Apical Extrusion During Root Canal TreatmentNCT07341451
Measuring Apical Debris Extrusion With a Novel Laboratory Technique
A study testing ProTaper Gold Rotary File System and ProTaper Next Rotary File System in people with Apical Extrusion During Root Canal Treatment, run by Fatma Selenay Ucas Yildiz at 1 site in Turkey (Türkiye).
Trial summary
Endodontic treatment occupies a critical role in dentistry, serving to prolong the longevity of teeth within the oral cavity and prevent early tooth loss. This treatment is particularly indicated in cases where the pulp tissue is infected or has suffered damage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Apical Extrusion During Root Canal Treatment
- What is being tested?
- ProTaper Gold Rotary File System and ProTaper Next Rotary File System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2025to 30 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Extracted human mandibular premolars with fully formed apices Single straight root canal confirmed radiographically No resorption, fracture, or previous endodontic treatment No caries or restorations extending into the root canal
Who cannot join
- Teeth with multiple canals, severe curvature (>20°) Immature apices or open apex External or internal root resorption Presence of root fractures, cracks, or structural anomalies Teeth with previous endodontic instrumentation or obturation Teeth with extensive coronal defects that compromise standardization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Faculty of Dentistry
Konya
About this study
Official title: Novel Experimental Methods to Measure Apically Extruded Debris and Solutions During Root Canal Intstrumantation, an Invitro Study
Endodontic treatment occupies a critical role in dentistry, serving to prolong the longevity of teeth within the oral cavity and prevent early tooth loss. This treatment is particularly indicated in cases where the pulp tissue is infected or has suffered damage. The primary objective of endodontic treatment is to clean the infected pulp tissue, shape the root canals, and adequately fill these spaces to preserve the functionality of the tooth. A successful endodontic procedure is essential not only for ensuring the longevity of the tooth but also for delaying resorption in surrounding tissues. Furthermore, it allows the patient to maintain masticatory function without losing proprioceptive sensation, which is a key indicator of the treatment's success.
During root canal instrumentation, there is a risk of necrotic debris, microorganisms, and dentin particles being displaced through the apical foramen into the periapical tissue. This displacement can increase the risk of infection and lead to postoperative complications. The preservation of the apical foramen is one of the most critical stages in the endodontic treatment process. Materials that extrude beyond the apical foramen can cause irritation and inflammation in the alveolar bone. This situation may exacerbate postoperative pain and discomfort, negatively affecting the patient's satisfaction with the treatment. Additionally, such displacements can compromise the overall success of the procedure by increasing the risk of reinfection. Therefore, preventing these displacements during root canal shaping is a factor that directly influences the success of the treatment.
Read more
In the literature, precision scales are commonly used to measure the materials displaced from the apex. However, there are discrepancies regarding the reliability of these scales, particularly concerning their measurement accuracy for very small quantities. It has been observed that these precision scales may not provide sufficient accuracy in certain situations, making it challenging to accurately determine the amount of extruded materials. This issue poses a significant barrier to the assessment of endodontic treatment outcomes. Consequently, there is a need for the development of existing measurement methods and the exploration of alternative approaches. The integration of new technologies for measuring the quantity of extruded materials could enhance the understanding and management of treatment processes.
In this context, the primary aim of this research is to develop new methods for the more accurate and reliable measurement of materials displaced from the apex. Novel measurement techniques will allow for a more precise determination of the quantity of extruded materials, thereby enhancing the efficacy of endodontic treatment processes. Furthermore, this research aims to contribute to the reduction of postoperative complications and improve patient satisfaction during the treatment process. Ultimately, innovative approaches of this nature are of great importance for the success of endodontic treatments and patient satisfaction. Research in the field of endodontics will not only guide clinical practices but also make significant contributions to the scientific literature. Such innovations will assist in the development of future treatment protocols and the enhancement of patient care.
Read the detailed description
Detailed Description
The purpose of this study is to develop alternative and reliable measurement methods for quantifying solid and liquid substances unintentionally extruded from the apical foramen during endodontic treatment with higher precision. The investigators will assess the limitations and applicability of the proposed methods, which are expected to contribute to future treatment improvements. The study also aims to evaluate the potential of these methods to reduce postoperative pain and infection risks in clinical practice. This research is anticipated to make significant contributions to enhancing the effectiveness and reliability of endodontic treatment processes.
This in vitro study was designed to evaluate the amount of apical extrusion (debris and irrigation solution overflow) occurring during root canal treatment. A total of 80 extracted human lower premolar teeth, selected according to predefined criteria, were used. The primary objective was to compare the effects of two different rotary file systems-ProTaper Gold and ProTaper Next-on the amount of apical overflow.
Selection and Preparation of Specimens
The specimens consisted of extracted lower premolars with fully developed roots, a single canal, a single apical foramen, moderate root inclination, and no previous endodontic treatment. Root canal inclination angles were determined using the Schneider method, and only specimens with inclinations between 5° and 20° were included to better simulate clinical conditions. Teeth with multiple apical foramina, cracks, or fractures were excluded following examination under magnification. The criteria of single root and single canal were verified radiographically.
Disinfection and Preparation
Teeth were disinfected in 5% sodium hypochlorite for 10 minutes, rinsed with distilled water, and stored in physiological saline. Standard endodontic access cavities were prepared, and canal orifices were identified using an endodontic explorer. Pulp remnants were removed with hand files. The working length was standardized to 0.5 mm short of the anatomical apex for all specimens.
Root Canal Preparation and Standardization
Initial shaping was performed with a ProTaper Gold S1 file using the manufacturer's recommended speed and torque settings. Irrigation with 2 ml sodium hypochlorite was applied during instrumentation. Specimens in which a #20 K-file could pass through the apical foramen were excluded to maintain standardization.
Chromium-cobalt particles were compacted into the canals to assess the apical extrusion of debris radiographically. The particles were inserted using an excavator and pluggers, ensuring homogeneous distribution. After radiographic confirmation, each specimen was placed into the experimental setup.
Experimental Setup
Each tooth was mounted on an acrylic block with its apical region in contact with a moisture-absorbing sponge that simulated periodontal tissues. This setup provided a radiolucent background for the radiographic detection of extruded materials and allowed fluid absorption, enabling blinded assessment.
Groups and Experimental Procedure
Eighty specimens were randomly assigned into four groups (n = 20) as follows:
Group 1: Debris overflow - ProTaper Gold
Group 2: Debris overflow - ProTaper Next
Group 3: Solution overflow - ProTaper Gold
Group 4: Solution overflow - ProTaper Next
Access cavities and pulp chambers were left unsealed to reflect clinical conditions.
Debris Overflow Groups (Groups 1 and 2) Root canals were instrumented to working length using ProTaper Gold or ProTaper Next files. Irrigation with 2 ml NaOCl was performed at each file stage, followed by a final rinse with 6 ml NaOCl for 3 minutes. Extruded particles were visualized radiographically and quantified using ImageJ software.
Solution Overflow Groups (Groups 3 and 4) To opacify irrigation solutions, barium sulfate powder was added to NaOCl and EDTA. The canals were instrumented with ProTaper Gold or ProTaper Next systems using these opacified irrigants. The amount of extruded solution was recorded radiographically and analyzed in ImageJ.
Data Collection and Analysis
Digital radiographs of all samples were obtained at a standardized 15 cm distance. The radiographs were evaluated blindly, and the surface area and density of extruded opaque materials were measured as percentages. Data were recorded in Excel spreadsheets and prepared for statistical analysis.
Contribution of the Study
This study introduces a novel radiographic approach for assessing apical extrusion. The use of chromium-cobalt particles and barium sulfate-enhanced irrigants enables objective visualization of extruded material, while the moisture-absorbing sponge system effectively simulates periodontal conditions. The findings are expected to facilitate the comparison of rotary file systems in terms of apical extrusion and to support the development of more reliable and clinically applicable endodontic procedures.
- Being tested
- ProTaper Gold Rotary File System, ProTaper Next Rotary File System
- Keywords
- Debris extrusion, Irrigant extrusion, ProTaper Next, ProTaper Gold, Apical extrusion, Chromium-cobalt particles, Metal particles, Barium sulfate, Radiopacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTaper Gold Rotary File SystemDevice
Root canal instrumentation performed using ProTaper Gold rotary file system at working length. Files were used in sequence (S1, F1-F3) following the manufacturer's instructions for torque and rpm. Irrigation was performed with NaOCl during shaping
ProTaper Next Rotary File SystemDevice
Root canal instrumentation performed using ProTaper Next rotary file system at working length. Files were used in sequence (X1-X3) following the manufacturer's instructions for torque and rpm. Irrigation was performed with NaOCl during shaping
| Study group | Role | What they receive |
|---|---|---|
| ProTaper Gold - Debris Extrusion | Experimental | Extracted mandibular premolars shaped with ProTaper Gold rotary files.
Apical extrusion of debris measured using chromium-cobalt particles. Receives: Device: ProTaper Gold Rotary File System |
| ProTaper Next - Debris Extrusion | Experimental | Extracted mandibular premolars shaped with ProTaper Next rotary files.
Apical extrusion of debris measured using chromium-cobalt particles. Receives: Device: ProTaper Next Rotary File System |
| ProTaper Gold - Irrigant Extrusion | Experimental | Extracted mandibular premolars shaped with ProTaper Gold rotary files.
Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl. Receives: Device: ProTaper Gold Rotary File System |
| ProTaper Next - Irrigant Extrusion | Experimental | Extracted mandibular premolars shaped with ProTaper Next rotary files.
Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl Receives: Device: ProTaper Next Rotary File System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Area of Apically Extruded Debris
During the single experimental session of root canal instrumentation and irrigation
Measured: Baseline
Radiographic Area of Apically Extruded Irrigant
Quantification of apically extruded irrigant using barium sulfate-enhanced NaOCl/EDTA solutions. After instrumentation, standardized digital radiographs are analyzed in ImageJ to measure the radiopaque area and spread pattern of the extruded irrigant on the sponge background.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start29 Sep 2025
- Primary completion30 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical Extrusion During Root Canal TreatmentStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eighty extracted human mandibular premolars were randomly assigned into four parallel groups (n=20 each) to evaluate apical extrusion of debris and irrigants using two different rotary systems (ProTaper Gold, ProTaper Next) and two evaluation methods (metal particles for debris, barium sulfate solution for irrigants)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma Selenay Ucas Yildiz
- Sponsor type
- University, hospital or other
- Collaborators
- Necmettin Erbakan University
- Responsible party
- Sponsor-investigator, Fatma Selenay Ucas Yildiz, Necmettin Erbakan University
- Investigators
- Arslan Terlemez, DDS, PhD, Study director, Necmettin Erbakan University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341451
- Sponsor's protocol ID
- 2025/539
- Other IDs
- 23068
- Status last verified
- Jan 2026
- First submitted
- 1 Oct 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not involve human participants or individual participant data. All experiments were performed on extracted teeth in a laboratory setting. Therefore, no IPD will be generated or shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Experimental Methods to Measure Apically Extruded Debris and Solutions During Root Canal Intstrumantation, an Invitro Study
- ClinicalTrials.gov ID
- NCT07341451
- Acronym / sponsor ID
- 2025/539
- Keywords
- Debris extrusion, Irrigant extrusion, ProTaper Next, ProTaper Gold, Apical extrusion, Chromium-cobalt particles, Metal particles, Barium sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fatma Selenay Ucas YildizUniversity, hospital or other
- Collaborators
- Necmettin Erbakan University
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 14 Jan 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.
Endodontic treatment occupies a critical role in dentistry, serving to prolong the longevity of teeth within the oral cavity and prevent early tooth loss. This treatment is particularly indicated in cases where the pulp tissue is infected or has suffered damage. The primary objective of endodontic treatment is to clean the infected pulp tissue, shape the root canals, and adequately fill these spaces to preserve the functionality of the tooth. A successful endodontic procedure is essential not only for ensuring the longevity of the tooth but also for delaying resorption in surrounding tissues. Furthermore, it allows the patient to maintain masticatory function without losing proprioceptive sensation, which is a key indicator of the treatment's success.
During root canal instrumentation, there is a risk of necrotic debris, microorganisms, and dentin particles being displaced through the apical foramen into the periapical tissue. This displacement can increase the risk of infection and lead to postoperative complications. The preservation of the apical foramen is one of the most critical stages in the endodontic treatment process. Materials that extrude beyond the apical foramen can cause irritation and inflammation in the alveolar bone. This situation may exacerbate postoperative pain and discomfort, negatively affecting the patient's satisfaction with the treatment. Additionally, such displacements can compromise the overall success of the procedure by increasing the risk of reinfection. Therefore, preventing these displacements during root canal shaping is a factor that directly influences the success of the treatment.
In the literature, precision scales are commonly used to measure the materials displaced from the apex. However, there are discrepancies regarding the reliability of these scales, particularly concerning their measurement accuracy for very small quantities. It has been observed that these precision scales may not provide sufficient accuracy in certain situations, making it challenging to accurately determine the amount of extruded materials. This issue poses a significant barrier to the assessment of endodontic treatment outcomes. Consequently, there is a need for the development of existing measurement methods and the exploration of alternative approaches. The integration of new technologies for measuring the quantity of extruded materials could enhance the understanding and management of treatment processes.
In this context, the primary aim of this research is to develop new methods for the more accurate and reliable measurement of materials displaced from the apex. Novel measurement techniques will allow for a more precise determination of the quantity of extruded materials, thereby enhancing the efficacy of endodontic treatment processes. Furthermore, this research aims to contribute to the reduction of postoperative complications and improve patient satisfaction during the treatment process. Ultimately, innovative approaches of this nature are of great importance for the success of endodontic treatments and patient satisfaction. Research in the field of endodontics will not only guide clinical practices but also make significant contributions to the scientific literature. Such innovations will assist in the development of future treatment protocols and the enhancement of patient care.
Detailed description
Detailed Description
The purpose of this study is to develop alternative and reliable measurement methods for quantifying solid and liquid substances unintentionally extruded from the apical foramen during endodontic treatment with higher precision. The investigators will assess the limitations and applicability of the proposed methods, which are expected to contribute to future treatment improvements. The study also aims to evaluate the potential of these methods to reduce postoperative pain and infection risks in clinical practice. This research is anticipated to make significant contributions to enhancing the effectiveness and reliability of endodontic treatment processes.
This in vitro study was designed to evaluate the amount of apical extrusion (debris and irrigation solution overflow) occurring during root canal treatment. A total of 80 extracted human lower premolar teeth, selected according to predefined criteria, were used. The primary objective was to compare the effects of two different rotary file systems-ProTaper Gold and ProTaper Next-on the amount of apical overflow.
Selection and Preparation of Specimens
The specimens consisted of extracted lower premolars with fully developed roots, a single canal, a single apical foramen, moderate root inclination, and no previous endodontic treatment. Root canal inclination angles were determined using the Schneider method, and only specimens with inclinations between 5° and 20° were included to better simulate clinical conditions. Teeth with multiple apical foramina, cracks, or fractures were excluded following examination under magnification. The criteria of single root and single canal were verified radiographically.
Disinfection and Preparation
Teeth were disinfected in 5% sodium hypochlorite for 10 minutes, rinsed with distilled water, and stored in physiological saline. Standard endodontic access cavities were prepared, and canal orifices were identified using an endodontic explorer. Pulp remnants were removed with hand files. The working length was standardized to 0.5 mm short of the anatomical apex for all specimens.
Root Canal Preparation and Standardization
Initial shaping was performed with a ProTaper Gold S1 file using the manufacturer's recommended speed and torque settings. Irrigation with 2 ml sodium hypochlorite was applied during instrumentation. Specimens in which a #20 K-file could pass through the apical foramen were excluded to maintain standardization.
Chromium-cobalt particles were compacted into the canals to assess the apical extrusion of debris radiographically. The particles were inserted using an excavator and pluggers, ensuring homogeneous distribution. After radiographic confirmation, each specimen was placed into the experimental setup.
Experimental Setup
Each tooth was mounted on an acrylic block with its apical region in contact with a moisture-absorbing sponge that simulated periodontal tissues. This setup provided a radiolucent background for the radiographic detection of extruded materials and allowed fluid absorption, enabling blinded assessment.
Groups and Experimental Procedure
Eighty specimens were randomly assigned into four groups (n = 20) as follows:
Group 1: Debris overflow - ProTaper Gold
Group 2: Debris overflow - ProTaper Next
Group 3: Solution overflow - ProTaper Gold
Group 4: Solution overflow - ProTaper Next
Access cavities and pulp chambers were left unsealed to reflect clinical conditions.
Debris Overflow Groups (Groups 1 and 2) Root canals were instrumented to working length using ProTaper Gold or ProTaper Next files. Irrigation with 2 ml NaOCl was performed at each file stage, followed by a final rinse with 6 ml NaOCl for 3 minutes. Extruded particles were visualized radiographically and quantified using ImageJ software.
Solution Overflow Groups (Groups 3 and 4) To opacify irrigation solutions, barium sulfate powder was added to NaOCl and EDTA. The canals were instrumented with ProTaper Gold or ProTaper Next systems using these opacified irrigants. The amount of extruded solution was recorded radiographically and analyzed in ImageJ.
Data Collection and Analysis
Digital radiographs of all samples were obtained at a standardized 15 cm distance. The radiographs were evaluated blindly, and the surface area and density of extruded opaque materials were measured as percentages. Data were recorded in Excel spreadsheets and prepared for statistical analysis.
Contribution of the Study
This study introduces a novel radiographic approach for assessing apical extrusion. The use of chromium-cobalt particles and barium sulfate-enhanced irrigants enables objective visualization of extruded material, while the moisture-absorbing sponge system effectively simulates periodontal conditions. The findings are expected to facilitate the comparison of rotary file systems in terms of apical extrusion and to support the development of more reliable and clinically applicable endodontic procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Eighty extracted human mandibular premolars were randomly assigned into four parallel groups (n=20 each) to evaluate apical extrusion of debris and irrigants using two different rotary systems (ProTaper Gold, ProTaper Next) and two evaluation methods (metal particles for debris, barium sulfate solution for irrigants)
| Arm | Type | Receives |
|---|---|---|
| ProTaper Gold - Debris Extrusion | Experimental | Device: ProTaper Gold Rotary File SystemExtracted mandibular premolars shaped with ProTaper Gold rotary files. Apical extrusion of debris measured using chromium-cobalt particles. |
| ProTaper Next - Debris Extrusion | Experimental | Device: ProTaper Next Rotary File SystemExtracted mandibular premolars shaped with ProTaper Next rotary files. Apical extrusion of debris measured using chromium-cobalt particles. |
| ProTaper Gold - Irrigant Extrusion | Experimental | Device: ProTaper Gold Rotary File SystemExtracted mandibular premolars shaped with ProTaper Gold rotary files. Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl. |
| ProTaper Next - Irrigant Extrusion | Experimental | Device: ProTaper Next Rotary File SystemExtracted mandibular premolars shaped with ProTaper Next rotary files. Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Extracted human mandibular premolars with fully formed apices Single straight root canal confirmed radiographically No resorption, fracture, or previous endodontic treatment No caries or restorations extending into the root canal
Key exclusion criteria (1 listed)
- Teeth with multiple canals, severe curvature (>20°) Immature apices or open apex External or internal root resorption Presence of root fractures, cracks, or structural anomalies Teeth with previous endodontic instrumentation or obturation Teeth with extensive coronal defects that compromise standardization
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 |
|---|---|---|
| ProTaper Gold Rotary File SystemRoot canal instrumentation performed using ProTaper Gold rotary file system at working length. Files were used in sequence (S1, F1-F3) following the manufacturer's instructions for torque and rpm. Irrigation was performed with NaOCl during shaping | Device | ProTaper Gold - Debris Extrusion, ProTaper Gold - Irrigant Extrusion |
| ProTaper Next Rotary File SystemRoot canal instrumentation performed using ProTaper Next rotary file system at working length. Files were used in sequence (X1-X3) following the manufacturer's instructions for torque and rpm. Irrigation was performed with NaOCl during shaping | Device | ProTaper Next - Debris Extrusion, ProTaper Next - Irrigant Extrusion |
Primary outcome
Radiographic Area of Apically Extruded Debris
Time frame: Baseline
During the single experimental session of root canal instrumentation and irrigation
Radiographic Area of Apically Extruded Irrigant
Time frame: Baseline
Quantification of apically extruded irrigant using barium sulfate-enhanced NaOCl/EDTA solutions. After instrumentation, standardized digital radiographs are analyzed in ImageJ to measure the radiopaque area and spread pattern of the extruded irrigant on the sponge background.
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 14 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. This study does not involve human participants or individual participant data. All experiments were performed on extracted teeth in a laboratory setting. Therefore, no IPD will be generated or shared.
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.
Arslan Terlemez, DDS, PhD study director
Necmettin Erbakan 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 ProTaper Gold Rotary File System and ProTaper Next Rotary File System in people with Apical Extrusion During Root Canal Treatment, run by Fatma Selenay Ucas Yildiz 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 1 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 14 Jan 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?
Radiographic Area of Apically Extruded Debris (time frame: Baseline). The study lists 2 primary outcomes in all. 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 14 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.