Apical PeriodontitisEAL-PainNCT07527897
Effect of Integrated Apex Locator Motor Modes on Postoperative Pain in Endodontic Retreatment
A study testing Electronic Apex Locator and Integrated Apex Locator Motor in people with Apical Periodontitis and Postoperative Pain, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aimed to evaluate the effect of different integrated electronic apex locator (EAL) modes on postoperative pain following nonsurgical endodontic retreatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apical Periodontitis, Postoperative Pain, Endodontic Retreatment
- What is being tested?
- Electronic Apex Locator and Integrated Apex Locator Motor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy patients aged between 18 and 65 years
- Patients requiring nonsurgical endodontic retreatment
- Single-rooted, single-canal mandibular premolar teeth
- Diagnosis of asymptomatic apical periodontitis
- Presence of a well-defined periapical radiolucency (PAI > 4)
- Teeth with previous root canal treatment performed at least 4 years prior
- Root canal fillings extending to at least the apical third without overfilling
Who cannot join
- Patients with symptoms such as pain, swelling, or sinus tract
- Patients with a history of smoking or alcohol use
- Teeth with open apices or root resorption
- Teeth with intraradicular posts
- Teeth with insufficient coronal tooth structure
- Teeth with perforation, instrument fracture, or overfilled canals
Show all 12Show fewer
- Teeth with root curvature greater than 30 degrees
- Teeth with periodontal disease or probing depth >3 mm
- Cases not suitable for single-visit retreatment
- Patients who used analgesics within 12 hours prior to treatment
- Patients who used antibiotics within the last month
- Patients with cognitive impairment or psychological disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Faculty of Dentistry
Rize, Rize Province, 53000
About this study
Official title: Effect of Integrated Electronic Apex Locator Modes on Postoperative Pain After Root Canal Retreatment: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aimed to evaluate the effect of different integrated electronic apex locator (EAL) modes on postoperative pain following nonsurgical endodontic retreatment. A total of 144 patients requiring retreatment of mandibular premolar teeth with periapical lesions were randomly assigned to four groups.
In the control group, working length was determined using a conventional electronic apex locator. In the experimental groups, an integrated EAL motor was used with three different modes: apical reverse, apical slow down, and apical stop.
Read more
All procedures were performed under standardized conditions. Postoperative pain was assessed using a numeric rating scale (NRS) at 6 and 12 hours and on days 1, 2, 3, 5, and 7 after treatment.
The study aimed to determine whether simultaneous working length control using integrated EAL modes influences postoperative pain compared with conventional working length determination.
Read the detailed description
Accurate determination and maintenance of working length is essential for successful endodontic retreatment. Electronic apex locators (EALs) are widely used to improve the accuracy of working length determination. Recently, endodontic motors with integrated EAL systems have been developed, enabling simultaneous working length control during canal instrumentation. These systems incorporate different automatic apical control modes, including apical reverse, apical slow down, and apical stop, which may influence clinical outcomes such as postoperative pain.
This randomized controlled clinical trial was conducted to evaluate the effects of different integrated EAL modes on postoperative pain following nonsurgical endodontic retreatment.
A total of 144 systemically healthy patients with previously treated single-rooted mandibular premolars diagnosed with asymptomatic apical periodontitis were included. Patients were randomly allocated into four groups (n=36 each): (1) conventional electronic apex locator (control group; Root ZX Mini), (2) integrated EAL motor with apical reverse mode, (3) apical slow down mode, and (4) apical stop mode (Ai Motor; Motopex; Woodpecker).
In the control group, working length was determined using a conventional EAL and confirmed radiographically. In the experimental groups, working length determination and instrumentation were performed simultaneously using an integrated EAL motor according to the assigned apical mode.
All retreatment procedures were completed in a single visit under standardized clinical conditions by a single experienced operator. Root canal filling materials were removed, canals were prepared using rotary instruments, and irrigation was performed using 2.5% sodium hypochlorite and 17% EDTA with ultrasonic activation. Final obturation was carried out using a single-cone technique with a bioceramic sealer.
Postoperative pain was assessed using an 11-point numeric rating scale (NRS) at 6 and 12 hours and on days 1, 2, 3, 5, and 7 after treatment. The primary outcome measure was postoperative pain intensity.
The study evaluated whether different simultaneous working length control strategies using integrated EAL modes affect postoperative pain compared with the conventional electronic apex locator method.
- Being tested
- Electronic Apex Locator, Integrated Apex Locator Motor
- Keywords
- Electronic apex locators, Time factors, Endodontics, Retreatment, Postoperative pain
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Apex LocatorDevice
Also called Root ZX Mini
Working length was determined using a conventional electronic apex locator (Root ZX Mini). The measurement was confirmed radiographically, and endodontic retreatment procedures were completed under standardized clinical conditions.
Integrated Apex Locator MotorDevice
Also called Apical Reverse Mode, Apical Slow Down Mode, Apical Stop Mode
Working length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor (Ai Motor, Motopex, Woodpecker). The device operates with different apical control modes, including apical reverse, apical slow down, and apical stop, which automatically respond when the file reaches the predefined working length.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Electronic Apex Locator | Active comparator | Working length was determined using a conventional electronic apex locator (Root ZX Mini) and confirmed radiographically. Endodontic retreatment procedures were completed using standardized protocols. Receives: Device: Electronic Apex Locator |
| Apical Reverse Mode | Experimental | Working length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical reverse mode during endodontic retreatment. Receives: Device: Integrated Apex Locator Motor |
| Apical Slow Down Mode | Experimental | Working length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical slow down mode during endodontic retreatment. Receives: Device: Integrated Apex Locator Motor |
| Apical Stop Mode | Experimental | Working length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical stop mode during endodontic retreatment. Receives: Device: Integrated Apex Locator Motor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Postoperative pain intensity was assessed using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores were recorded at 6 and 12 hours and on days 1, 2, 3, 5, and 7 following endodontic retreatment.
Measured: 6 hours, 12 hours, and days 1, 2, 3, 5, and 7 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start13 Aug 2025
- Primary completion10 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to four parallel groups to compare conventional electronic apex locator use with three different integrated apex locator motor modes (apical reverse, apical slow down, and apical stop) during endodontic retreatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HASAN UYANIK, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527897
- Sponsor's protocol ID
- EAL-RCT-2025
- Other IDs
- 2025/113, E-24931227-514.13.02-5708670
- Acronym
- EAL-Pain
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrated Electronic Apex Locator Modes on Postoperative Pain After Root Canal Retreatment: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07527897
- Acronym / sponsor ID
- EAL-Pain / EAL-RCT-2025
- Keywords
- Electronic apex locators, Time factors, Endodontics, Retreatment, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial aimed to evaluate the effect of different integrated electronic apex locator (EAL) modes on postoperative pain following nonsurgical endodontic retreatment. A total of 144 patients requiring retreatment of mandibular premolar teeth with periapical lesions were randomly assigned to four groups.
In the control group, working length was determined using a conventional electronic apex locator. In the experimental groups, an integrated EAL motor was used with three different modes: apical reverse, apical slow down, and apical stop.
All procedures were performed under standardized conditions. Postoperative pain was assessed using a numeric rating scale (NRS) at 6 and 12 hours and on days 1, 2, 3, 5, and 7 after treatment.
The study aimed to determine whether simultaneous working length control using integrated EAL modes influences postoperative pain compared with conventional working length determination.
Detailed description
Accurate determination and maintenance of working length is essential for successful endodontic retreatment. Electronic apex locators (EALs) are widely used to improve the accuracy of working length determination. Recently, endodontic motors with integrated EAL systems have been developed, enabling simultaneous working length control during canal instrumentation. These systems incorporate different automatic apical control modes, including apical reverse, apical slow down, and apical stop, which may influence clinical outcomes such as postoperative pain.
This randomized controlled clinical trial was conducted to evaluate the effects of different integrated EAL modes on postoperative pain following nonsurgical endodontic retreatment.
A total of 144 systemically healthy patients with previously treated single-rooted mandibular premolars diagnosed with asymptomatic apical periodontitis were included. Patients were randomly allocated into four groups (n=36 each): (1) conventional electronic apex locator (control group; Root ZX Mini), (2) integrated EAL motor with apical reverse mode, (3) apical slow down mode, and (4) apical stop mode (Ai Motor; Motopex; Woodpecker).
In the control group, working length was determined using a conventional EAL and confirmed radiographically. In the experimental groups, working length determination and instrumentation were performed simultaneously using an integrated EAL motor according to the assigned apical mode.
All retreatment procedures were completed in a single visit under standardized clinical conditions by a single experienced operator. Root canal filling materials were removed, canals were prepared using rotary instruments, and irrigation was performed using 2.5% sodium hypochlorite and 17% EDTA with ultrasonic activation. Final obturation was carried out using a single-cone technique with a bioceramic sealer.
Postoperative pain was assessed using an 11-point numeric rating scale (NRS) at 6 and 12 hours and on days 1, 2, 3, 5, and 7 after treatment. The primary outcome measure was postoperative pain intensity.
The study evaluated whether different simultaneous working length control strategies using integrated EAL modes affect postoperative pain compared with the conventional electronic apex locator method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants were randomly assigned to four parallel groups to compare conventional electronic apex locator use with three different integrated apex locator motor modes (apical reverse, apical slow down, and apical stop) during endodontic retreatment.
| Arm | Type | Receives |
|---|---|---|
| Conventional Electronic Apex Locator | Active comparator | Device: Electronic Apex LocatorWorking length was determined using a conventional electronic apex locator (Root ZX Mini) and confirmed radiographically. Endodontic retreatment procedures were completed using standardized protocols. |
| Apical Reverse Mode | Experimental | Device: Integrated Apex Locator MotorWorking length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical reverse mode during endodontic retreatment. |
| Apical Slow Down Mode | Experimental | Device: Integrated Apex Locator MotorWorking length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical slow down mode during endodontic retreatment. |
| Apical Stop Mode | Experimental | Device: Integrated Apex Locator MotorWorking length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical stop mode during endodontic retreatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Systemically healthy patients aged between 18 and 65 years
- Patients requiring nonsurgical endodontic retreatment
- Single-rooted, single-canal mandibular premolar teeth
- Diagnosis of asymptomatic apical periodontitis
- Presence of a well-defined periapical radiolucency (PAI > 4)
Key exclusion criteria (12 listed)
- Patients with symptoms such as pain, swelling, or sinus tract
- Patients with a history of smoking or alcohol use
- Teeth with open apices or root resorption
- Teeth with intraradicular posts
- Teeth with insufficient coronal tooth structure
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 |
|---|---|---|
| Electronic Apex LocatorAlso: Root ZX MiniWorking length was determined using a conventional electronic apex locator (Root ZX Mini). The measurement was confirmed radiographically, and endodontic retreatment procedures were completed under standardized clinical conditions. | Device | Conventional Electronic Apex Locator |
| Integrated Apex Locator MotorAlso: Apical Reverse Mode, Apical Slow Down Mode, Apical Stop ModeWorking length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor (Ai Motor, Motopex, Woodpecker). The device operates with different apical control modes, including apical reverse, apical slow down, and apical stop, which automatically respond when the file reaches the predefined working length. | Device | Apical Reverse Mode, Apical Slow Down Mode, Apical Stop Mode |
Primary outcome
Primary Outcome Measure
Time frame: 6 hours, 12 hours, and days 1, 2, 3, 5, and 7 after treatment
Postoperative pain intensity was assessed using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores were recorded at 6 and 12 hours and on days 1, 2, 3, 5, and 7 following endodontic retreatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Apex Locator and Integrated Apex Locator Motor in people with Apical Periodontitis and Postoperative Pain, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 7 inclusion and 12 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 14 Apr 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Outcome Measure (time frame: 6 hours, 12 hours, and days 1, 2, 3, 5, and 7 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.