Periapical HealingNCT07583004
Effect of Different Root Canal Preparation Sizes and Remaining Tooth Structure on the Survival of Endodontically Treated Mandibular Molars
A study testing ProTaper Gold and TruNatomy file system in people with Periapical Healing and Restoration Survival, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Teeth that have undergone endodontic treatment are biomechanically weakened compared to vital teeth due to factors such as extensive carious lesions, previous restorations, loss of marginal ridges and pericervical dentin, and hard tissue removal during access cavity preparation and root canal instrumentation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Healing, Restoration Survival
- What is being tested?
- ProTaper Gold and TruNatomy file system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Aug 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Patients with mandibular molar teeth diagnosed with symptomatic irreversible pulpitis according to the pulp disease classification recommended by the American Association of Endodontists
Patients with active caries in the relevant tooth that would create O, MO/OD, or MOD type cavitations.
Patients with periodontally healthy teeth (Grade I mobility or <4 mm pocket depth).
Patients with no systemic diseases (ASA I or II).
Patients between the ages of 18-60.
Teeth where rubber dam isolation could be achieved.
Cases where the remaining sound tooth structure allowed for a direct composite restoration.
Exclusion Criteria:Teeth with non-vital pulp and/or observable periapical lesions.
Teeth that were not periodontally healthy (Grade II/III mobility or >3 mm pocket depth).
Teeth with complex root canal anatomy (curved canals, C-shaped canals, calcified/obstructed canals, etc.).
Patients with systemic diseases, or those who were pregnant or breastfeeding.
Patients with parafunctional habits such as bruxism.
Teeth without an opposing tooth in the maxillary arch.
Teeth that could not be restored due to advanced crown destruction or those with existing prosthetic restorations.
Patients whose endodontic treatment had already been initiated elsewhere.
Patients who experienced complications during the treatment procedure.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Different Root Canal Preparation Sizes and Remaining Tooth Structure on the Survival of Endodontically Treated Mandibular Molars: A Randomized Clinical Trial
Teeth that have undergone endodontic treatment are biomechanically weakened compared to vital teeth due to factors such as extensive carious lesions, previous restorations, loss of marginal ridges and pericervical dentin, and hard tissue removal during access cavity preparation and root canal instrumentation. Additionally, the quantity and quality of the remaining coronal tooth structure, the presence of marginal ridges, the ferrule effect, and the integrity of pericervical dentin directly influence both fracture resistance and the long-term success of restorations.
Following endodontic access cavity preparation, the fracture resistance of the tooth decreases by approximately 5%. This reduction increases to around 20-30% in the case of unilateral marginal ridge loss (mesio-occlusal [MO] or disto-occlusal [DO] cavities), and can reach up to 63% when both marginal ridges are lost (mesio-occluso-distal [MOD] cavities). This condition may lead to cusp deflection under occlusal forces and, particularly in the absence of appropriate post-endodontic restoration, may result in failures such as vertical root fractures.
Read more
It has been reported that, after caries removal and access cavity preparation, the amount of remaining sound coronal tooth structure may play an important role in determining the extent of mechanical preparation during treatment. The goal of mechanical preparation of the root canal system is to remove infected dentin and biofilm as much as possible and to create a continuously tapered canal shape that allows effective delivery of irrigants to the apical region. Although conventional preparation principles may provide higher levels of disinfection, they have been associated with reduced tooth strength, particularly due to the loss of resistance in the pericervical area. This has led to the development of more conservative root canal preparation strategies using instruments with smaller apical sizes and tapers.
Previous studies investigating the relationship between preparation size and fracture resistance have shown considerable heterogeneity. Moreover, the predominantly in vitro nature of these studies limits their ability to accurately simulate clinical conditions. In addition, factors such as the amount of remaining tooth structure after treatment and the effectiveness of the final restoration are often overlooked. Therefore, it is important to support in vitro findings with clinical studies. To date, there is no long-term clinical study in the literature evaluating the combined effects of conventional and conservative preparation strategies on clinical survival and periodontal health in teeth with varying degrees of coronal tissue loss.
The aim of this study is to clinically and radiographically evaluate the survival of mandibular molars with different amounts of remaining tooth structure (O, MO/DO, and MOD) following conventional and conservative root canal preparation. The null hypothesis is that different preparation strategies and the amount of remaining tooth structure have a similar effect on tooth survival.
Read the detailed description
The sample size calculation was performed using G*Power 3.1.9.2 software, based on a significance level of 5% (α = 0.05), an effect size of 0.4921, and a statistical power of 95% (1-β = 0.80). The analysis indicated that a minimum of 10 students per group would be required to detect a statistically significant effect.
3.2. Clinical Methodology Within the scope of this study, patients who applied to the University of Health Sciences, Gülhane Faculty of Dentistry, Department of Endodontics with complaints of pain in the mandibular first and second molar teeth will be evaluated based on the following inclusion and exclusion criteria.
3.2.1. Clinical Examination Clinical examinations will be performed to diagnose irreversible pulpitis. Data regarding pain onset, duration, spontaneity, nocturnal increases, and sensitivity to thermal stimuli (hot/cold) will be recorded. Pain will be evaluated using the Visual Analog Scale (VAS); only patients with moderate-to-severe (symptomatic) pain will be included.
Tooth vitality will be assessed via Electric Pulp Test (EPT) and cold tests. To ensure reliability, tests will be also applied to the contralateral tooth in the opposite arch. Teeth responding positively will be included. However, as partial necrosis can occur in multi-rooted teeth, patients will be excluded if no pulpal bleeding will be observed following access cavity preparation. Percussion and palpation sensitivity will be also evaluated.
3.2.2. Radiographic Examination Radiographic examinations will be conducted using the parallel technique with a periapical radiograph. In this technique, the image receptor is positioned parallel to the long axis of the tooth, and the X-ray beam is directed perpendicularly. This minimizes magnification and distortion, providing the most accurate anatomical view and allowing for standardized comparisons of pre- and post-treatment records.
Patients with a Periapical Index (PAI) score of <3 will be included. All images will be saved within the university's imaging system.
3.2.3. Endodontic Treatment Protocol Patients will be inferior alveolar nerve block anesthesia using 80mg/2mL+0.02mg/2mL articaine hydrochloride (Maxicaine Forte). Success will bedefined as significant lip numbness within 15 minutes. Following rubber dam isolation, tooth surfaces will be disinfected with 30% H2O2 for 30 seconds, followed by 2.5% NaOCl, which will be then inactivated with 5% sodium thiosulfate.
Caries will be removed using high-speed diamond round burs and low-speed tungsten carbide burs. Access cavities will be prepared using sterile diamond fissure burs and safe-ended burs (Endo-Z).
Teeth will be assigned to groups based on the remaining dentin walls:
Group 1: Occlusal cavity (4 walls)
Group 2: MO/OD cavity (3 walls)
Group 3: MOD cavity (2 walls)
Cusp thickness will be measured with a periodontal probe; only cases with a wall thickness of ≥1.5-2 mm were included for biomechanical safety. Patients in each group will be then randomized into two subgroups based on the file system: ProTaper Gold or TruNatomy.
Working length (WL) will be determined using a #10 K-file and an apex locator (set 1 mm short of the "0.0" point) and will be onfirmed radiographically.
ProTaper Gold Group: Shaped using Sx-S1-S2-F1-F2-F3 files in rotation. Mesial canals will be enlarged to F2, distal to F3.
TruNatomy Group: Shaped using Orifice Shaper, Glider, Small, Prime, and Medium files in rotation.
Irrigation will be performed between file changes using 2.5% NaOCl (15 mL total) via a side-vented needle (Irriflex). Final irrigation consisted of 3 mL each of: 2.5% NaOCl → Distilled water → 17% EDTA → Distilled water → 2.5% NaOCl. The final NaOCl and EDTA will be activated using the EndoActivator (3 cycles of 30 seconds).
Canals will be dried with paper points and filled with Dia-Proseal resin sealer and gutta-percha using the lateral condensation technique. Proper fit will be ensured using ProTaper Gold or TruNatomy Conform Gutta Percha. Post-obturation radiographs will be taken using the parallel technique.
Restoration and Follow-up The final restoration will be completed using GC G-ænial Posterior composite resin.
- Conditions
- Periapical Healing, Restoration Survival
- Being tested
- ProTaper Gold, TruNatomy file system
- Keywords
- endodontics, restoration, preparation size, tooth survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTaper GoldProcedure or surgery
Also called File system
Patients will be treated endodontically using Protaper Gold rotary file system
TruNatomy file systemProcedure or surgery
TruNatomy file system
| Study group | Role | What they receive |
|---|---|---|
| ProTaper Gold | Experimental | Mandibular molar teeth of patients will be treated using ProTaper Gold rotary file sytem. Receives: Procedure: ProTaper Gold |
| TruNatomy | Experimental | Mandibular molar teeth of patients will be treated using TruNatomy rotary file sytem. Receives: Procedure: TruNatomy file system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical healing
Evaluation of the periapical healing based on the PAI score system. The system provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features.
Measured: at 6, 12 and 18 months
Secondary outcomes (1)
Restoration survival
Restoration quality was assessed using USPHS criteria. This criteria includes parameters as marginal adaptation, anatomic form, secondary caries, retantion, hypersensitivity, and color match.
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jan 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periapical HealingStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patiens with different intact dentin walls will be divided into 2 groups based on the used file systems with different sizes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Nur Usta, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583004
- Sponsor's protocol ID
- SBU-GFOD-ENDO-SILANURUSTA-003
- Other IDs
- 2024/075
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Within the scope of the necessity of protecting the individual information of the students and patients, it is considered that the recorded data will not be shared.
Publications
Usta SN, Silva EJNL, Falakaloglu S, Gundogar M. Does minimally invasive canal preparation provide higher fracture resistance of endodontically treated teeth? A systematic review of in vitro studies. Restor Dent Endod. 2023 Oct 17;48(4):e34. doi: 10.5395/rde.2023.48.e34. eCollection 2023 Nov.
PubMed 38053776Usta SN, Tekkanat H, Saglam Y, Aydin C. Exploring the impact of remaining tooth structure and preparation size on the fracture resistance of endodontically treated mandibular premolars. J Dent Res Dent Clin Dent Prospects. 2025 Mar 31;19(1):23-28. doi: 10.34172/joddd.025.42125. eCollection 2025 Mar.
PubMed 40464029Fransson H, Dawson V. Tooth survival after endodontic treatment. Int Endod J. 2023 Mar;56 Suppl 2:140-153. doi: 10.1111/iej.13835. Epub 2022 Oct 2.
PubMed 36149887
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Different Root Canal Preparation Sizes and Remaining Tooth Structure on the Survival of Endodontically Treated Mandibular Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07583004
- Acronym / sponsor ID
- SBU-GFOD-ENDO-SILANURUSTA-003
- Conditions
- Periapical Healing, Restoration Survival
- Keywords
- endodontics, restoration, preparation size, tooth survival
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 May 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.
Teeth that have undergone endodontic treatment are biomechanically weakened compared to vital teeth due to factors such as extensive carious lesions, previous restorations, loss of marginal ridges and pericervical dentin, and hard tissue removal during access cavity preparation and root canal instrumentation. Additionally, the quantity and quality of the remaining coronal tooth structure, the presence of marginal ridges, the ferrule effect, and the integrity of pericervical dentin directly influence both fracture resistance and the long-term success of restorations.
Following endodontic access cavity preparation, the fracture resistance of the tooth decreases by approximately 5%. This reduction increases to around 20-30% in the case of unilateral marginal ridge loss (mesio-occlusal [MO] or disto-occlusal [DO] cavities), and can reach up to 63% when both marginal ridges are lost (mesio-occluso-distal [MOD] cavities). This condition may lead to cusp deflection under occlusal forces and, particularly in the absence of appropriate post-endodontic restoration, may result in failures such as vertical root fractures.
It has been reported that, after caries removal and access cavity preparation, the amount of remaining sound coronal tooth structure may play an important role in determining the extent of mechanical preparation during treatment. The goal of mechanical preparation of the root canal system is to remove infected dentin and biofilm as much as possible and to create a continuously tapered canal shape that allows effective delivery of irrigants to the apical region. Although conventional preparation principles may provide higher levels of disinfection, they have been associated with reduced tooth strength, particularly due to the loss of resistance in the pericervical area. This has led to the development of more conservative root canal preparation strategies using instruments with smaller apical sizes and tapers.
Previous studies investigating the relationship between preparation size and fracture resistance have shown considerable heterogeneity. Moreover, the predominantly in vitro nature of these studies limits their ability to accurately simulate clinical conditions. In addition, factors such as the amount of remaining tooth structure after treatment and the effectiveness of the final restoration are often overlooked. Therefore, it is important to support in vitro findings with clinical studies. To date, there is no long-term clinical study in the literature evaluating the combined effects of conventional and conservative preparation strategies on clinical survival and periodontal health in teeth with varying degrees of coronal tissue loss.
The aim of this study is to clinically and radiographically evaluate the survival of mandibular molars with different amounts of remaining tooth structure (O, MO/DO, and MOD) following conventional and conservative root canal preparation. The null hypothesis is that different preparation strategies and the amount of remaining tooth structure have a similar effect on tooth survival.
Detailed description
The sample size calculation was performed using G*Power 3.1.9.2 software, based on a significance level of 5% (α = 0.05), an effect size of 0.4921, and a statistical power of 95% (1-β = 0.80). The analysis indicated that a minimum of 10 students per group would be required to detect a statistically significant effect.
3.2. Clinical Methodology Within the scope of this study, patients who applied to the University of Health Sciences, Gülhane Faculty of Dentistry, Department of Endodontics with complaints of pain in the mandibular first and second molar teeth will be evaluated based on the following inclusion and exclusion criteria.
3.2.1. Clinical Examination Clinical examinations will be performed to diagnose irreversible pulpitis. Data regarding pain onset, duration, spontaneity, nocturnal increases, and sensitivity to thermal stimuli (hot/cold) will be recorded. Pain will be evaluated using the Visual Analog Scale (VAS); only patients with moderate-to-severe (symptomatic) pain will be included.
Tooth vitality will be assessed via Electric Pulp Test (EPT) and cold tests. To ensure reliability, tests will be also applied to the contralateral tooth in the opposite arch. Teeth responding positively will be included. However, as partial necrosis can occur in multi-rooted teeth, patients will be excluded if no pulpal bleeding will be observed following access cavity preparation. Percussion and palpation sensitivity will be also evaluated.
3.2.2. Radiographic Examination Radiographic examinations will be conducted using the parallel technique with a periapical radiograph. In this technique, the image receptor is positioned parallel to the long axis of the tooth, and the X-ray beam is directed perpendicularly. This minimizes magnification and distortion, providing the most accurate anatomical view and allowing for standardized comparisons of pre- and post-treatment records.
Patients with a Periapical Index (PAI) score of <3 will be included. All images will be saved within the university's imaging system.
3.2.3. Endodontic Treatment Protocol Patients will be inferior alveolar nerve block anesthesia using 80mg/2mL+0.02mg/2mL articaine hydrochloride (Maxicaine Forte). Success will bedefined as significant lip numbness within 15 minutes. Following rubber dam isolation, tooth surfaces will be disinfected with 30% H2O2 for 30 seconds, followed by 2.5% NaOCl, which will be then inactivated with 5% sodium thiosulfate.
Caries will be removed using high-speed diamond round burs and low-speed tungsten carbide burs. Access cavities will be prepared using sterile diamond fissure burs and safe-ended burs (Endo-Z).
Teeth will be assigned to groups based on the remaining dentin walls:
Group 1: Occlusal cavity (4 walls)
Group 2: MO/OD cavity (3 walls)
Group 3: MOD cavity (2 walls)
Cusp thickness will be measured with a periodontal probe; only cases with a wall thickness of ≥1.5-2 mm were included for biomechanical safety. Patients in each group will be then randomized into two subgroups based on the file system: ProTaper Gold or TruNatomy.
Working length (WL) will be determined using a #10 K-file and an apex locator (set 1 mm short of the "0.0" point) and will be onfirmed radiographically.
ProTaper Gold Group: Shaped using Sx-S1-S2-F1-F2-F3 files in rotation. Mesial canals will be enlarged to F2, distal to F3.
TruNatomy Group: Shaped using Orifice Shaper, Glider, Small, Prime, and Medium files in rotation.
Irrigation will be performed between file changes using 2.5% NaOCl (15 mL total) via a side-vented needle (Irriflex). Final irrigation consisted of 3 mL each of: 2.5% NaOCl → Distilled water → 17% EDTA → Distilled water → 2.5% NaOCl. The final NaOCl and EDTA will be activated using the EndoActivator (3 cycles of 30 seconds).
Canals will be dried with paper points and filled with Dia-Proseal resin sealer and gutta-percha using the lateral condensation technique. Proper fit will be ensured using ProTaper Gold or TruNatomy Conform Gutta Percha. Post-obturation radiographs will be taken using the parallel technique.
Restoration and Follow-up The final restoration will be completed using GC G-ænial Posterior composite resin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patiens with different intact dentin walls will be divided into 2 groups based on the used file systems with different sizes.
| Arm | Type | Receives |
|---|---|---|
| ProTaper Gold | Experimental | Procedure: ProTaper GoldMandibular molar teeth of patients will be treated using ProTaper Gold rotary file sytem. |
| TruNatomy | Experimental | Procedure: TruNatomy file systemMandibular molar teeth of patients will be treated using TruNatomy rotary file sytem. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 GoldAlso: File systemPatients will be treated endodontically using Protaper Gold rotary file system | Procedure or surgery | ProTaper Gold |
| TruNatomy file systemTruNatomy file system | Procedure or surgery | TruNatomy |
Primary outcome
Periapical healing
Time frame: at 6, 12 and 18 months
Evaluation of the periapical healing based on the PAI score system. The system provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features.
1 secondary outcome
Restoration survival
Time frame: 6, 12 and 18 months
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 13 May 2026.
- Results publication: PubMed 38053776Usta SN, Silva EJNL, Falakaloglu S, Gundogar M. Does minimally invasive canal preparation provide higher fracture resistance of endodontically treated teeth? A systematic review of in vitro studies. Restor Dent Endod. 2023 Oct 17;48(4):e34. doi: 10.5395/rde.2023.48.e34. eCollection 2023 Nov.
- Results publication: PubMed 40464029Usta SN, Tekkanat H, Saglam Y, Aydin C. Exploring the impact of remaining tooth structure and preparation size on the fracture resistance of endodontically treated mandibular premolars. J Dent Res Dent Clin Dent Prospects. 2025 Mar 31;19(1):23-28. doi: 10.34172/joddd.025.42125. eCollection 2025 Mar.
- Results publication: PubMed 36149887Fransson H, Dawson V. Tooth survival after endodontic treatment. Int Endod J. 2023 Mar;56 Suppl 2:140-153. doi: 10.1111/iej.13835. Epub 2022 Oct 2.
- Individual participant dataSharing planned: No. Within the scope of the necessity of protecting the individual information of the students and patients, it is considered that the recorded data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and TruNatomy file system in people with Periapical Healing and Restoration Survival, run by Saglik Bilimleri Universitesi 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?
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 13 May 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?
Periapical healing (time frame: at 6, 12 and 18 months). 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 NCT07583004, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 5 Nov 2026.