Periapical LesionNCT07867314
Effect of Apical Patency on Periapical Lesion Healing
A study testing Apical Patency During Root Canal Treatment and Root Canal Treatment Without Apical Patency in people with Periapical Lesion and Apical Periodontitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This non-randomized clinical study aims to evaluate the effect of apical patency during root canal treatment on the healing of periapical lesions in maxillary anterior teeth. Participants will be assigned to either an apical patency group or a non-patency group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Lesion, Apical Periodontitis, Dental Pulp Necroses
- 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 27 Nov 2026
- 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 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 Erdogan University Faculty of Dentistry, Department of Endodontics
Rize, Rize Province, 53020
About this study
Official title: Volumetric Evaluation of the Effect of Apical Patency on Periapical Lesion Healing: A CBCT-Based Clinical Study
This non-randomized clinical study aims to evaluate the effect of apical patency during root canal treatment on the healing of periapical lesions in maxillary anterior teeth. Participants will be assigned to either an apical patency group or a non-patency group. Changes in periapical lesion volume will be assessed using cone-beam computed tomography (CBCT) one year after treatment. The study aims to provide an objective volumetric assessment of the potential contribution of apical patency to periapical healing.
Read the detailed description
This prospective, non-randomized controlled clinical trial evaluates the volumetric effect of maintaining apical patency on the healing of periapical lesions in maxillary anterior teeth with pulpal necrosis. The study is conducted at the Recep Tayyip Erdogan University Faculty of Dentistry, Department of Endodontics.
Study Design and Standardized Interventions Participants meeting the eligibility criteria (adults aged 18-60 with a minimum 2 mm periapical lesion on maxillary single-rooted teeth) are assigned to one of two treatment arms. In the Apical Patency group, a size #10 K-file is passively advanced 0.5-1.0 mm beyond the apical foramen after each rotary instrument use to maintain canal patency without enlarging the constriction. In the Non-Patency (Standard Care) group, instrumentation is strictly confined to the established working length, and the apical foramen is not intentionally penetrated after the initial glide path preparation. To ensure consistency, all endodontic procedures are performed by a single experienced endodontist using strictly standardized chemo-mechanical protocols (2.5% NaOCl, 17% EDTA, rotary instrumentation, and standard obturation techniques).
Radiological Assessment and ALARA Compliance The healing process is monitored using a combination of two-dimensional (2D) and three-dimensional (3D) imaging. Standard 2D periapical radiographs are obtained at the 6-month post-operative follow-up to evaluate intermediate healing. For the primary 3D volumetric assessment, Cone-Beam Computed Tomography (CBCT) scans are evaluated at baseline (T0) and at a 12-month follow-up (T1). To adhere to the ALARA (As Low As Reasonably Achievable) principle, no additional CBCT scans are taken solely for research purposes; the study exclusively utilizes CBCT images acquired for routine clinical indications where 2D radiography is insufficient.
Evaluation Methodology CBCT scans are exported in DICOM format and analyzed using 3D image segmentation software (e.g., ITK-SNAP). The 3D segmentation involves defining the Region of Interest (ROI) across axial, coronal, and sagittal planes to generate a volumetric model and calculate the total lesion volume in cubic millimeters (mm³). To eliminate bias, image analysis is conducted independently by two blinded, experienced observers (an endodontist and an oral radiologist). Inter-observer reliability is statistically evaluated using the intraclass correlation coefficient (ICC), with a third expert consulted in case of discrepancies.
- Conditions
- Periapical Lesion, Apical Periodontitis, Dental Pulp Necroses, Mouth Diseases, Periapical Diseases
- Being tested
- Apical Patency During Root Canal Treatment, Root Canal Treatment Without Apical Patency
- Keywords
- Apical Patency, Root Canal Treatment, Periapical Lesion, Cone-Beam Computed Tomography
- Medical subject headings
- Periapical Periodontitis, Dental Pulp Necrosis, Mouth Diseases, Periapical Diseases
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 Group | 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 |
| Non-Patency Group | 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.
Change in 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: Before root canal treatment and at 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start22 May 2025
- Primary completion27 Nov 2026 (estimated)
- Study completion27 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionStudies 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, Gamze Özbay, Recep Tayyip Erdogan University
- Investigators
- gamze özbay, Principal investigator, Recep Tayyip Erdogan University Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867314
- Sponsor's protocol ID
- RTEU-ENDO-GO-01
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Evaluation of the Effect of Apical Patency on Periapical Lesion Healing: A CBCT-Based Clinical Study
- ClinicalTrials.gov ID
- NCT07867314
- Acronym / sponsor ID
- RTEU-ENDO-GO-01
- Conditions
- Periapical Lesion, Apical Periodontitis, Dental Pulp Necroses, Mouth Diseases, Periapical Diseases
- Keywords
- Apical Patency, Root Canal Treatment, Periapical Lesion, Cone-Beam Computed Tomography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 27 Nov 2026 (estimated)
- First posted
- 9 Oct 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 non-randomized clinical study aims to evaluate the effect of apical patency during root canal treatment on the healing of periapical lesions in maxillary anterior teeth. Participants will be assigned to either an apical patency group or a non-patency group. Changes in periapical lesion volume will be assessed using cone-beam computed tomography (CBCT) one year after treatment. The study aims to provide an objective volumetric assessment of the potential contribution of apical patency to periapical healing.
Detailed description
This prospective, non-randomized controlled clinical trial evaluates the volumetric effect of maintaining apical patency on the healing of periapical lesions in maxillary anterior teeth with pulpal necrosis. The study is conducted at the Recep Tayyip Erdogan University Faculty of Dentistry, Department of Endodontics.
Study Design and Standardized Interventions Participants meeting the eligibility criteria (adults aged 18-60 with a minimum 2 mm periapical lesion on maxillary single-rooted teeth) are assigned to one of two treatment arms. In the Apical Patency group, a size #10 K-file is passively advanced 0.5-1.0 mm beyond the apical foramen after each rotary instrument use to maintain canal patency without enlarging the constriction. In the Non-Patency (Standard Care) group, instrumentation is strictly confined to the established working length, and the apical foramen is not intentionally penetrated after the initial glide path preparation. To ensure consistency, all endodontic procedures are performed by a single experienced endodontist using strictly standardized chemo-mechanical protocols (2.5% NaOCl, 17% EDTA, rotary instrumentation, and standard obturation techniques).
Radiological Assessment and ALARA Compliance The healing process is monitored using a combination of two-dimensional (2D) and three-dimensional (3D) imaging. Standard 2D periapical radiographs are obtained at the 6-month post-operative follow-up to evaluate intermediate healing. For the primary 3D volumetric assessment, Cone-Beam Computed Tomography (CBCT) scans are evaluated at baseline (T0) and at a 12-month follow-up (T1). To adhere to the ALARA (As Low As Reasonably Achievable) principle, no additional CBCT scans are taken solely for research purposes; the study exclusively utilizes CBCT images acquired for routine clinical indications where 2D radiography is insufficient.
Evaluation Methodology CBCT scans are exported in DICOM format and analyzed using 3D image segmentation software (e.g., ITK-SNAP). The 3D segmentation involves defining the Region of Interest (ROI) across axial, coronal, and sagittal planes to generate a volumetric model and calculate the total lesion volume in cubic millimeters (mm³). To eliminate bias, image analysis is conducted independently by two blinded, experienced observers (an endodontist and an oral radiologist). Inter-observer reliability is statistically evaluated using the intraclass correlation coefficient (ICC), with a third expert consulted in case of discrepancies.
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 Group | 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. |
| Non-Patency Group | 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 Group |
| 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 | Non-Patency Group |
Primary outcome
Change in periapical lesion volume
Time frame: Before root canal treatment and at 1 year after treatment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
gamze özbay principal investigator
Recep Tayyip Erdogan University Faculty of Dentistry, Department of Endodontics
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 Periapical Lesion and 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in periapical lesion volume (time frame: Before root canal treatment and at 1 year after 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 9 Oct 2026.