RetreatmentPhase 4NCT06964490
Effect of Different Apex Locators on Postoperative Pain in Endodontic Retreatment of Single-Rooted Teeth: Prospective Randomized Clinical Study
A Phase 4 study testing determination of working length in people with Retreatment, run by Ipek Eraslan Akyuz.
Trial summary
Nonsurgical endodontic retreatment is a vital procedure that promotes periapical healing by eliminating previous root canal fillings, necrotic tissue, and residual microorganisms, thanks to the comprehensive cleaning of the root canal system [1]. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Retreatment
- What is being tested?
- determination of working length
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. ASA I or II individuals aged 18-60 years 2. Single-rooted, single-canaled teeth treated with root canal therapy ≥4 years ago 3. Root canal fillings ending 2-3 mm short of the radiographic apex 4. Diagnosis of asymptomatic apical periodontitis 5. Periapical Index (PAI) score of 2-4 [17], with no periodontal or prosthetic treatment needs 6. Root canal curvature <30° 7. Radiographically confirmed complete root formation and absence of resorption 8. Ability to achieve rubber dam isolation during treatment 9. Voluntary participation with signed informed consent
Who cannot join
- 1. Use of analgesics, antibiotics, or corticosteroids within the past two weeks 2. Periodontal attachment loss (probing depth > 4 mm) 3. Teeth with vertical root fractures, external resorption, or perforations 4. Teeth with fractured instruments inside the root canal system 5. Severe root curvature or excessive coronal destruction on preoperative radiographs 6. Canal calcification, root resorption, or incomplete root development 7. Cognitive impairment, mental retardation, or inability to comply due to old age 8. Pregnancy or lactation 9. Presence of systemic conditions (e.g., widespread infection, cancer, cardiovascular disease, advanced diabetes)
About this study
Nonsurgical endodontic retreatment is a vital procedure that promotes periapical healing by eliminating previous root canal fillings, necrotic tissue, and residual microorganisms, thanks to the comprehensive cleaning of the root canal system [1]. The successful disinfection of intricate anatomical structures, such as dentinal tubules, lateral canals, and isthmuses, largely depends on the effective removal of obturation materials [2]. Even in the absence of coronal leakage or recurrent caries, persistent clinical symptoms or radiographic evidence of periapical pathology may indicate treatment failure, warranting retreatment [3]. Residual bacteria and remnants of root filling materials are known contributors to posttreatment disease [4].
A key factor in the success of both primary endodontic treatment and retreatment is the accurate determination of working length (WL), which dictates the apical extent of canal instrumentation and obturation [5]. Inadequate WL may result in over-instrumentation, leading to periapical irritation and postoperative pain [6]. WL is generally defined as the distance from a coronal reference point to the location where canal cleaning, shaping, and filling should ideally terminate, often coinciding with the apical constriction, and occasionally with the cementodentinal junction, where pulpal and periodontal tissues transition [5].
Read more
Although periapical radiographs are still commonly used for WL determination, they do not always provide definitive results due to certain limitations. Factors such as improper film placement, angular distortion, image magnification and distortion, patient exposure to ionizing radiation, and the superimposition of anatomical structures can compromise the accuracy of measurements [7]. As a result, electronic apex locators (EALs) have gained prominence as a dependable and objective tool for determining WL, offering real-time measurements less influenced by operator variability or anatomical distortions [6].
The initial generations of electronic apex locators (EALs) exhibited inconsistent readings and limited accuracy, particularly in the presence of irrigation solutions or tissue fluids. However, recent advancements have significantly enhanced the reliability and clinical performance of EALs. Modern EALs, such as the ProPex Pixi (Dentsply, Switzerland) and Root ZX (J. Morita, Japan) apex locators, utilize multiple-frequency impedance measurements to detect changes as the file approaches the minor apical foramen [8]. These devices are equipped with microprocessors that analyze real-time impedance variations, allowing for dynamic and accurate assessment of canal length during instrumentation. Thanks to these technological enhancements, contemporary EALs can precisely identify the apical constriction, even under challenging clinical conditions [9]. Recent studies have demonstrated that modern devices can achieve up to 90% accuracy in WL determination, making them indispensable tools in both primary and secondary endodontic procedures [9, 10]. Raypex (Raypex 6, VDW GmbH, Munich, Germany) is another widely used electronic apex locator (EAL). Aydın et al. [11] demonstrated that Raypex 6 showed success rates of 85% and 95% within ±0.5 mm and ±1 mm, respectively, in teeth with mature apices. Although apex locators function with the same principle, the areas detected by different devices may differ. These variations in apical measurements among different EALs may not only affect treatment accuracy but could also influence the extent of postoperative pain experienced by the patient.
Postoperative pain is a significant concern in endodontics, with its incidence ranging from 3% to 58% [12]. Irritation of periradicular tissues during root canal treatment induces an acute inflammatory response, leading to the release of chemical mediators and changes in local pressure and tissue adaptation [13]. Accurate WL determination plays a critical role in minimizing postoperative pain [14]. Although the use of electronic EALs in WL determination during root canal treatment has been widely accepted, there are only a limited number of clinical studies investigating their effect on postoperative pain. Recent studies have explored the clinical performance and accuracy of different EALs; however, their focus was primarily on measurement precision rather than postoperative outcomes like pain or patient comfort [7, 15].
Despite the increasing use of EALs in endodontic procedures, there is currently no clinical study that examines the impact of using different apex locator devices on postoperative pain in the nonsurgical endodontic retreatment. Given the added complexity of retreatment cases, such as the need to remove previous obturation materials and the potential for greater periapical irritation, this represents a significant gap in the literature. The primary aim of this randomized clinical study is to evaluate and compare the effect of WL determination using different apex locator
- Conditions
- Retreatment
- Being tested
- determination of working length
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determination of working lengthDevice
Compare the effect of WL determination using different apex locator devices (ProPex Pixi, Root ZX, and Raypex 6) on the incidence and intensity of postoperative pain following endodontic retreatment in single-rooted teeth
| Study group | Role | What they receive |
|---|---|---|
| ProPex Pixi Apex Locator | Experimental | Not described Receives: Device: determination of working length |
| Root ZX Apex Locator | Experimental | Not described Receives: Device: determination of working length |
| Raypex 6 Apex Locator | Experimental | Not described Receives: Device: determination of working length |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by Visual Analog Scale (VAS)
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 100-mm line where patients mark their pain level. VAS scores will be categorized as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Patients will record their pain at 6, 12, and 24 hours postoperatively, and daily for up to 7 days following endodontic retreatment. Pain scores will be compared among the three apex locator groups (ProPex Pixi, Root ZX, Raypex 6) to assess the impact of different devices on postoperative pain levels.
Measured: From 6 hours up to 7 days after endodontic retreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetreatmentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipek Eraslan Akyuz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ipek Eraslan Akyuz, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964490
- Sponsor's protocol ID
- 2025/3
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Apex Locators on Postoperative Pain in Endodontic Retreatment of Single-Rooted Teeth: Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06964490
- Acronym / sponsor ID
- 2025/3
- Conditions
- Retreatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ipek Eraslan AkyuzUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 9 May 2025 (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.
Nonsurgical endodontic retreatment is a vital procedure that promotes periapical healing by eliminating previous root canal fillings, necrotic tissue, and residual microorganisms, thanks to the comprehensive cleaning of the root canal system [1]. The successful disinfection of intricate anatomical structures, such as dentinal tubules, lateral canals, and isthmuses, largely depends on the effective removal of obturation materials [2]. Even in the absence of coronal leakage or recurrent caries, persistent clinical symptoms or radiographic evidence of periapical pathology may indicate treatment failure, warranting retreatment [3]. Residual bacteria and remnants of root filling materials are known contributors to posttreatment disease [4].
A key factor in the success of both primary endodontic treatment and retreatment is the accurate determination of working length (WL), which dictates the apical extent of canal instrumentation and obturation [5]. Inadequate WL may result in over-instrumentation, leading to periapical irritation and postoperative pain [6]. WL is generally defined as the distance from a coronal reference point to the location where canal cleaning, shaping, and filling should ideally terminate, often coinciding with the apical constriction, and occasionally with the cementodentinal junction, where pulpal and periodontal tissues transition [5].
Although periapical radiographs are still commonly used for WL determination, they do not always provide definitive results due to certain limitations. Factors such as improper film placement, angular distortion, image magnification and distortion, patient exposure to ionizing radiation, and the superimposition of anatomical structures can compromise the accuracy of measurements [7]. As a result, electronic apex locators (EALs) have gained prominence as a dependable and objective tool for determining WL, offering real-time measurements less influenced by operator variability or anatomical distortions [6].
The initial generations of electronic apex locators (EALs) exhibited inconsistent readings and limited accuracy, particularly in the presence of irrigation solutions or tissue fluids. However, recent advancements have significantly enhanced the reliability and clinical performance of EALs. Modern EALs, such as the ProPex Pixi (Dentsply, Switzerland) and Root ZX (J. Morita, Japan) apex locators, utilize multiple-frequency impedance measurements to detect changes as the file approaches the minor apical foramen [8]. These devices are equipped with microprocessors that analyze real-time impedance variations, allowing for dynamic and accurate assessment of canal length during instrumentation. Thanks to these technological enhancements, contemporary EALs can precisely identify the apical constriction, even under challenging clinical conditions [9]. Recent studies have demonstrated that modern devices can achieve up to 90% accuracy in WL determination, making them indispensable tools in both primary and secondary endodontic procedures [9, 10]. Raypex (Raypex 6, VDW GmbH, Munich, Germany) is another widely used electronic apex locator (EAL). Aydın et al. [11] demonstrated that Raypex 6 showed success rates of 85% and 95% within ±0.5 mm and ±1 mm, respectively, in teeth with mature apices. Although apex locators function with the same principle, the areas detected by different devices may differ. These variations in apical measurements among different EALs may not only affect treatment accuracy but could also influence the extent of postoperative pain experienced by the patient.
Postoperative pain is a significant concern in endodontics, with its incidence ranging from 3% to 58% [12]. Irritation of periradicular tissues during root canal treatment induces an acute inflammatory response, leading to the release of chemical mediators and changes in local pressure and tissue adaptation [13]. Accurate WL determination plays a critical role in minimizing postoperative pain [14]. Although the use of electronic EALs in WL determination during root canal treatment has been widely accepted, there are only a limited number of clinical studies investigating their effect on postoperative pain. Recent studies have explored the clinical performance and accuracy of different EALs; however, their focus was primarily on measurement precision rather than postoperative outcomes like pain or patient comfort [7, 15].
Despite the increasing use of EALs in endodontic procedures, there is currently no clinical study that examines the impact of using different apex locator devices on postoperative pain in the nonsurgical endodontic retreatment. Given the added complexity of retreatment cases, such as the need to remove previous obturation materials and the potential for greater periapical irritation, this represents a significant gap in the literature. The primary aim of this randomized clinical study is to evaluate and compare the effect of WL determination using different apex locator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ProPex Pixi Apex Locator | Experimental | Device: determination of working length |
| Root ZX Apex Locator | Experimental | Device: determination of working length |
| Raypex 6 Apex Locator | Experimental | Device: determination of working length |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. ASA I or II individuals aged 18-60 years 2. Single-rooted, single-canaled teeth treated with root canal therapy ≥4 years ago 3. Root canal fillings ending 2-3 mm short of the radiographic apex 4. Diagnosis of asymptomatic apical periodontitis 5. Periapical Index (PAI) score of 2-4 [17], with no periodontal or prosthetic treatment needs 6. Root canal curvature <30° 7. Radiographically confirmed complete root formation and absence of resorption 8. Ability to achieve rubber dam isolation during treatment 9. Voluntary participation with signed informed consent
Key exclusion criteria (1 listed)
- 1. Use of analgesics, antibiotics, or corticosteroids within the past two weeks 2. Periodontal attachment loss (probing depth > 4 mm) 3. Teeth with vertical root fractures, external resorption, or perforations 4. Teeth with fractured instruments inside the root canal system 5. Severe root curvature or excessive coronal destruction on preoperative radiographs 6. Canal calcification, root resorption, or incomplete root development 7. Cognitive impairment, mental retardation, or inability to comply due to old age 8. Pregnancy or lactation 9. Presence of systemic conditions (e.g., widespread infection, cancer, cardiovascular disease, advanced diabetes)
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 |
|---|---|---|
| determination of working lengthCompare the effect of WL determination using different apex locator devices (ProPex Pixi, Root ZX, and Raypex 6) on the incidence and intensity of postoperative pain following endodontic retreatment in single-rooted teeth | Device | ProPex Pixi Apex Locator, Raypex 6 Apex Locator, Root ZX Apex Locator |
Primary outcome
Postoperative Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: From 6 hours up to 7 days after endodontic retreatment
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 100-mm line where patients mark their pain level. VAS scores will be categorized as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Patients will record their pain at 6, 12, and 24 hours postoperatively, and daily for up to 7 days following endodontic retreatment. Pain scores will be compared among the three apex locator groups (ProPex Pixi, Root ZX, Raypex 6) to assess the impact of different devices on postoperative pain levels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing determination of working length in people with Retreatment, run by Ipek Eraslan Akyuz.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: From 6 hours up to 7 days after endodontic retreatment). 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 9 May 2025.