Postoperative Acute PainNCT07271797
Comparing Different Electronic Apex Locators and Periapical Radiography on Postoperative Pain
A study testing Root ZX (Morita Corp., Tokyo, Japan), Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) and Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) in people with Postoperative Acute Pain, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study was conducted to better understand whether the method used to measure the length of root canals affects the amount of pain patients feel after root canal treatment. Accurate measurement of the root canal is important to clean and fill the tooth properly. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Acute Pain
- What is being tested?
- Root ZX (Morita Corp., Tokyo, Japan), Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) and Woodpex III (Woodpecker Medical Instrument Co., Guilin, China)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must meet all of the following criteria to be included in the trial:
- Aged between 18 and 60 years.
- Diagnosed with asymptomatic irreversible pulpitis in a single-rooted tooth and scheduled for primary root canal treatment in that tooth.
- In good general health, with no systemic diseases.
- No use of any analgesic medications within the last 24 hours prior to the treatment.
- Willing to participate in the study and able to give informed consent.
Who cannot join
- Patients who do not meet the above inclusion criteria excluded from the study. In other words, any patient outside the specified age range, with systemic health issues, having taken pain medication recently, or without an asymptomatic single-rooted tooth diagnosis as described, not enrolled. Additionally, patients who decline to participate or who cannot provide informed consent excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Different Electronic Apex Locators and Periapical Radiography on Postoperative Pain: A Randomized Clinical Study
This clinical study was conducted to better understand whether the method used to measure the length of root canals affects the amount of pain patients feel after root canal treatment. Accurate measurement of the root canal is important to clean and fill the tooth properly. If the canal is cleaned too short or too far, it may cause discomfort or reduce the success of the treatment.The study included 125 adult patients who had deep decay but no current pain or swelling. All had single-rooted teeth diagnosed with asymptomatic irreversible pulpitis. Participants were randomly divided into five groups, each using a different method to measure the root canal length before treatment. Four of the methods used electronic devices (called apex locators), and one used a dental X-ray. None of the patients knew which method was used in their case, and all treatments were done by the same dentist in a single appointment.Pain levels were recorded using a simple pain scale called the Visual Analog Scale (VAS), where patients marked their pain level at 6, 12, 24, and 48 hours after treatment. Patients were also allowed to take painkillers if needed, and they were asked to record how many tablets they used.The study also looked at factors like age, gender, the location of the treated tooth, and use of pain medication. The study was carried out at Bezmialem Vakif University's Department of Endodontics. All participants gave written consent, and the study was approved by the university's ethics committee. No complications or serious side effects were reported during or after the treatment.
Read the detailed description
This clinical study aimed to investigate whether the method used to determine root canal length has an effect on postoperative pain following root canal treatment. Accurate measurement of the root canal is crucial for successful cleaning and sealing of the root system. If the measurement is too short or too long, it may lead to discomfort or compromise treatment outcomes.
The study enrolled 125 adult patients who had deep dental caries but were not experiencing any active pain or swelling at the time of diagnosis. All patients had single-rooted teeth diagnosed with asymptomatic irreversible pulpitis, a condition in which the pulp is irreversibly damaged but does not yet cause symptoms. Eligible participants were randomly assigned to one of five groups, each using a different method for working length determination prior to treatment. Four groups used electronic apex locators (Root ZX, Propex Pixi, Woodpex III, and Raypex 6), while one group used periapical radiography (dental X-ray). Treatments were carried out by the same experienced clinician during a single appointment. Patients were blinded to the method used in their treatment.
To evaluate postoperative discomfort, pain levels were assessed using the Visual Analog Scale (VAS), a 10-centimeter scale where patients mark their pain level ranging from "no pain" to "worst imaginable pain." VAS scores were recorded at 6, 12, 24, and 48 hours after treatment. Patients were allowed to take over-the-counter pain medication (400 mg ibuprofen) if necessary, and they were instructed to record how many tablets they took each day.
In addition to pain levels, the study evaluated other potential contributing factors such as patient age, gender, the location of the treated tooth (upper or lower jaw), and use of analgesics. The data were analyzed to determine whether these factors were associated with differences in pain perception among groups.
This study was conducted at the Department of Endodontics, Faculty of Dentistry, Bezmialem Vakif University (Istanbul, Türkiye). Written informed consent was obtained from all participants, and the study protocol was approved by the university's ethics committee. No adverse events or complications were reported during or after the procedures.
- Conditions
- Postoperative Acute Pain
- Being tested
- Root ZX (Morita Corp., Tokyo, Japan), Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland), Woodpex III (Woodpecker Medical Instrument Co., Guilin, China), Raypex 6 (VDW, Munich, Germany), periapical radiography
- Keywords
- electronic apex locator, working length, postoperative pain, root canal therapy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root ZX (Morita Corp., Tokyo, Japan)Device
Root ZX (Morita Corp., Tokyo, Japan) is a well-established electronic apex locator widely used in endodontics for determining working length during root canal procedures. It operates based on the ratio method and has been shown to provide reliable and accurate measurements even in the presence of various irrigants. Root ZX has been extensively validated in clinical and laboratory studies and is considered a gold standard among apex locators.
Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland)Device
Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) is a compact electronic apex locator designed to determine the working length of root canals with high accuracy. It uses advanced multi-frequency technology to detect the position of the apical foramen and provides real-time feedback through visual and audible signals. Despite its small size, Propex Pixi has demonstrated reliable performance in various clinical settings.
Woodpex III (Woodpecker Medical Instrument Co., Guilin, China)Device
Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) is an electronic apex locator that operates using dual-frequency impedance technology to determine the working length of root canals. It features a user-friendly interface with visual and audible indicators, making it suitable for routine clinical use. While it is considered a cost-effective alternative to premium apex locators, studies have shown variable accuracy depending on canal conditions and the presence of irrigants.
Raypex 6 (VDW, Munich, Germany)Device
Raypex 6 (VDW, Munich, Germany) is a modern electronic apex locator that utilizes multi-frequency technology to accurately detect the apical constriction during root canal procedures. It features a color-coded graphical display and audible signals to guide clinicians throughout the procedure. Raypex 6 has been reported to provide reliable working length measurements even under challenging clinical conditions.
periapical radiographyDevice
Working length determination using periapical radiography involves placing a small endodontic file inside the root canal and taking a radiograph to estimate the position of the file tip relative to the root apex. This traditional technique is widely used but may be limited by image distortion, anatomical variations, and the two-dimensional nature of radiographs. Despite its limitations, it remains a common reference method in endodontic practice.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Identifies patients who underwent root canal treatment using Root ZX (Morita Corp., Tokyo, Japan) Receives: Device: Root ZX (Morita Corp., Tokyo, Japan) |
| Group 2 | Experimental | Identifies patients who underwent root canal treatment using Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) Receives: Device: Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) |
| Group 3 | Experimental | Identifies patients who underwent root canal treatment using Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) Receives: Device: Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) |
| Group 4 | Experimental | Identifies patients who underwent root canal treatment using Raypex 6 (VDW, Munich, Germany) Receives: Device: Raypex 6 (VDW, Munich, Germany) |
| Group 5 | Experimental | Describe patients who underwent root canal treatment using periapical radiography. Receives: Device: periapical radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Patient-reported pain intensity on the 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Higher scores indicate greater pain intensity. Pain levels were recorded by each participant in a diary. The analysis compares mean VAS scores among groups treated with different electronic apex locators.
Measured: 6, 12, 24, 48 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Acute PainStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Randomized, single-centre endodontic trial; single visit treatment; differeant electronic apex locators.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271797
- Sponsor's protocol ID
- 20210816
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nalci Calik G, Alim Uysal BA, Peker FB, Guneser MB. Evaluation of postoperative pain associated with different working length determination methods: a randomised clinical study. BMC Oral Health. 2026 Aug 8;26(1):1665. doi: 10.1186/s12903-026-09451-8.
PubMed 42698074
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Electronic Apex Locators and Periapical Radiography on Postoperative Pain: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07271797
- Acronym / sponsor ID
- 20210816
- Conditions
- Postoperative Acute Pain
- Keywords
- electronic apex locator, working length, postoperative pain, root canal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 9 Dec 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.
This clinical study was conducted to better understand whether the method used to measure the length of root canals affects the amount of pain patients feel after root canal treatment. Accurate measurement of the root canal is important to clean and fill the tooth properly. If the canal is cleaned too short or too far, it may cause discomfort or reduce the success of the treatment.The study included 125 adult patients who had deep decay but no current pain or swelling. All had single-rooted teeth diagnosed with asymptomatic irreversible pulpitis. Participants were randomly divided into five groups, each using a different method to measure the root canal length before treatment. Four of the methods used electronic devices (called apex locators), and one used a dental X-ray. None of the patients knew which method was used in their case, and all treatments were done by the same dentist in a single appointment.Pain levels were recorded using a simple pain scale called the Visual Analog Scale (VAS), where patients marked their pain level at 6, 12, 24, and 48 hours after treatment. Patients were also allowed to take painkillers if needed, and they were asked to record how many tablets they used.The study also looked at factors like age, gender, the location of the treated tooth, and use of pain medication. The study was carried out at Bezmialem Vakif University's Department of Endodontics. All participants gave written consent, and the study was approved by the university's ethics committee. No complications or serious side effects were reported during or after the treatment.
Detailed description
This clinical study aimed to investigate whether the method used to determine root canal length has an effect on postoperative pain following root canal treatment. Accurate measurement of the root canal is crucial for successful cleaning and sealing of the root system. If the measurement is too short or too long, it may lead to discomfort or compromise treatment outcomes.
The study enrolled 125 adult patients who had deep dental caries but were not experiencing any active pain or swelling at the time of diagnosis. All patients had single-rooted teeth diagnosed with asymptomatic irreversible pulpitis, a condition in which the pulp is irreversibly damaged but does not yet cause symptoms. Eligible participants were randomly assigned to one of five groups, each using a different method for working length determination prior to treatment. Four groups used electronic apex locators (Root ZX, Propex Pixi, Woodpex III, and Raypex 6), while one group used periapical radiography (dental X-ray). Treatments were carried out by the same experienced clinician during a single appointment. Patients were blinded to the method used in their treatment.
To evaluate postoperative discomfort, pain levels were assessed using the Visual Analog Scale (VAS), a 10-centimeter scale where patients mark their pain level ranging from "no pain" to "worst imaginable pain." VAS scores were recorded at 6, 12, 24, and 48 hours after treatment. Patients were allowed to take over-the-counter pain medication (400 mg ibuprofen) if necessary, and they were instructed to record how many tablets they took each day.
In addition to pain levels, the study evaluated other potential contributing factors such as patient age, gender, the location of the treated tooth (upper or lower jaw), and use of analgesics. The data were analyzed to determine whether these factors were associated with differences in pain perception among groups.
This study was conducted at the Department of Endodontics, Faculty of Dentistry, Bezmialem Vakif University (Istanbul, Türkiye). Written informed consent was obtained from all participants, and the study protocol was approved by the university's ethics committee. No adverse events or complications were reported during or after the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized, single-centre endodontic trial; single visit treatment; differeant electronic apex locators.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Root ZX (Morita Corp., Tokyo, Japan)Identifies patients who underwent root canal treatment using Root ZX (Morita Corp., Tokyo, Japan) |
| Group 2 | Experimental | Device: Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland)Identifies patients who underwent root canal treatment using Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) |
| Group 3 | Experimental | Device: Woodpex III (Woodpecker Medical Instrument Co., Guilin, China)Identifies patients who underwent root canal treatment using Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) |
| Group 4 | Experimental | Device: Raypex 6 (VDW, Munich, Germany)Identifies patients who underwent root canal treatment using Raypex 6 (VDW, Munich, Germany) |
| Group 5 | Experimental | Device: periapical radiographyDescribe patients who underwent root canal treatment using periapical radiography. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients must meet all of the following criteria to be included in the trial:
- Aged between 18 and 60 years.
- Diagnosed with asymptomatic irreversible pulpitis in a single-rooted tooth and scheduled for primary root canal treatment in that tooth.
- In good general health, with no systemic diseases.
- No use of any analgesic medications within the last 24 hours prior to the treatment.
Key exclusion criteria (1 listed)
- Patients who do not meet the above inclusion criteria excluded from the study. In other words, any patient outside the specified age range, with systemic health issues, having taken pain medication recently, or without an asymptomatic single-rooted tooth diagnosis as described, not enrolled. Additionally, patients who decline to participate or who cannot provide informed consent excluded.
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 ZX (Morita Corp., Tokyo, Japan)Root ZX (Morita Corp., Tokyo, Japan) is a well-established electronic apex locator widely used in endodontics for determining working length during root canal procedures. It operates based on the ratio method and has been shown to provide reliable and accurate measurements even in the presence of various irrigants. Root ZX has been extensively validated in clinical and laboratory studies and is considered a gold standard among apex locators. | Device | Group 1 |
| Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland)Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) is a compact electronic apex locator designed to determine the working length of root canals with high accuracy. It uses advanced multi-frequency technology to detect the position of the apical foramen and provides real-time feedback through visual and audible signals. Despite its small size, Propex Pixi has demonstrated reliable performance in various clinical settings. | Device | Group 2 |
| Woodpex III (Woodpecker Medical Instrument Co., Guilin, China)Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) is an electronic apex locator that operates using dual-frequency impedance technology to determine the working length of root canals. It features a user-friendly interface with visual and audible indicators, making it suitable for routine clinical use. While it is considered a cost-effective alternative to premium apex locators, studies have shown variable accuracy depending on canal conditions and the presence of irrigants. | Device | Group 3 |
| Raypex 6 (VDW, Munich, Germany)Raypex 6 (VDW, Munich, Germany) is a modern electronic apex locator that utilizes multi-frequency technology to accurately detect the apical constriction during root canal procedures. It features a color-coded graphical display and audible signals to guide clinicians throughout the procedure. Raypex 6 has been reported to provide reliable working length measurements even under challenging clinical conditions. | Device | Group 4 |
| periapical radiographyWorking length determination using periapical radiography involves placing a small endodontic file inside the root canal and taking a radiograph to estimate the position of the file tip relative to the root apex. This traditional technique is widely used but may be limited by image distortion, anatomical variations, and the two-dimensional nature of radiographs. Despite its limitations, it remains a common reference method in endodontic practice. | Device | Group 5 |
Primary outcome
Postoperative pain intensity
Time frame: 6, 12, 24, 48 hours after root canal treatment
Patient-reported pain intensity on the 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Higher scores indicate greater pain intensity. Pain levels were recorded by each participant in a diary. The analysis compares mean VAS scores among groups treated with different electronic apex locators.
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 9 Dec 2025.
- Derived from this study: PubMed 42698074Nalci Calik G, Alim Uysal BA, Peker FB, Guneser MB. Evaluation of postoperative pain associated with different working length determination methods: a randomised clinical study. BMC Oral Health. 2026 Aug 8;26(1):1665. doi: 10.1186/s12903-026-09451-8.
- 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. 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 Root ZX (Morita Corp., Tokyo, Japan), Propex Pixi (Dentsply Maillefer, Ballaigues, Switzerland) and Woodpex III (Woodpecker Medical Instrument Co., Guilin, China) in people with Postoperative Acute Pain, run by Bezmialem Vakif 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 6 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
Postoperative pain intensity (time frame: 6, 12, 24, 48 hours after root canal treatment). 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 NCT07271797, which also lists 1 linked publication.
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 Dec 2025.