Class III MalocclusionNCT06877780
Evaluation of Pain and Functional Impairments When Treating Class III Malocclusion Using Two Treatment Procedures
A study testing RMR with SME and BAIMT with RME in people with Class III Malocclusion and Maxillary Deficiency, run by Damascus University at 1 site in Syria.
Trial summary
A clinical examination of each recalled candidate patient will be carried out at Adib Al Lahham Centre at the Ministry of Health Damascus to ensure that he/she meets the inclusion criteria. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Class III Malocclusion, Maxillary Deficiency
- What is being tested?
- RMR with SME and BAIMT with RME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSyria
- Study dates
- 1 Sep 2021to 1 Sep 2023
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Growing patients between the ages of 12-15 of either gender.
- Angle's class III malocclusion.
- Skeletal class III (-4 < ANB < + 1).
- Anterior crossbite involving two or more teeth or edge-to-edge incisor relationship with or without a forward shift of the mandible during closure.
- The incisor mandibular plane's (IMPA) angle should be between 85° and 100°.
- Maxillary constriction necessitates expansion.
Who cannot join
- Skeletal class III malocclusion is mainly caused by maxillary retrognathism.
- Severe skeletal class III, mainly resulting from mandibular prognathism.
- Contraindications for the application of the mini-screws.
- The presence of supernumerary teeth or missing ones except for the third molars.
- The presence of cleft lip or craniofacial syndromes and/or palate abnormalities.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Damascus, DM20 HAJ72
About this study
Official title: Patient-reported Outcome Measures of Two Different Treatment Protocols to Manage Growing Patients With Skeletal Class III and Maxillary Constriction: A Randomized Controlled Trial
A clinical examination of each recalled candidate patient will be carried out at Adib Al Lahham Centre at the Ministry of Health Damascus to ensure that he/she meets the inclusion criteria. Following obtaining the full records, including a lateral cephalometric radiograph, additional checking will be made to classify the skeletal relationship (class III relationship) of each possible candidate for this work.
This trial compares two groups of patients who suffered from Class III malocclusion associated with maxillary constriction.
Read more
Experimental Group: Patients in this group will undergo treatment using bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion (RME).
Control Group: Patients in this group will undergo treatment using a removable mandibular retractor (RMR) associated with slow maxillary expansion (SME).
Read the detailed description
Treating skeletal Class III malocclusion presents challenges. However, various methods have been implemented for treating Class III cases through growth modification during the primary and mixed dentition stages, such as the removable mandibular retractor (RMR) and recently bone-anchored intermaxillary traction (BAIMT) system. In orthodontics, there has been increasing interest in assessing patient-reported outcome measures (PROMs) for two reasons: First, the patient's psychosocial well-being enhances collaboration during treatment. Second, the results of orthodontic treatment may advance if the patient is informed and self-assured regarding their treatment.
Participants will be chosen from patients attending the Adib Al Lahham Centre at the Ministry of Health Damascus. Eligible patients with Class III malocclusion associated with maxillary constriction who meet the inclusion criteria will be asked to participate in this study following a screening conducted by the researcher. Informed consent will be acquired from all patients who consent to participate in the survey after receiving an information sheet.
For BAIMT with the RME group, a modified Hyrax palatal expander with posterior bite planes will be bonded. The expander will also have hooks welded distal to the first molars to attach elastic bands. Two self-drilling mini screws will be inserted buccally between the roots of the mandibular canine and the first premolar. Then, intermaxillary elastics will be placed between the hooks and the mandibular.
FOR RMR with SME group, patients in this group will be provided with an RMR appliance containing a midline split that included an expansion screw, and an anterior sagittal expansion screw which will be utilized when necessary to rectify the upper incisors axes.
A change in the relationship of the incisor from a negative overjet to a positive one (i.e., + 1.5 mm or greater) will be deemed a sign of successful treatment in the sagittal plane. If the defect in the transverse plane is addressed first, the expansion will be halted, and the patient will be asked to keep wearing the appliance until the deficiency in the sagittal plane is corrected. On the other hand, if the defect in the sagittal plane is corrected initially, the process will be reversed.
The levels of pain, functional impairment, and confidence will be self-reported using a questionnaire with a 4-point Likert scale administered at five evaluation times during the first 6 months of treatment initiation.
- Conditions
- Class III Malocclusion, Maxillary Deficiency
- Being tested
- RMR with SME, BAIMT with RME
- Medical subject headings
- Malocclusion, Angle Class III, Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMR with SMEDevice
The RMR will be used in conjunction with slow maxillary expansion
BAIMT with RMEDevice
The bone-anchored intermaxillary traction will be used with rapid maxillary expansion
| Study group | Role | What they receive |
|---|---|---|
| Removable mandibular retractor with slow maxillary expansion | Active comparator | Patients in this group will undergo treatment using a removable mandibular retractor (RMR) associated with slow maxillary expansion (SME). Receives: Device: RMR with SME |
| Bone-anchored intermaxillary traction with rapid maxillary expansion | Experimental | Patients in this group will undergo treatment using bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion (RME). Receives: Device: BAIMT with RME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the feeling of pressure at the soft tissues
Patients will be asked to identify their pressure at the soft tissues by asking, " Do you suffer from pressure at the soft tissues while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).
Measured: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Change in the perception of pain
Patients will be asked to identify their pain perception by answering, " Do you suffer from pain while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).
Measured: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Secondary outcomes (4)
Change in speech difficulties
Patients will be asked to identify their perception of speech difficulties by answering, " Do you suffer from speech difficulties while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).
Measured: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Change in the swallowing difficulties
Patients will be asked to identify their perception of swallowing disability by answering, " Do you suffer from a swallowing disability while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).
Measured: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Change in the limitation in the movement of the mandible.
Patients will be asked to identify their perception of limitation in the movement of the mandible by answering, "Do you suffer from a limitation in the movement of the mandible while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3)
Measured: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Change in the feeling of embarrassment
Patients will be asked to identify their shame by asking, " Do you feel ashamed while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).
Measured: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Sep 2021
- Primary completion15 Jul 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Class III MalocclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Sponsor
- Investigators
- Ahmad S. Zakaria, DDS MSc, Principal investigator, Department of Orthodontics, School of Dental Sciences, USM Health Campus, Kelantan, MalaysiaRozita Hassan, DDS MSc PhD, Study chair, Department of Orthodontics, School of Dental Sciences, USM Health Campus, Kelantan, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877780
- Sponsor's protocol ID
- UDDS-Ortho-5-2025
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abed Al Jawad FH, Alhashimi NA. Evaluation of self-perceived pain and jaw function impairment in children undergoing slow and rapid maxillary expansion. Angle Orthod. 2021 Nov 1;91(6):725-732. doi: 10.2319/020221-100.1.
PubMed 34033675Rabah N, Al-Ibrahim HM, Hajeer MY, Ajaj MA, Mahmoud G. Assessment of Patient-Centered Outcomes When Treating Maxillary Constriction Using a Slow Removable Versus a Rapid Fixed Expansion Appliance in the Adolescence Period: A Randomized Controlled Trial. Cureus. 2022 Mar 3;14(3):e22793. doi: 10.7759/cureus.22793. eCollection 2022 Mar.
PubMed 35261839Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.
PubMed 23758461Ryan FS, Cunningham SJ. Patient-reported outcome measures and orthodontics. J Orthod. 2018 Jun;45(2):63-64. doi: 10.1080/14653125.2018.1472729. No abstract available.
PubMed 29857794Sergl HG, Zentner A. A comparative assessment of acceptance of different types of functional appliances. Eur J Orthod. 1998 Oct;20(5):517-24. doi: 10.1093/ejo/20.5.517.
PubMed 9825554Zakaria AS, Hassan R, Baharin F, Alfailany DT, Hajeer MY, Al-Hamod IA, Al-Sabbagh R. Evaluation of Patient-reported Outcome Measures during the Correction of Skeletal Class III Malocclusion with Maxillary Constriction in Early Adolescence. J Contemp Dent Pract. 2025 Jun 1;26(6):598-607. doi: 10.5005/jp-journals-10024-3901.
PubMed 41040030
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcome Measures of Two Different Treatment Protocols to Manage Growing Patients With Skeletal Class III and Maxillary Constriction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06877780
- Acronym / sponsor ID
- UDDS-Ortho-5-2025
- Conditions
- Class III Malocclusion, Maxillary Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 14 Mar 2025 (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.
A clinical examination of each recalled candidate patient will be carried out at Adib Al Lahham Centre at the Ministry of Health Damascus to ensure that he/she meets the inclusion criteria. Following obtaining the full records, including a lateral cephalometric radiograph, additional checking will be made to classify the skeletal relationship (class III relationship) of each possible candidate for this work.
This trial compares two groups of patients who suffered from Class III malocclusion associated with maxillary constriction.
Experimental Group: Patients in this group will undergo treatment using bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion (RME).
Control Group: Patients in this group will undergo treatment using a removable mandibular retractor (RMR) associated with slow maxillary expansion (SME).
Detailed description
Treating skeletal Class III malocclusion presents challenges. However, various methods have been implemented for treating Class III cases through growth modification during the primary and mixed dentition stages, such as the removable mandibular retractor (RMR) and recently bone-anchored intermaxillary traction (BAIMT) system. In orthodontics, there has been increasing interest in assessing patient-reported outcome measures (PROMs) for two reasons: First, the patient's psychosocial well-being enhances collaboration during treatment. Second, the results of orthodontic treatment may advance if the patient is informed and self-assured regarding their treatment.
Participants will be chosen from patients attending the Adib Al Lahham Centre at the Ministry of Health Damascus. Eligible patients with Class III malocclusion associated with maxillary constriction who meet the inclusion criteria will be asked to participate in this study following a screening conducted by the researcher. Informed consent will be acquired from all patients who consent to participate in the survey after receiving an information sheet.
For BAIMT with the RME group, a modified Hyrax palatal expander with posterior bite planes will be bonded. The expander will also have hooks welded distal to the first molars to attach elastic bands. Two self-drilling mini screws will be inserted buccally between the roots of the mandibular canine and the first premolar. Then, intermaxillary elastics will be placed between the hooks and the mandibular.
FOR RMR with SME group, patients in this group will be provided with an RMR appliance containing a midline split that included an expansion screw, and an anterior sagittal expansion screw which will be utilized when necessary to rectify the upper incisors axes.
A change in the relationship of the incisor from a negative overjet to a positive one (i.e., + 1.5 mm or greater) will be deemed a sign of successful treatment in the sagittal plane. If the defect in the transverse plane is addressed first, the expansion will be halted, and the patient will be asked to keep wearing the appliance until the deficiency in the sagittal plane is corrected. On the other hand, if the defect in the sagittal plane is corrected initially, the process will be reversed.
The levels of pain, functional impairment, and confidence will be self-reported using a questionnaire with a 4-point Likert scale administered at five evaluation times during the first 6 months of treatment initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removable mandibular retractor with slow maxillary expansion | Active comparator | Device: RMR with SMEPatients in this group will undergo treatment using a removable mandibular retractor (RMR) associated with slow maxillary expansion (SME). |
| Bone-anchored intermaxillary traction with rapid maxillary expansion | Experimental | Device: BAIMT with RMEPatients in this group will undergo treatment using bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion (RME). |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Growing patients between the ages of 12-15 of either gender.
- Angle's class III malocclusion.
- Skeletal class III (-4 < ANB < + 1).
- Anterior crossbite involving two or more teeth or edge-to-edge incisor relationship with or without a forward shift of the mandible during closure.
- The incisor mandibular plane's (IMPA) angle should be between 85° and 100°.
Key exclusion criteria (5 listed)
- Skeletal class III malocclusion is mainly caused by maxillary retrognathism.
- Severe skeletal class III, mainly resulting from mandibular prognathism.
- Contraindications for the application of the mini-screws.
- The presence of supernumerary teeth or missing ones except for the third molars.
- The presence of cleft lip or craniofacial syndromes and/or palate abnormalities.
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 |
|---|---|---|
| RMR with SMEThe RMR will be used in conjunction with slow maxillary expansion | Device | Removable mandibular retractor with slow maxillary expansion |
| BAIMT with RMEThe bone-anchored intermaxillary traction will be used with rapid maxillary expansion | Device | Bone-anchored intermaxillary traction with rapid maxillary expansion |
Primary outcome
Change in the feeling of pressure at the soft tissues
Time frame: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Patients will be asked to identify their pressure at the soft tissues by asking, " Do you suffer from pressure at the soft tissues while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).
Change in the perception of pain
Time frame: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Patients will be asked to identify their pain perception by answering, " Do you suffer from pain while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).
4 secondary outcomes
Change in speech difficulties
Time frame: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Change in the swallowing difficulties
Time frame: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Change in the limitation in the movement of the mandible.
Time frame: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
Change in the feeling of embarrassment
Time frame: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.
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 17 Mar 2025.
- Background: PubMed 34033675Abed Al Jawad FH, Alhashimi NA. Evaluation of self-perceived pain and jaw function impairment in children undergoing slow and rapid maxillary expansion. Angle Orthod. 2021 Nov 1;91(6):725-732. doi: 10.2319/020221-100.1.
- Background: PubMed 35261839Rabah N, Al-Ibrahim HM, Hajeer MY, Ajaj MA, Mahmoud G. Assessment of Patient-Centered Outcomes When Treating Maxillary Constriction Using a Slow Removable Versus a Rapid Fixed Expansion Appliance in the Adolescence Period: A Randomized Controlled Trial. Cureus. 2022 Mar 3;14(3):e22793. doi: 10.7759/cureus.22793. eCollection 2022 Mar.
- Background: PubMed 23758461Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.
- Background: PubMed 29857794Ryan FS, Cunningham SJ. Patient-reported outcome measures and orthodontics. J Orthod. 2018 Jun;45(2):63-64. doi: 10.1080/14653125.2018.1472729. No abstract available.
- Background: PubMed 9825554Sergl HG, Zentner A. A comparative assessment of acceptance of different types of functional appliances. Eur J Orthod. 1998 Oct;20(5):517-24. doi: 10.1093/ejo/20.5.517.
- Derived from this study: PubMed 41040030Zakaria AS, Hassan R, Baharin F, Alfailany DT, Hajeer MY, Al-Hamod IA, Al-Sabbagh R. Evaluation of Patient-reported Outcome Measures during the Correction of Skeletal Class III Malocclusion with Maxillary Constriction in Early Adolescence. J Contemp Dent Pract. 2025 Jun 1;26(6):598-607. doi: 10.5005/jp-journals-10024-3901.
- 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.
Ahmad S. Zakaria, DDS MSc principal investigator
Department of Orthodontics, School of Dental Sciences, USM Health Campus, Kelantan, Malaysia
Rozita Hassan, DDS MSc PhD study chair
Department of Orthodontics, School of Dental Sciences, USM Health Campus, Kelantan, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RMR with SME and BAIMT with RME in people with Class III Malocclusion and Maxillary Deficiency, run by Damascus University at 1 site in Syria.
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 6 inclusion and 5 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 17 Mar 2025. 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 Syria. 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 the feeling of pressure at the soft tissues (time frame: The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.). 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?
On the ClinicalTrials.gov record for NCT06877780, which also lists 6 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 17 Mar 2025.