Postoperative Pain After Endodontic TreatmentNCT07233590
The Effect of Apical Patency on Postoperative Pain Following Root Canal Treatment
A study testing Root canal treatment with apical patency and Root canal treatment without apical patency in people with Postoperative Pain After Endodontic Treatment, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled clinical trial was to evaluate whether implementing apical patency affects the intensity of postoperative pain after single-visit root canal treatment in asymptomatic, vital, single-rooted teeth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain After Endodontic Treatment
- What is being tested?
- Root canal treatment with apical patency and Root canal treatment without apical patency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2024to 10 Feb 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
- Individuals aged 18-65 years, classified as ASA I or ASA II according to the American Society of Anesthesiologists (ASA), who had not taken analgesics for at least 6 hours prior to treatment.
- Asymptomatic, single-rooted vital teeth without spontaneous pain (including teeth perforated during prosthetic preparation or teeth adjacent to a cyst in an area scheduled for cyst surgery).
- Radiographic evidence of mature apices with no periapical pathology; periodontal probing depth ≤ 3 mm; and gingival health meeting Glickman's criteria.
- Individuals who are literate, able to provide written informed consent, and capable of understanding and using the pain scale.
Who cannot join
- Patients who are pregnant or have a cardiac pacemaker.
- Patients who used antibiotics within the past month or who required antibiotic prophylaxis.
- Presence of extensive restorations in the tooth of interest.
- Patients reporting concurrent pain in adjacent teeth.
- Dental or orofacial pain of non-endodontic origin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Apical Patency on Postoperative Pain Following Root Canal Treatment of Single-Rooted Teeth: A Randomized Controlled Clinical Trial
The goal of this randomized controlled clinical trial was to evaluate whether implementing apical patency affects the intensity of postoperative pain after single-visit root canal treatment in asymptomatic, vital, single-rooted teeth.
The main question it aims to answer is:
Read more
Does maintaining apical patency by gently extending a #10 K-file 1 mm beyond the working length during canal shaping influence postoperative pain compared with instrumentation confined within the working length?
In the patency group, the working length was determined with an electronic apex locator and radiograph, and then apical patency was maintained by passively extending a #10 K-file 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus.
In the non-patency group, the working length was likewise established with an electronic apex locator and radiograph, but all subsequent instrumentation was confined within the working length and no file was advanced beyond the apical foramen.
In both groups, all other clinical procedures-including anesthesia, rubber dam isolation, access cavity preparation, rotary canal shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation with gutta-percha and epoxy resin-based sealer, and definitive composite restoration-were performed in a single visit using the same protocol. Postoperative pain was recorded on a Numerical Rating Scale (NRS) at 0-6, 6-12, 12-24, 24-36, and 36-48 hours, and analgesic intake within 48 hours was documented.
- Being tested
- Root canal treatment with apical patency, Root canal treatment without apical patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment with apical patencyProcedure or surgery
Single-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is maintained. After working length determination with an electronic apex locator and radiographic confirmation, a #10 K-file is gently extended 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow a standardized protocol.
Root canal treatment without apical patencyProcedure or surgery
Single-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is not maintained. After working length determination with an electronic apex locator and radiographic confirmation, all subsequent instrumentation is confined within the working length and no file is advanced beyond the apical foramen. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow the same standardized protocol as in the patency group.
| Study group | Role | What they receive |
|---|---|---|
| Non-Patency Group | Active comparator | Preoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs.
The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was not maintained: after working length determination, all subsequent instrumentation was confined within the working length, and no file was advanced beyond the apical foramen.
Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochlorite (2 mL after each shaping step) de Receives: Procedure: Root canal treatment without apical patency |
| Patency Group | Experimental | Preoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs.
The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was maintained: a #10 K-file was gently advanced 1 mm beyond the working length at each instrument change to prevent apical blockage, remove accumulated debris, and facilitate irrigant delivery to the apical terminus.
Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochl Receives: Procedure: Root canal treatment with apical patency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
The numerical rating scale for pain is an 11-point scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. The patient is asked to choose the number that best represents the intensity of pain he or she feels at that moment. It is used to assess the severity of postoperative pain and to help evaluate the need for and response to analgesic medication. Also called NRS.
Measured: Up to 48 hours after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start5 Oct 2024
- Primary completion14 Dec 2024
- Study completion10 Feb 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 Pain After Endodontic TreatmentStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
- Investigators
- Adile Şehnaz Yılmaz, DDS, Phd, Professor, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233590
- Sponsor's protocol ID
- 10.05.2024/33
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yaylali IE, Demirci GK, Kurnaz S, Celik G, Kaya BU, Tunca YM. Does Maintaining Apical Patency during Instrumentation Increase Postoperative Pain or Flare-up Rate after Nonsurgical Root Canal Treatment? A Systematic Review of Randomized Controlled Trials. J Endod. 2018 Aug;44(8):1228-1236. doi: 10.1016/j.joen.2018.05.002. Epub 2018 Jun 20.
PubMed 29935875
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Apical Patency on Postoperative Pain Following Root Canal Treatment of Single-Rooted Teeth: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07233590
- Acronym / sponsor ID
- 10.05.2024/33
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 18 Nov 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.
The goal of this randomized controlled clinical trial was to evaluate whether implementing apical patency affects the intensity of postoperative pain after single-visit root canal treatment in asymptomatic, vital, single-rooted teeth.
The main question it aims to answer is:
Does maintaining apical patency by gently extending a #10 K-file 1 mm beyond the working length during canal shaping influence postoperative pain compared with instrumentation confined within the working length?
In the patency group, the working length was determined with an electronic apex locator and radiograph, and then apical patency was maintained by passively extending a #10 K-file 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus.
In the non-patency group, the working length was likewise established with an electronic apex locator and radiograph, but all subsequent instrumentation was confined within the working length and no file was advanced beyond the apical foramen.
In both groups, all other clinical procedures-including anesthesia, rubber dam isolation, access cavity preparation, rotary canal shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation with gutta-percha and epoxy resin-based sealer, and definitive composite restoration-were performed in a single visit using the same protocol. Postoperative pain was recorded on a Numerical Rating Scale (NRS) at 0-6, 6-12, 12-24, 24-36, and 36-48 hours, and analgesic intake within 48 hours was documented.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Patency Group | Active comparator | Procedure: Root canal treatment without apical patencyPreoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs. The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was not maintained: after working length determination, all subsequent instrumentation was confined within the working length, and no file was advanced beyond the apical foramen. Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochlorite (2 mL after each shaping step) de |
| Patency Group | Experimental | Procedure: Root canal treatment with apical patencyPreoperative pain was recorded using a Numerical Rating Scale (NRS) before treatment. All procedures were performed in a single visit by one operator under 3× magnification. Local anesthesia was achieved with 4% articaine containing 1:100,000 epinephrine. After rubber dam isolation, caries and existing restorations were removed and an endodontic access cavity was prepared under copious water cooling using high-speed sterile diamond burs. The working length was established with an electronic apex locator (Root ZX Mini) and confirmed radiographically. In this group, apical patency was maintained: a #10 K-file was gently advanced 1 mm beyond the working length at each instrument change to prevent apical blockage, remove accumulated debris, and facilitate irrigant delivery to the apical terminus. Root canals were shaped using the One Curve NiTi rotary system (25/.06 or 35/.04) with a crown-down technique. During shaping, canals were irrigated with a total of 10 mL of 2.5% sodium hypochl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18-65 years, classified as ASA I or ASA II according to the American Society of Anesthesiologists (ASA), who had not taken analgesics for at least 6 hours prior to treatment.
- Asymptomatic, single-rooted vital teeth without spontaneous pain (including teeth perforated during prosthetic preparation or teeth adjacent to a cyst in an area scheduled for cyst surgery).
- Radiographic evidence of mature apices with no periapical pathology; periodontal probing depth ≤ 3 mm; and gingival health meeting Glickman's criteria.
- Individuals who are literate, able to provide written informed consent, and capable of understanding and using the pain scale.
Key exclusion criteria (5 listed)
- Patients who are pregnant or have a cardiac pacemaker.
- Patients who used antibiotics within the past month or who required antibiotic prophylaxis.
- Presence of extensive restorations in the tooth of interest.
- Patients reporting concurrent pain in adjacent teeth.
- Dental or orofacial pain of non-endodontic origin.
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 treatment with apical patencySingle-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is maintained. After working length determination with an electronic apex locator and radiographic confirmation, a #10 K-file is gently extended 1 mm beyond the working length at each instrument change to prevent apical blockage, remove debris, and facilitate irrigant delivery to the apical terminus. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow a standardized protocol. | Procedure or surgery | Patency Group |
| Root canal treatment without apical patencySingle-visit root canal treatment of asymptomatic vital single-rooted teeth in which apical patency is not maintained. After working length determination with an electronic apex locator and radiographic confirmation, all subsequent instrumentation is confined within the working length and no file is advanced beyond the apical foramen. All other steps, including anesthesia, rubber dam isolation, access cavity preparation, rotary shaping with the One Curve NiTi system, standardized irrigation with 2.5% NaOCl and 17% EDTA, obturation, and definitive composite restoration, follow the same standardized protocol as in the patency group. | Procedure or surgery | Non-Patency Group |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Up to 48 hours after treatment.
The numerical rating scale for pain is an 11-point scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. The patient is asked to choose the number that best represents the intensity of pain he or she feels at that moment. It is used to assess the severity of postoperative pain and to help evaluate the need for and response to analgesic medication. Also called NRS.
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 18 Nov 2025.
- Background: PubMed 29935875Yaylali IE, Demirci GK, Kurnaz S, Celik G, Kaya BU, Tunca YM. Does Maintaining Apical Patency during Instrumentation Increase Postoperative Pain or Flare-up Rate after Nonsurgical Root Canal Treatment? A Systematic Review of Randomized Controlled Trials. J Endod. 2018 Aug;44(8):1228-1236. doi: 10.1016/j.joen.2018.05.002. Epub 2018 Jun 20.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain After Endodontic Treatment
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
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.
Adile Şehnaz Yılmaz, DDS, Phd, Professor principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal treatment with apical patency and Root canal treatment without apical patency in people with Postoperative Pain After Endodontic Treatment, run by Cukurova 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 4 inclusion and 5 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 18 Nov 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?
Numerical Rating Scale (NRS) (time frame: Up to 48 hours 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 NCT07233590, 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 18 Nov 2025.