Apical PeriodontitisNCT07714733
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
A study testing Root Canal Treatment, Rotary Instrumentation and Reciprocating Instrumentation in people with Apical Periodontitis and Postoperative Pain After Endodontic Treatment, run by Alanya Alaaddin Keykubat University.
Trial summary
Brief Summary This prospective, randomized clinical trial aims to evaluate the effect of different endodontic motor settings used during root canal treatment on postoperative pain. During root canal treatment, the inner part of the tooth is cleaned and shaped using specialized rotating instruments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Apical Periodontitis, Postoperative Pain After Endodontic Treatment
- What is being tested?
- Root Canal Treatment, Rotary Instrumentation and Reciprocating Instrumentation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 15 Mar 2027
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years
- Systemically healthy individuals (ASA I)
- Mandibular premolar teeth diagnosed with chronic apical periodontitis
- Periapical Index (PAI) score ≥ 3 confirmed radiographically
- Teeth indicated for single-visit root canal treatment
- Patients able to understand and complete the Visual Analog Scale (VAS)
- Written informed consent provided
Who cannot join
- Patients with systemic diseases or medically compromised conditions
- Pregnant or breastfeeding women
- Patients with uncontrolled diabetes mellitus
- Use of analgesics or antibiotics within the previous 7 days
- Teeth with root resorption
- Teeth with immature apices
- Previously endodontically treated teeth
- Patients unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Using A Single Nickel-Titanium File System With Rotary And Reciprocation Kinematics in Different Apical Motion Modes on Postoperative Pain After Root Canal Treatment
Brief Summary
This prospective, randomized clinical trial aims to evaluate the effect of different endodontic motor settings used during root canal treatment on postoperative pain.
Read more
During root canal treatment, the inner part of the tooth is cleaned and shaped using specialized rotating instruments. These instruments can operate with different motion patterns, and the motor may respond differently as the instrument approaches the tip of the root. The influence of these technical variations on postoperative pain has not been clearly established.
Adult participants requiring root canal treatment for mandibular premolar teeth will be enrolled in the study. Participants will be randomly assigned to different groups. In each group, root canal treatment will be performed using different motor motion settings. All procedures applied in this study are routine and safe treatment methods commonly used in clinical endodontic practice.
After treatment, participants' pain levels will be monitored through telephone follow-ups. Pain intensity will be assessed using the Visual Analog Scale (VAS). In addition, analgesic intake will be recorded.
The purpose of this study is to determine whether different endodontic motor settings influence postoperative pain and patient comfort following root canal treatment. The findings are expected to contribute to safer and more comfortable root canal treatment protocols.
Read the detailed description
Detailed Description
Postoperative pain remains one of the most relevant short-term outcomes in endodontic treatment and may be influenced by several mechanical and biological factors during root canal preparation. Among these factors, the kinematics of nickel-titanium instrumentation systems and the apical motion algorithms integrated into endodontic motors may affect debris extrusion, apical stress, and periapical tissue irritation. Although different motor settings are routinely used in clinical practice, the influence of these apical motion modes on postoperative pain has not been sufficiently clarified.
This prospective, randomized, double-blind clinical trial is designed to investigate the effect of different apical motion algorithms used during root canal treatment on postoperative pain. The study will focus on mandibular premolar teeth diagnosed with chronic apical periodontitis and requiring primary root canal treatment. Participants will be randomly assigned to one of six treatment groups according to the kinematic system used during canal preparation (rotary or reciprocating) and the apical motion mode of the endodontic motor (auto apical stop, auto apical reverse, or off mode).
All treatments will be performed by the investigator using a standardized clinical protocol under local anesthesia and rubber dam isolation. Working length determination, irrigation, ultrasonic activation, canal preparation, obturation, and coronal restoration procedures will be standardized in order to minimize operator- and technique-related variability. A single nickel-titanium file system will be used in all groups to reduce the confounding effect of instrument design.
The main purpose of this study is to determine whether the use of different apical motion modes, under rotary and reciprocating kinematics, results in differences in postoperative pain intensity. In addition, the study seeks to provide clinically relevant evidence regarding whether these motor settings influence patient comfort after treatment. The findings are expected to contribute to the optimization of endodontic instrumentation protocols and to support more evidence-based selection of motor settings in daily clinical practice.
- Being tested
- Root Canal Treatment, Rotary Instrumentation, Reciprocating Instrumentation, Auto Apical Stop Mode, Auto Apical Reverse Mode
- Keywords
- Endodontics, Root Canal Treatment, Postoperative Pain, Apical Motion, Rotary Nicel Titanium File, Reciprocating Nickel-Titanium File
- 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.
Root Canal TreatmentProcedure or surgery
Standardized primary root canal treatment performed under local anesthesia and rubber dam isolation.
Rotary InstrumentationDevice
Canal preparation performed using continuous rotary motion.
Reciprocating InstrumentationDevice
Canal preparation performed using reciprocating motion.
Auto Apical Stop ModeDevice
Endodontic motor operated with the auto apical stop mode activated.
Auto Apical Reverse ModeDevice
Endodontic motor operated with the auto apical reverse mode activated.
Apical Off ModeDevice
Endodontic motor operated with the apical action mode turned off.
| Study group | Role | What they receive |
|---|---|---|
| Rotary + Apical Stop | Experimental | Participants receive root canal treatment using continuous rotary instrumentation with the auto apical stop function activated. Receives: Procedure: Root Canal Treatment; Device: Rotary Instrumentation; Device: Auto Apical Stop Mode |
| Rotary + Apical Reverse | Experimental | Participants receive root canal treatment using continuous rotary instrumentation with the auto apical reverse function activated. Receives: Procedure: Root Canal Treatment; Device: Rotary Instrumentation; Device: Auto Apical Reverse Mode |
| Rotary + Apical Off | Experimental | Participants receive root canal treatment using continuous rotary instrumentation with the apical action mode turned off. Receives: Procedure: Root Canal Treatment; Device: Rotary Instrumentation; Device: Apical Off Mode |
| Reciprocating + Apical Stop | Experimental | Participants receive root canal treatment using reciprocating instrumentation with the auto apical stop function activated. Receives: Procedure: Root Canal Treatment; Device: Reciprocating Instrumentation; Device: Auto Apical Stop Mode |
| Reciprocating + Apical Reverse | Experimental | Participants receive root canal treatment using reciprocating instrumentation with the auto apical reverse function activated. Receives: Procedure: Root Canal Treatment; Device: Reciprocating Instrumentation; Device: Auto Apical Reverse Mode |
| Reciprocating + Apical Off | Experimental | Participants receive root canal treatment using reciprocating instrumentation with the apical action mode turned off. Receives: Procedure: Root Canal Treatment; Device: Reciprocating Instrumentation; Device: Apical Off Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater postoperative pain intensity. The same outcome measure will be assessed repeatedly at predefined postoperative time points to evaluate changes in postoperative pain intensity over time.
Measured: Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after treatment.
Secondary outcomes (1)
Analgesic Intake
Analgesic intake will be assessed as the total number of analgesic tablets taken by each participant during the first 7 days after treatment.
Measured: Within 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1:1:1:1 ratio to one of six parallel treatment groups according to the instrumentation kinematics (rotary or reciprocating) and apical motion mode (auto apical stop, auto apical reverse, or off mode).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice BÜYÜKÖZER ÖZKAN, Alanya Alaaddin Keykubat University
- Investigators
- Hatice BÜYÜKÖZER ÖZKAN, Associate Professor, Principal investigator, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714733
- Sponsor's protocol ID
- ALKU-EC-2026-39
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions, institutional policies, and the requirements of the Turkish Personal Data Protection Law (Law No. 6698, KVKK). Participant confidentiality will be strictly protected, and the collected data will be used solely for the purposes of the approved study protocol.
Publications
Tulgar MM, Kilic Y, Karalar O, Yilmaz HE, Karataslioglu E. Inflammatory Mediator Levels and Postoperative Pain Following Root Canal Shaping with Different Apical Actions: A Randomized Controlled Trial. J Endod. 2026 Apr;52(4):574-581.e1. doi: 10.1016/j.joen.2025.12.005. Epub 2025 Dec 23.
PubMed 41448536Mendes WV, Lima SNL, do Nascimento Azevedo JV, Leite HLA, Oliveira PS, Ferreira MC, Carvalho CN. Postoperative pain and quality of life assessment after endodontic preparation with rotary and reciprocating endodontic instruments: randomized clinical trial. Trials. 2025 Feb 26;26(1):68. doi: 10.1186/s13063-025-08766-1.
PubMed 40001136Govindiah Chandra Mohan BG, Shivakumar D, Laxmi Penumaka S, Althaf S, Garg G, Kamatchi Subramani S. To Evaluate Different Endodontic Instrumentation Systems Regarding Post-Operative Pain After Endodontic Therapy: A Clinical Study. Cureus. 2024 Mar 19;16(3):e56466. doi: 10.7759/cureus.56466. eCollection 2024 Mar.
PubMed 38638716
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using A Single Nickel-Titanium File System With Rotary And Reciprocation Kinematics in Different Apical Motion Modes on Postoperative Pain After Root Canal Treatment
- ClinicalTrials.gov ID
- NCT07714733
- Acronym / sponsor ID
- ALKU-EC-2026-39
- Keywords
- Endodontics, Root Canal Treatment, Postoperative Pain, Apical Motion, Rotary Nicel Titanium File, Reciprocating Nickel-Titanium File
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 20 Jul 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.
Brief Summary
This prospective, randomized clinical trial aims to evaluate the effect of different endodontic motor settings used during root canal treatment on postoperative pain.
During root canal treatment, the inner part of the tooth is cleaned and shaped using specialized rotating instruments. These instruments can operate with different motion patterns, and the motor may respond differently as the instrument approaches the tip of the root. The influence of these technical variations on postoperative pain has not been clearly established.
Adult participants requiring root canal treatment for mandibular premolar teeth will be enrolled in the study. Participants will be randomly assigned to different groups. In each group, root canal treatment will be performed using different motor motion settings. All procedures applied in this study are routine and safe treatment methods commonly used in clinical endodontic practice.
After treatment, participants' pain levels will be monitored through telephone follow-ups. Pain intensity will be assessed using the Visual Analog Scale (VAS). In addition, analgesic intake will be recorded.
The purpose of this study is to determine whether different endodontic motor settings influence postoperative pain and patient comfort following root canal treatment. The findings are expected to contribute to safer and more comfortable root canal treatment protocols.
Detailed description
Detailed Description
Postoperative pain remains one of the most relevant short-term outcomes in endodontic treatment and may be influenced by several mechanical and biological factors during root canal preparation. Among these factors, the kinematics of nickel-titanium instrumentation systems and the apical motion algorithms integrated into endodontic motors may affect debris extrusion, apical stress, and periapical tissue irritation. Although different motor settings are routinely used in clinical practice, the influence of these apical motion modes on postoperative pain has not been sufficiently clarified.
This prospective, randomized, double-blind clinical trial is designed to investigate the effect of different apical motion algorithms used during root canal treatment on postoperative pain. The study will focus on mandibular premolar teeth diagnosed with chronic apical periodontitis and requiring primary root canal treatment. Participants will be randomly assigned to one of six treatment groups according to the kinematic system used during canal preparation (rotary or reciprocating) and the apical motion mode of the endodontic motor (auto apical stop, auto apical reverse, or off mode).
All treatments will be performed by the investigator using a standardized clinical protocol under local anesthesia and rubber dam isolation. Working length determination, irrigation, ultrasonic activation, canal preparation, obturation, and coronal restoration procedures will be standardized in order to minimize operator- and technique-related variability. A single nickel-titanium file system will be used in all groups to reduce the confounding effect of instrument design.
The main purpose of this study is to determine whether the use of different apical motion modes, under rotary and reciprocating kinematics, results in differences in postoperative pain intensity. In addition, the study seeks to provide clinically relevant evidence regarding whether these motor settings influence patient comfort after treatment. The findings are expected to contribute to the optimization of endodontic instrumentation protocols and to support more evidence-based selection of motor settings in daily clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants will be randomly assigned in a 1:1:1:1:1:1 ratio to one of six parallel treatment groups according to the instrumentation kinematics (rotary or reciprocating) and apical motion mode (auto apical stop, auto apical reverse, or off mode).
| Arm | Type | Receives |
|---|---|---|
| Rotary + Apical Stop | Experimental | Procedure: Root Canal Treatment, Device: Rotary Instrumentation, Device: Auto Apical Stop ModeParticipants receive root canal treatment using continuous rotary instrumentation with the auto apical stop function activated. |
| Rotary + Apical Reverse | Experimental | Procedure: Root Canal Treatment, Device: Rotary Instrumentation, Device: Auto Apical Reverse ModeParticipants receive root canal treatment using continuous rotary instrumentation with the auto apical reverse function activated. |
| Rotary + Apical Off | Experimental | Procedure: Root Canal Treatment, Device: Rotary Instrumentation, Device: Apical Off ModeParticipants receive root canal treatment using continuous rotary instrumentation with the apical action mode turned off. |
| Reciprocating + Apical Stop | Experimental | Procedure: Root Canal Treatment, Device: Reciprocating Instrumentation, Device: Auto Apical Stop ModeParticipants receive root canal treatment using reciprocating instrumentation with the auto apical stop function activated. |
| Reciprocating + Apical Reverse | Experimental | Procedure: Root Canal Treatment, Device: Reciprocating Instrumentation, Device: Auto Apical Reverse ModeParticipants receive root canal treatment using reciprocating instrumentation with the auto apical reverse function activated. |
| Reciprocating + Apical Off | Experimental | Procedure: Root Canal Treatment, Device: Reciprocating Instrumentation, Device: Apical Off ModeParticipants receive root canal treatment using reciprocating instrumentation with the apical action mode turned off. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-70 years
- Systemically healthy individuals (ASA I)
- Mandibular premolar teeth diagnosed with chronic apical periodontitis
- Periapical Index (PAI) score ≥ 3 confirmed radiographically
- Teeth indicated for single-visit root canal treatment
Key exclusion criteria (8 listed)
- Patients with systemic diseases or medically compromised conditions
- Pregnant or breastfeeding women
- Patients with uncontrolled diabetes mellitus
- Use of analgesics or antibiotics within the previous 7 days
- Teeth with root resorption
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 Canal TreatmentStandardized primary root canal treatment performed under local anesthesia and rubber dam isolation. | Procedure or surgery | Reciprocating + Apical Off, Reciprocating + Apical Reverse, Reciprocating + Apical Stop, Rotary + Apical Off, Rotary + Apical Reverse, Rotary + Apical Stop |
| Rotary InstrumentationCanal preparation performed using continuous rotary motion. | Device | Rotary + Apical Off, Rotary + Apical Reverse, Rotary + Apical Stop |
| Reciprocating InstrumentationCanal preparation performed using reciprocating motion. | Device | Reciprocating + Apical Off, Reciprocating + Apical Reverse, Reciprocating + Apical Stop |
| Auto Apical Stop ModeEndodontic motor operated with the auto apical stop mode activated. | Device | Reciprocating + Apical Stop, Rotary + Apical Stop |
| Auto Apical Reverse ModeEndodontic motor operated with the auto apical reverse mode activated. | Device | Reciprocating + Apical Reverse, Rotary + Apical Reverse |
| Apical Off ModeEndodontic motor operated with the apical action mode turned off. | Device | Reciprocating + Apical Off, Rotary + Apical Off |
Primary outcome
Postoperative Pain Intensity
Time frame: Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after treatment.
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater postoperative pain intensity. The same outcome measure will be assessed repeatedly at predefined postoperative time points to evaluate changes in postoperative pain intensity over time.
1 secondary outcome
Analgesic Intake
Time frame: Within 7 days after treatment
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 20 Jul 2026.
- Background: PubMed 41448536Tulgar MM, Kilic Y, Karalar O, Yilmaz HE, Karataslioglu E. Inflammatory Mediator Levels and Postoperative Pain Following Root Canal Shaping with Different Apical Actions: A Randomized Controlled Trial. J Endod. 2026 Apr;52(4):574-581.e1. doi: 10.1016/j.joen.2025.12.005. Epub 2025 Dec 23.
- Background: PubMed 40001136Mendes WV, Lima SNL, do Nascimento Azevedo JV, Leite HLA, Oliveira PS, Ferreira MC, Carvalho CN. Postoperative pain and quality of life assessment after endodontic preparation with rotary and reciprocating endodontic instruments: randomized clinical trial. Trials. 2025 Feb 26;26(1):68. doi: 10.1186/s13063-025-08766-1.
- Background: PubMed 38638716Govindiah Chandra Mohan BG, Shivakumar D, Laxmi Penumaka S, Althaf S, Garg G, Kamatchi Subramani S. To Evaluate Different Endodontic Instrumentation Systems Regarding Post-Operative Pain After Endodontic Therapy: A Clinical Study. Cureus. 2024 Mar 19;16(3):e56466. doi: 10.7759/cureus.56466. eCollection 2024 Mar.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions, institutional policies, and the requirements of the Turkish Personal Data Protection Law (Law No. 6698, KVKK). Participant confidentiality will be strictly protected, and the collected data will be used solely for the purposes of the approved study protocol.
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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.
Hatice BÜYÜKÖZER ÖZKAN, Associate Professor principal investigator
Alanya Alaaddin Keykubat University
Questions about this trial
What is this clinical trial studying?
A study testing Root Canal Treatment, Rotary Instrumentation and Reciprocating Instrumentation in people with Apical Periodontitis and Postoperative Pain After Endodontic Treatment, run by Alanya Alaaddin Keykubat University.
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 8 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 20 Jul 2026. 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.
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?
Contact Mehmet Sinan SİNECAN, Research Assistant (90 507 059 81 62, sinan.sinecan@alanya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Repeated measurements at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days after 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 NCT07714733, which also lists 3 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 20 Jul 2026.