Temporomandibular Joint Disc DisplacementNCT07345104
Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement
A study testing Clinical Clicking Elimination Repositioning Splint, Adjustable Articulator Repositioning Splint and CAD-Designed Anatomical Repositioning Splint in people with Temporomandibular Joint Disc Displacement, run by Fujian Medical University at 1 site in China.
Trial summary
This study evaluates a new, individualized treatment for adolescents with temporomandibular joint disorders (TMD) caused by bilateral, reducible disc displacement. Participants will undergo clinical and imaging examinations, including cone-beam CT (CBCT), MRI, and intraoral digital scanning to create three-dimensional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Joint Disc Displacement
- What is being tested?
- Clinical Clicking Elimination Repositioning Splint, Adjustable Articulator Repositioning Splint and CAD-Designed Anatomical Repositioning Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 20 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of reducible temporomandibular joint (TMJ) disc displacement according to the 2014 revised criteria of the International Association for Dental Research;
- Bilateral reducible disc displacement confirmed by MRI;
- Reproducible joint clicking during mandibular opening and closing;
- Permanent dentition with full cognitive and communicative ability;
- Signed informed consent with good treatment compliance.
Who cannot join
- Non-reducible disc displacement, osteoarthrosis, isolated myofascial pain, or other conditions not meeting diagnostic criteria;
- Receipt of other TMJ disorder treatments within the past 3 months;
- Presence of systemic diseases, psychiatric disorders, or impaired consciousness.
Trial locations and contacts
1 site in 1 country.
China1 site
School and Hospital of Stomatology, Fujian Medical University,
Fuzhou, Fujian, 350000
About this study
Official title: Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement: A Randomized Controlled Trial
This study evaluates a new, individualized treatment for adolescents with temporomandibular joint disorders (TMD) caused by bilateral, reducible disc displacement. Participants will undergo clinical and imaging examinations, including cone-beam CT (CBCT), MRI, and intraoral digital scanning to create three-dimensional models of the teeth and jaw. Based on these data, the study team will design and fabricate a personalized repositioning digital occlusal splint for each participant. Patients will be instructed on how to wear the splint and will return for regular follow-up visits to monitor symptoms and adjust the splint as needed. The study aims to improve pain, chewing function, and overall quality of life. All research-related imaging, digital scans, splint fabrication, and follow-up visits will be provided at no cost to participants. Possible risks include temporary discomfort or pressure when first wearing the splint, and the possibility that symptoms may not improve as expected. Participant safety, privacy, and data confidentiality will be strictly protected, and participants may withdraw from the study at any time without affecting their future medical care.
Read the detailed description
Detailed Description This study evaluates four different methods for mandibular repositioning in patients with bilateral reducible temporomandibular joint (TMJ) disc displacement requiring occlusal reconstruction.
Methods of Mandibular Repositioning:
- Intraoral Direct Positioning Group: The therapeutic jaw position is determined clinically using the clicking elimination method, where patients open wide until clicking occurs, then gradually retract the mandible while performing opening-closing movements to find the minimal protrusion position without clicking.
- Articulator Positioning Group: Uses mechanical facebow transfer and semi-adjustable articulator (Artex CR) with condylar guidance parameters obtained from protrusive and lateral excursion records. The therapeutic position is determined by analyzing CBCT joint space measurements and MRI disc displacement data.
- Digital Anatomical Positioning Group: Combines intraoral scanning data with CBCT-reconstructed 3D jaw models. The therapeutic position is determined by referencing MRI disc reduction phase, optimal joint space ratios, and anatomical landmarks using CAD software (Exocad).
- Digital Jaw Motion Tracking Group: Integrates 3D jaw models with electronic jaw tracking data (Zebris). The therapeutic position is determined by analyzing condylar movement trajectories (identifying the "figure-8" pattern crossover points indicating disc displacement) combined with dynamic MRI and optimal joint space parameters.
Treatment Protocol: All groups receive digitally designed and manufactured repositioning splints. Patients wear splints 24 hours daily (except during meals) for 3 months, with follow-up adjustments at 2 weeks, 1 month, 2 months, and 3 months.
Imaging Protocol:
- CBCT (I-CAT FLX): 120 kV, 5 mA, 0.2 mm resolution
- MRI (GE Discovery MR750w 3.0T): Bilateral TMJ surface coils, oblique sagittal and coronal views in closed-mouth position, oblique sagittal in maximum opening
Assessment Methods:
- Joint space measurements using Ikeda's method on registered pre- and post-treatment CBCT images
- Condyle position analysis using Gelb 4/7 position criteria
- Disc-condyle angle measurement on MRI (>15° defined as disc displacement)
- Being tested
- Clinical Clicking Elimination Repositioning Splint, Adjustable Articulator Repositioning Splint, CAD-Designed Anatomical Repositioning Splint, Electronic Jaw Tracking Repositioning Splint
- Keywords
- Reducible disc displacement, Mandibular repositioning, Occlusal splint therapy, Digital dentistry, CBCT, Electronic facebow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Clicking Elimination Repositioning SplintDevice
A custom-fabricated hard acrylic repositioning splint based on manual intraoral mandibular positioning. The splint is created by:
- Clinically identifying the optimal jaw position through clicking elimination technique
- Taking alginate impressions of maxillary and mandibular arches
- Pouring stone models and manually adjusting mandibular model to the determined position
- Fabricating a hard acrylic splint with 1-2 mm occlusal clearance
- Finishing and polishing the splint Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months.
Adjustable Articulator Repositioning SplintDevice
A custom-fabricated hard acrylic repositioning splint using adjustable articulator (Artex CR) methodology:
- Performing mechanical facebow transfer
- Recording condylar guidance parameters in protrusive and lateral excursions
- Analyzing CBCT joint space measurements and MRI disc displacement data
- Mounting study models on Artex CR articulator with precise condylar settings
- Manually adjusting splint to achieve optimal mandibular position
- Fabricating hard acrylic splint with 1-2 mm occlusal clearance Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months.
CAD-Designed Anatomical Repositioning SplintDevice
A digitally designed and 3D-printed repositioning splint using advanced digital workflow:
- Performing intraoral digital scanning (iTero Element)
- Acquiring CBCT scan (I-CAT FLX)
- Importing MRI disc displacement data
- Using CAD software (Exocad) to:
- Overlay intraoral scan with CBCT 3D model
- Reference MRI disc reduction phase
- Calculate optimal joint space ratios
- Digitally designing splint with precise mandibular positioning
- Fabricating hard acrylic splint with 1-2 mm occlusal clearance Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months.
Electronic Jaw Tracking Repositioning SplintDevice
A digitally designed repositioning splint using electronic jaw motion tracking:
- Performing 3D jaw motion tracking (Zebris JMA system)
- Capturing mandibular movement trajectories
- Identifying "figure-8" pattern crossover points indicating disc displacement
- Integrating dynamic MRI data
- Analyzing optimal joint space parameters
- Using CAD software to design precise mandibular positioning splint
- Fabricating hard acrylic splint with 1-2 mm occlusal clearance Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Direct Positioning | Active comparator | Therapeutic mandibular position is determined using the clinical clicking elimination method. Patients perform wide opening until clicking occurs, then gradually retract the mandible while making opening-closing movements to identify the minimal protrusion position without clicking. A repositioning splint is fabricated based on this position. Receives: Device: Clinical Clicking Elimination Repositioning Splint |
| Articulator Positioning | Experimental | Therapeutic mandibular position is determined using a semi-adjustable articulator (Artex CR) with mechanical facebow transfer. Condylar guidance angles are obtained from protrusive and lateral excursion records. The optimal position is calculated based on CBCT joint space measurements and MRI disc displacement data. A repositioning splint is fabricated accordingly. Receives: Device: Adjustable Articulator Repositioning Splint |
| Digital Anatomical Positioning | Experimental | Therapeutic mandibular position is determined by integrating intraoral scanning data with CBCT-reconstructed 3D jaw models using CAD software (Exocad). The optimal position is calculated by referencing MRI disc reduction phase, ideal joint space ratios (anterior:superior:posterior = 1:1.3:1), and anatomical landmarks. A repositioning splint is digitally designed and 3D-printed. Receives: Device: CAD-Designed Anatomical Repositioning Splint |
| Digital Jaw Motion Tracking | Experimental | Therapeutic mandibular position is determined by integrating 3D jaw models with electronic jaw tracking data (Zebris JMA system). The optimal position is identified by analyzing condylar movement trajectories, specifically locating the crossover points of the "figure-8" pattern indicating disc displacement, combined with dynamic MRI and joint space parameters. A repositioning splint is digitally designed and 3D-printed. Receives: Device: Electronic Jaw Tracking Repositioning Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Temporomandibular Joint Space Ratio
Quantitative assessment of changes in temporomandibular joint space using Cone Beam Computed Tomography (CBCT) with Ikeda's method.
Measured: Baseline and 3 months post-treatment
Change in Disc-Condyle Relationship Angle
Quantitative assessment of disc displacement using Magnetic Resonance Imaging (MRI) with angle measurement technique.
Measured: Baseline and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start20 Jun 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disc DisplacementStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of four parallel groups based on patient preference and clinical feasibility (non-randomized allocation): * Group A (Intraoral Direct Positioning): Therapeutic mandibular position determined by clinical clicking elimination method. * Group B (Articulator Positioning): Therapeutic position determined using semi-adjustable articulator with facebow transfer and condylar guidance records. * Group C (Digital Anatomical Positioning): Therapeutic position determined by integrating intraoral scanning, CBCT, and MRI data using CAD software. * Group D (Digital Jaw Motion Tracking): Therapeutic position determined
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Yu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345104
- Sponsor's protocol ID
- 2024GGA070
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 11 Feb 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07345104
- Acronym / sponsor ID
- 2024GGA070
- Keywords
- Reducible disc displacement, Mandibular repositioning, Occlusal splint therapy, Digital dentistry, CBCT, Electronic facebow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 15 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.
This study evaluates a new, individualized treatment for adolescents with temporomandibular joint disorders (TMD) caused by bilateral, reducible disc displacement. Participants will undergo clinical and imaging examinations, including cone-beam CT (CBCT), MRI, and intraoral digital scanning to create three-dimensional models of the teeth and jaw. Based on these data, the study team will design and fabricate a personalized repositioning digital occlusal splint for each participant. Patients will be instructed on how to wear the splint and will return for regular follow-up visits to monitor symptoms and adjust the splint as needed. The study aims to improve pain, chewing function, and overall quality of life. All research-related imaging, digital scans, splint fabrication, and follow-up visits will be provided at no cost to participants. Possible risks include temporary discomfort or pressure when first wearing the splint, and the possibility that symptoms may not improve as expected. Participant safety, privacy, and data confidentiality will be strictly protected, and participants may withdraw from the study at any time without affecting their future medical care.
Detailed description
Detailed Description This study evaluates four different methods for mandibular repositioning in patients with bilateral reducible temporomandibular joint (TMJ) disc displacement requiring occlusal reconstruction.
Methods of Mandibular Repositioning:
- Intraoral Direct Positioning Group: The therapeutic jaw position is determined clinically using the clicking elimination method, where patients open wide until clicking occurs, then gradually retract the mandible while performing opening-closing movements to find the minimal protrusion position without clicking.
- Articulator Positioning Group: Uses mechanical facebow transfer and semi-adjustable articulator (Artex CR) with condylar guidance parameters obtained from protrusive and lateral excursion records. The therapeutic position is determined by analyzing CBCT joint space measurements and MRI disc displacement data.
- Digital Anatomical Positioning Group: Combines intraoral scanning data with CBCT-reconstructed 3D jaw models. The therapeutic position is determined by referencing MRI disc reduction phase, optimal joint space ratios, and anatomical landmarks using CAD software (Exocad).
- Digital Jaw Motion Tracking Group: Integrates 3D jaw models with electronic jaw tracking data (Zebris). The therapeutic position is determined by analyzing condylar movement trajectories (identifying the "figure-8" pattern crossover points indicating disc displacement) combined with dynamic MRI and optimal joint space parameters.
Treatment Protocol: All groups receive digitally designed and manufactured repositioning splints. Patients wear splints 24 hours daily (except during meals) for 3 months, with follow-up adjustments at 2 weeks, 1 month, 2 months, and 3 months.
Imaging Protocol:
- CBCT (I-CAT FLX): 120 kV, 5 mA, 0.2 mm resolution
- MRI (GE Discovery MR750w 3.0T): Bilateral TMJ surface coils, oblique sagittal and coronal views in closed-mouth position, oblique sagittal in maximum opening
Assessment Methods:
- Joint space measurements using Ikeda's method on registered pre- and post-treatment CBCT images
- Condyle position analysis using Gelb 4/7 position criteria
- Disc-condyle angle measurement on MRI (>15° defined as disc displacement)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are assigned to one of four parallel groups based on patient preference and clinical feasibility (non-randomized allocation): * Group A (Intraoral Direct Positioning): Therapeutic mandibular position determined by clinical clicking elimination method. * Group B (Articulator Positioning): Therapeutic position determined using semi-adjustable articulator with facebow transfer and condylar guidance records. * Group C (Digital Anatomical Positioning): Therapeutic position determined by integrating intraoral scanning, CBCT, and MRI data using CAD software. * Group D (Digital Jaw Motion Tracking): Therapeutic position determined
| Arm | Type | Receives |
|---|---|---|
| Intraoral Direct Positioning | Active comparator | Device: Clinical Clicking Elimination Repositioning SplintTherapeutic mandibular position is determined using the clinical clicking elimination method. Patients perform wide opening until clicking occurs, then gradually retract the mandible while making opening-closing movements to identify the minimal protrusion position without clicking. A repositioning splint is fabricated based on this position. |
| Articulator Positioning | Experimental | Device: Adjustable Articulator Repositioning SplintTherapeutic mandibular position is determined using a semi-adjustable articulator (Artex CR) with mechanical facebow transfer. Condylar guidance angles are obtained from protrusive and lateral excursion records. The optimal position is calculated based on CBCT joint space measurements and MRI disc displacement data. A repositioning splint is fabricated accordingly. |
| Digital Anatomical Positioning | Experimental | Device: CAD-Designed Anatomical Repositioning SplintTherapeutic mandibular position is determined by integrating intraoral scanning data with CBCT-reconstructed 3D jaw models using CAD software (Exocad). The optimal position is calculated by referencing MRI disc reduction phase, ideal joint space ratios (anterior:superior:posterior = 1:1.3:1), and anatomical landmarks. A repositioning splint is digitally designed and 3D-printed. |
| Digital Jaw Motion Tracking | Experimental | Device: Electronic Jaw Tracking Repositioning SplintTherapeutic mandibular position is determined by integrating 3D jaw models with electronic jaw tracking data (Zebris JMA system). The optimal position is identified by analyzing condylar movement trajectories, specifically locating the crossover points of the "figure-8" pattern indicating disc displacement, combined with dynamic MRI and joint space parameters. A repositioning splint is digitally designed and 3D-printed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of reducible temporomandibular joint (TMJ) disc displacement according to the 2014 revised criteria of the International Association for Dental Research;
- Bilateral reducible disc displacement confirmed by MRI;
- Reproducible joint clicking during mandibular opening and closing;
- Permanent dentition with full cognitive and communicative ability;
- Signed informed consent with good treatment compliance.
Key exclusion criteria (3 listed)
- Non-reducible disc displacement, osteoarthrosis, isolated myofascial pain, or other conditions not meeting diagnostic criteria;
- Receipt of other TMJ disorder treatments within the past 3 months;
- Presence of systemic diseases, psychiatric disorders, or impaired consciousness.
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 |
|---|---|---|
| Clinical Clicking Elimination Repositioning SplintA custom-fabricated hard acrylic repositioning splint based on manual intraoral mandibular positioning. The splint is created by: 1. Clinically identifying the optimal jaw position through clicking elimination technique 2. Taking alginate impressions of maxillary and mandibular arches 3. Pouring stone models and manually adjusting mandibular model to the determined position 4. Fabricating a hard acrylic splint with 1-2 mm occlusal clearance 5. Finishing and polishing the splint Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months. | Device | Intraoral Direct Positioning |
| Adjustable Articulator Repositioning SplintA custom-fabricated hard acrylic repositioning splint using adjustable articulator (Artex CR) methodology: 1. Performing mechanical facebow transfer 2. Recording condylar guidance parameters in protrusive and lateral excursions 3. Analyzing CBCT joint space measurements and MRI disc displacement data 4. Mounting study models on Artex CR articulator with precise condylar settings 5. Manually adjusting splint to achieve optimal mandibular position 6. Fabricating hard acrylic splint with 1-2 mm occlusal clearance Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months. | Device | Articulator Positioning |
| CAD-Designed Anatomical Repositioning SplintA digitally designed and 3D-printed repositioning splint using advanced digital workflow: 1. Performing intraoral digital scanning (iTero Element) 2. Acquiring CBCT scan (I-CAT FLX) 3. Importing MRI disc displacement data 4. Using CAD software (Exocad) to: * Overlay intraoral scan with CBCT 3D model * Reference MRI disc reduction phase * Calculate optimal joint space ratios 5. Digitally designing splint with precise mandibular positioning 6. Fabricating hard acrylic splint with 1-2 mm occlusal clearance Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months. | Device | Digital Anatomical Positioning |
| Electronic Jaw Tracking Repositioning SplintA digitally designed repositioning splint using electronic jaw motion tracking: 1. Performing 3D jaw motion tracking (Zebris JMA system) 2. Capturing mandibular movement trajectories 3. Identifying "figure-8" pattern crossover points indicating disc displacement 4. Integrating dynamic MRI data 5. Analyzing optimal joint space parameters 6. Using CAD software to design precise mandibular positioning splint 7. Fabricating hard acrylic splint with 1-2 mm occlusal clearance Patients wear the splint 24 hours daily (except during meals) for 3 months, with adjustments at 2 weeks, 1 month, 2 months, and 3 months. | Device | Digital Jaw Motion Tracking |
Primary outcome
Change in Temporomandibular Joint Space Ratio
Time frame: Baseline and 3 months post-treatment
Quantitative assessment of changes in temporomandibular joint space using Cone Beam Computed Tomography (CBCT) with Ikeda's method.
Change in Disc-Condyle Relationship Angle
Time frame: Baseline and 3 months post-treatment
Quantitative assessment of disc displacement using Magnetic Resonance Imaging (MRI) with angle measurement technique.
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 11 Feb 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.
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 Clinical Clicking Elimination Repositioning Splint, Adjustable Articulator Repositioning Splint and CAD-Designed Anatomical Repositioning Splint in people with Temporomandibular Joint Disc Displacement, run by Fujian Medical University at 1 site in China.
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 5 inclusion and 3 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 11 Feb 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 China. 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?
Change in Temporomandibular Joint Space Ratio (time frame: Baseline and 3 months post-treatment). 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 11 Feb 2026.