Apical PeriodontitisNCT07782515
Apical Patency, Periapical Lesion Volume, and Postoperative Pain After Root Canal Treatment
A study testing Apical Patency During Root Canal Treatment and Root Canal Treatment Without Apical Patency in people with Apical Periodontitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study evaluated whether maintaining apical patency during single-visit root canal treatment influences postoperative pain in adults with single-rooted maxillary anterior teeth and chronic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Apical Patency During Root Canal Treatment 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
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2025to 25 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients.
- Systemically healthy and not using regular systemic medications.
- A single-rooted maxillary anterior tooth requiring primary root canal treatment.
- Diagnosis of chronic apical periodontitis in the study tooth.
- The tooth was restorable.
- Absence of root fracture or crack.
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- Absence of internal or external resorption.
- Root canal negotiable to the apical region with a small hand file.
- Ability to establish a reliable working length.
- Availability of a CBCT scan of the relevant maxillary anterior region, previously obtained for clinical purposes or indicated during the treatment process.
Who cannot join
- Pregnancy or breastfeeding.
- Previous endodontic treatment of the study tooth.
- Severe canal calcification.
- Suspected root fracture or crack.
- Internal or external root resorption.
- Periodontal probing depth of 5 mm or greater.
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- Previous surgical intervention in the relevant region.
- Inability to negotiate the root canal.
- Inability to establish a reliable working length.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics
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About this study
Official title: Effect of Apical Patency and Periapical Lesion Volume on Postoperative Pain: A CBCT-Based Volumetric Clinical Study
This prospective clinical study evaluated whether maintaining apical patency during single-visit root canal treatment influences postoperative pain in adults with single-rooted maxillary anterior teeth and chronic apical periodontitis. Participants were systematically allocated in consecutive order to treatment with apical patency or treatment without apical patency. The study also evaluated the relationship between baseline periapical lesion volume measured on clinically indicated cone-beam computed tomography images and postoperative pain.
Read the detailed description
Eligible participants received standardized single-visit root canal treatment under local anesthesia and rubber dam isolation. In the apical patency group, a #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument without intentional apical enlargement or dentin removal. In the no-apical-patency group, canal preparation was confined to the working length and no instrument was intentionally extended beyond the apical foramen. Conventional randomization was not used. To maintain numerical balance during enrolment, a systematic consecutive allocation approach was used, whereby apical patency was performed in one case and not performed in the subsequent case. Participants were aware of the treatment approach. Postoperative pain was assessed with a 100-mm visual analog scale at 8 hours, 24 hours, 3 days, 5 days, and 7 days. Analgesic use was also recorded. Periapical lesion volume was measured in cubic millimeters using manual three-dimensional segmentation with ITK-SNAP on eligible CBCT images obtained for clinical purposes.
- Conditions
- Apical Periodontitis
- Being tested
- Apical Patency During Root Canal Treatment, Root Canal Treatment Without Apical Patency
- Keywords
- Apical Patency, Postoperative Pain, Root Canal Treatment, Periapical Lesion, Cone-Beam Computed Tomography
- 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.
Apical Patency During Root Canal TreatmentProcedure or surgery
A #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument during standardized single-visit root canal treatment.
Root Canal Treatment Without Apical PatencyProcedure or surgery
Standardized single-visit root canal treatment was performed with instrumentation confined to the working length and without intentional passage of an instrument beyond the apical foramen.
| Study group | Role | What they receive |
|---|---|---|
| Apical Patency | Experimental | Participants received standardized single-visit root canal treatment. During canal preparation, a #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument to maintain apical patency. No intentional apical enlargement or dentin removal was performed. Receives: Procedure: Apical Patency During Root Canal Treatment |
| No Apical Patency | Active comparator | Participants received the same standardized single-visit root canal treatment, but canal preparation was confined to the working length and no instrument was intentionally extended beyond the apical foramen. Receives: Procedure: Root Canal Treatment Without Apical Patency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS), where 0 mm indicated no pain and 100 mm indicated unbearable pain. Participants recorded the highest pain experienced during each predefined postoperative interval.
Measured: 8 hours, 24 hours, 3 days, 5 days, and 7 days after root canal treatment
Secondary outcomes (2)
Number of Participants Who Used Any Postoperative Analgesic Medication
Participants were classified as having postoperative analgesic use if they reported taking at least one dose of any analgesic medication after root canal treatment during the 7-day follow-up period. The outcome was assessed as the number of participants with any postoperative analgesic use in each treatment arm.
Measured: From completion of root canal treatment through Day 7
Baseline Periapical Lesion Volume
Periapical lesion volume was measured in cubic millimeters (mm³) on clinically indicated pre-treatment CBCT scans using manual three-dimensional segmentation with ITK-SNAP software. One baseline lesion-volume value was obtained for each participant with an evaluable CBCT scan.
Measured: Baseline, before 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 posted24 Aug 2026
- Study start22 May 2025
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Pertek Hatipoğlu, Recep Tayyip Erdogan University
- Investigators
- Fatma Pertek Hatipoğlu, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782515
- Sponsor's protocol ID
- RTEU-ENDO-2025-330
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apical Patency and Periapical Lesion Volume on Postoperative Pain: A CBCT-Based Volumetric Clinical Study
- ClinicalTrials.gov ID
- NCT07782515
- Acronym / sponsor ID
- RTEU-ENDO-2025-330
- Conditions
- Apical Periodontitis
- Keywords
- Apical Patency, Postoperative Pain, Root Canal Treatment, Periapical Lesion, Cone-Beam Computed Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective clinical study evaluated whether maintaining apical patency during single-visit root canal treatment influences postoperative pain in adults with single-rooted maxillary anterior teeth and chronic apical periodontitis. Participants were systematically allocated in consecutive order to treatment with apical patency or treatment without apical patency. The study also evaluated the relationship between baseline periapical lesion volume measured on clinically indicated cone-beam computed tomography images and postoperative pain.
Detailed description
Eligible participants received standardized single-visit root canal treatment under local anesthesia and rubber dam isolation. In the apical patency group, a #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument without intentional apical enlargement or dentin removal. In the no-apical-patency group, canal preparation was confined to the working length and no instrument was intentionally extended beyond the apical foramen. Conventional randomization was not used. To maintain numerical balance during enrolment, a systematic consecutive allocation approach was used, whereby apical patency was performed in one case and not performed in the subsequent case. Participants were aware of the treatment approach. Postoperative pain was assessed with a 100-mm visual analog scale at 8 hours, 24 hours, 3 days, 5 days, and 7 days. Analgesic use was also recorded. Periapical lesion volume was measured in cubic millimeters using manual three-dimensional segmentation with ITK-SNAP on eligible CBCT images obtained for clinical purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apical Patency | Experimental | Procedure: Apical Patency During Root Canal TreatmentParticipants received standardized single-visit root canal treatment. During canal preparation, a #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument to maintain apical patency. No intentional apical enlargement or dentin removal was performed. |
| No Apical Patency | Active comparator | Procedure: Root Canal Treatment Without Apical PatencyParticipants received the same standardized single-visit root canal treatment, but canal preparation was confined to the working length and no instrument was intentionally extended beyond the apical foramen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients.
- Systemically healthy and not using regular systemic medications.
- A single-rooted maxillary anterior tooth requiring primary root canal treatment.
- Diagnosis of chronic apical periodontitis in the study tooth.
- The tooth was restorable.
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding.
- Previous endodontic treatment of the study tooth.
- Severe canal calcification.
- Suspected root fracture or crack.
- Internal or external 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 |
|---|---|---|
| Apical Patency During Root Canal TreatmentA #10 stainless-steel K-file was passively advanced approximately 0.5-1 mm beyond the working length after each rotary instrument during standardized single-visit root canal treatment. | Procedure or surgery | Apical Patency |
| Root Canal Treatment Without Apical PatencyStandardized single-visit root canal treatment was performed with instrumentation confined to the working length and without intentional passage of an instrument beyond the apical foramen. | Procedure or surgery | No Apical Patency |
Primary outcome
Postoperative Pain Intensity
Time frame: 8 hours, 24 hours, 3 days, 5 days, and 7 days after root canal treatment
Postoperative pain intensity was assessed using a 100-mm visual analog scale (VAS), where 0 mm indicated no pain and 100 mm indicated unbearable pain. Participants recorded the highest pain experienced during each predefined postoperative interval.
2 secondary outcomes
Number of Participants Who Used Any Postoperative Analgesic Medication
Time frame: From completion of root canal treatment through Day 7
Baseline Periapical Lesion Volume
Time frame: Baseline, before root canal treatment
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 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Pertek Hatipoğlu principal investigator
Recep Tayyip Erdogan 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 Apical Patency During Root Canal Treatment and Root Canal Treatment Without Apical Patency in people with Apical Periodontitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 8 hours, 24 hours, 3 days, 5 days, and 7 days after root canal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.