determination |
Primary outcome
Diagnostic Accuracy of the Root ZX3 Electronic Apex Locator for Working-length Determination
Time frame: 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 microscopic actual working length, which served as the reference standard. Accuracy was assessed as the proportion of measurements within ±0.5 mm and ±1.0 mm of the reference standard. Agreement was also evaluated using mean differences and Bland-Altman analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9487868Dunlap 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.
- Background: PubMed 39102662Izadi 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. The study dataset and protocol are available from the corresponding author upon reasonable request, subject to appropriate institutional and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abier Fahad Alhekeir principal investigator
Riyadh Elm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root ZX3 Electronic Apex Locator in people with Apical Periodontitis and Pulp Disease, Dental, run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the Root ZX3 Electronic Apex Locator for Working-length Determination (time frame: during endodontic treatment before tooth extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689838, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.