Alveolar Ridge AugmentationNCT06027710
Allograft Ridge Augmentation: 3D Analysis of CAD/CAM Custom Milled and Prefabricated Conventional Allogeneic Bone Blocks and Dental Implant Follow-up
An observational study of Alveolar Ridge Augmentation, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
To rehabilitate patients after the loss of their own teeth, dental implants are nowadays the therapy of choice if the indication is suitable. In order to successfully place implants in the patient's jaw, a sufficient supply of bone in vertical and horizontal dimensions is necessary. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jan 2023to 1 Sep 2023
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient treatment records of the study center of the last 12 years will be filtered for the treatment under investigation and eligibility criteria described and, if criteria are met, üatients are included in the retrospective analysis.
Who may be able to join
- Treated with the defined allogeneic bone substitute material
- Received the defined standardized intervention
- Number of missing teeth in the bone defect region ≥ 3
- 3 CBCT scans recorded and available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)
Who cannot join
- Treated with a different bone substitute material than the one defined for investigation
- Received an other intervention than the defined standardized procedure
- Number of missing teeth in the bone defect region < 3
- One of the following CBCT scans not available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Stomatology, Faculty of Dentistry, University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782
About this study
Official title: Remodeling of Prefabricated Conventional and CAD/CAM Custom Fabricated Allograft Blocks for Bone Augmentation - Volumetric Analysis and Dental Implant Follow-up
To rehabilitate patients after the loss of their own teeth, dental implants are nowadays the therapy of choice if the indication is suitable. In order to successfully place implants in the patient's jaw, a sufficient supply of bone in vertical and horizontal dimensions is necessary. Human bone is generally always in the process of reconstruction and changes over time. If there is not enough substance left for rehabilitation with implants due to previous degradation of the alveolar bone, bone augmentation can be performed. For this purpose, mainly autogenous, xenogenic or allogenic bone material is used.
Bone augmentation using allografts shows satisfactory results in clinical use and has advantages such as elimination of morbidity associated with autogenous bone graft harvesting. In addition to the use of conventional and prefabricated graft blocks, it is now possible to produce individual allogeneic bone blocks using computer-aided design based on the patient's radiological data. After this bone has been placed in the patient, it can be restored with implants after a healing phase of about 6 months.
Read more
In order to make the treatment as predictable as possible, it is crucial to know how a bone augmentation changes over time and whether bone remodelling or resorption occurs. How allogeneic bone blocks behave with regard to their stability and treatment success has already been investigated in some studies, but to date there is no study that deals with the difference between prefabricated, conventional and individually manufactured CAD/CAM allogeneic bone blocks.
By retrospectively analysing existing clinical data, the aim is to compare how the two methods, prefabricated bone blocks and CAD/CAM-fabricated bone blocks, perform during the healing phase.
A virtual volume analysis method of 3D digital imaging data (cone beam computed tomography scans) will be performed, which allows not only linear punctual evaluation but also area and volumetric analysis. Furthermore, the in the grafts inserted dental implants will be examined in terms of survival rate, complication rate and marginal bone loss by evaluation of the available follow-up records of up to 12 years.
Read the detailed description
A clinical retrospective cohort study is planned in a non-invasive, observational study design.
The study will be conducted at a single university centre: the Department of Department of Stomatology (Periodontology), Faculty of Dentistry, University of Santiago de Compostela, Spain.
The study will be conducted in the following steps:
- Identification of the patient population: The cohort for the retrospective study will be filtered from the patient data of the Department of Stomatology (Periodontology) of the University of Santiago de Compostela. Data from all patients who have received one of the following two treatments in the last 12 years will be selected and examined:
- Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks.
- Group B: horizontal and/or vertical augmentation of allogeneic bone graft material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; Type: individually planned, CAD/CAM-produced bone blocks
- Data extraction: The following clinical data of the patients are collected for retrospective analysis:
- The patients anamnesis with age at the time of surgery, gender, smoking habits at the time of surgery and during the period of follow-up examinations up to 12 years after surgery
- The patients treatment history: Statements about the treatment and follow-up examinations during the period up to 12 years after the intervention, statements about adverse events and complications during the intervention or in the period of follow-up examinations up to 12 years after surgery, intraoral clinical photographs The following radiological data of patients from both groups are used for evaluation: cone beam computed tomography data sets for volumetric evaluation and conventional x-rays for implant follow-up investigation. In detail the last CBCT scan before surgery (preoperative, t=0); the first CBCT scan directly after surgery (postoperative, t=1); the CBCT scan at 6 months after surgery (control, t=2); all periapical X-rays in the follow-up period of maximum 12 years after the surgery (Follow-up 1, Follow-up 2, Follow-up 3...) of the bone blocks and the therein inserted implants. To ensure that no conclusion be drawn about the identity of the patient, the data are pseudonymised by the investigating clinicians. The following type of pseudonymisation of the data takes place: the evaluation of the data is pseudonymised, i.e. the patient's name is replaced by another characteristic (number and letter, e.g. patient 1a, patient 2a, etc.). In this way, cases can be distinguished from patients and no conclusions can be drawn about patients.
- Digital data analysis: Standard tesselation langugage (STL) data are evaluated linearly and also volumetrically. First, STL models are created from the patients' DICOM data. The pre-operative model serves as the baseline model for each patient. This data is imported into CAD analysis software (GOM Inspect, GOM GmbH, Braunschweig, Germany). A region of interest is determined for each patient by precisely defining the margins of each graft when the reference model (t=0) is merged on the postoperative (t=1) and control model (t=2). Subsequently, the discrepancy at the ROI surface of both baseline and follow-up models can be calculated and is evaluated both linearly and volumetrically.
- Implant follow-up and analysis of mean marginal bone loss: The implant survival rate and complication rate (biological and technical) will be analysed with the patient history data available in the follow-up period of maximum 12 years after the intervention. Mean marginal bone loss will be measured in orthograde periapical x-rays mesial and distal of the implants installed in the allogenic grafts. The periapical x-rays after loading serve as baseline and the radiological bone loss in the maximum follow-up period available is measured.
- Statistical analysis:
To compare the change in the overlapping CBCT data of the two groups A and B after surgery and at follow-up examinations, a descriptive analysis is performed using SPSS Statistics (Version 22, IBM Corp., Armonk, NY) for the sum of the deviations on the x-, y- and z-axes. Statistical analyses are performed at both patient and material level. For each test, p-values with a significance level of p<0.05 will be used.
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft
- Keywords
- Allograft, Dental Implants, Bone Substitutes, Three-dimensional Imaging, Alveolar Ridge Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graftProcedure or surgery
Alveolar ridge augmentation procedure for extensive bone defect rehabilitation in the upper and/or lower jaw allogeneic bone blocks; dental implant insertion in allogeneic bone graft for oral rehabilitation after 6 month of healing
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated allogeneic bone blocks | Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks. Receives: Procedure: Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft | |
| CAD/CAM custom milled allogeneic bone blocks | - Group B: horizontal and/or vertical augmentation of allogeneic bone replacement material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: individually planned, CAD/CAM custom-produced bone blocks Receives: Procedure: Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone graft volume (Vol, in mm³)
Mean bone graft volume within the region of interest, measured in STL models derived from CBCT scans after the grafting procedure (t=1) and at 6 months follow-up (t=2) from baseline (t=0)
Measured: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline
Secondary outcomes (4)
Mean linear distance (in mm)
The mean linear deviation of the surface (comparison) of two subjects within the region of interest measured at STL models surface at t1 and t2 from baseline
Measured: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline
Mean marginal bone loss (in mm)
The radiological bone loss during the follow-up period available measured in periapical x-rays mesial and distal of the implant shoulder; compared to x-rax record after loading;
Measured: Maximum available follow-up period: from the beginning of the retrospective data analysis period, starting with the radiograph after implant loading until the last available follow-up radiograph; up to a maximum of 11 years, individually for each patient
Implant survival rate
Analysis, if the implant is in-situ at the follow-up examination; its condition is not specified
Measured: Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient
Implant complication rate (biological and technical)
t Type and frequency of complications are analysed for each implant and prosthesis
Measured: Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start21 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge AugmentationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Responsible party
- Principal investigator, Juan Blanco Carrión, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027710
- Sponsor's protocol ID
- USC 68/2022
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seidel A, Leira Y, Batalla P, Caneiro L, Wichmann M, Blanco J. Three-dimensional imaging analysis of CAD/CAM custom-milled versus prefabricated allogeneic block remodelling at 6 months and long-term follow-up of dental implants: A retrospective cohort study. J Clin Periodontol. 2024 Aug;51(8):1005-1016. doi: 10.1111/jcpe.13995. Epub 2024 May 6.
PubMed 38710641
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remodeling of Prefabricated Conventional and CAD/CAM Custom Fabricated Allograft Blocks for Bone Augmentation - Volumetric Analysis and Dental Implant Follow-up
- ClinicalTrials.gov ID
- NCT06027710
- Acronym / sponsor ID
- USC 68/2022
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- Allograft, Dental Implants, Bone Substitutes, Three-dimensional Imaging, Alveolar Ridge Augmentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 7 Sep 2023 (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.
To rehabilitate patients after the loss of their own teeth, dental implants are nowadays the therapy of choice if the indication is suitable. In order to successfully place implants in the patient's jaw, a sufficient supply of bone in vertical and horizontal dimensions is necessary. Human bone is generally always in the process of reconstruction and changes over time. If there is not enough substance left for rehabilitation with implants due to previous degradation of the alveolar bone, bone augmentation can be performed. For this purpose, mainly autogenous, xenogenic or allogenic bone material is used.
Bone augmentation using allografts shows satisfactory results in clinical use and has advantages such as elimination of morbidity associated with autogenous bone graft harvesting. In addition to the use of conventional and prefabricated graft blocks, it is now possible to produce individual allogeneic bone blocks using computer-aided design based on the patient's radiological data. After this bone has been placed in the patient, it can be restored with implants after a healing phase of about 6 months.
In order to make the treatment as predictable as possible, it is crucial to know how a bone augmentation changes over time and whether bone remodelling or resorption occurs. How allogeneic bone blocks behave with regard to their stability and treatment success has already been investigated in some studies, but to date there is no study that deals with the difference between prefabricated, conventional and individually manufactured CAD/CAM allogeneic bone blocks.
By retrospectively analysing existing clinical data, the aim is to compare how the two methods, prefabricated bone blocks and CAD/CAM-fabricated bone blocks, perform during the healing phase.
A virtual volume analysis method of 3D digital imaging data (cone beam computed tomography scans) will be performed, which allows not only linear punctual evaluation but also area and volumetric analysis. Furthermore, the in the grafts inserted dental implants will be examined in terms of survival rate, complication rate and marginal bone loss by evaluation of the available follow-up records of up to 12 years.
Detailed description
A clinical retrospective cohort study is planned in a non-invasive, observational study design.
The study will be conducted at a single university centre: the Department of Department of Stomatology (Periodontology), Faculty of Dentistry, University of Santiago de Compostela, Spain.
The study will be conducted in the following steps:
- Identification of the patient population: The cohort for the retrospective study will be filtered from the patient data of the Department of Stomatology (Periodontology) of the University of Santiago de Compostela. Data from all patients who have received one of the following two treatments in the last 12 years will be selected and examined:
- Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks.
- Group B: horizontal and/or vertical augmentation of allogeneic bone graft material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; Type: individually planned, CAD/CAM-produced bone blocks
- Data extraction: The following clinical data of the patients are collected for retrospective analysis:
- The patients anamnesis with age at the time of surgery, gender, smoking habits at the time of surgery and during the period of follow-up examinations up to 12 years after surgery
- The patients treatment history: Statements about the treatment and follow-up examinations during the period up to 12 years after the intervention, statements about adverse events and complications during the intervention or in the period of follow-up examinations up to 12 years after surgery, intraoral clinical photographs The following radiological data of patients from both groups are used for evaluation: cone beam computed tomography data sets for volumetric evaluation and conventional x-rays for implant follow-up investigation. In detail the last CBCT scan before surgery (preoperative, t=0); the first CBCT scan directly after surgery (postoperative, t=1); the CBCT scan at 6 months after surgery (control, t=2); all periapical X-rays in the follow-up period of maximum 12 years after the surgery (Follow-up 1, Follow-up 2, Follow-up 3...) of the bone blocks and the therein inserted implants. To ensure that no conclusion be drawn about the identity of the patient, the data are pseudonymised by the investigating clinicians. The following type of pseudonymisation of the data takes place: the evaluation of the data is pseudonymised, i.e. the patient's name is replaced by another characteristic (number and letter, e.g. patient 1a, patient 2a, etc.). In this way, cases can be distinguished from patients and no conclusions can be drawn about patients.
- Digital data analysis: Standard tesselation langugage (STL) data are evaluated linearly and also volumetrically. First, STL models are created from the patients' DICOM data. The pre-operative model serves as the baseline model for each patient. This data is imported into CAD analysis software (GOM Inspect, GOM GmbH, Braunschweig, Germany). A region of interest is determined for each patient by precisely defining the margins of each graft when the reference model (t=0) is merged on the postoperative (t=1) and control model (t=2). Subsequently, the discrepancy at the ROI surface of both baseline and follow-up models can be calculated and is evaluated both linearly and volumetrically.
- Implant follow-up and analysis of mean marginal bone loss: The implant survival rate and complication rate (biological and technical) will be analysed with the patient history data available in the follow-up period of maximum 12 years after the intervention. Mean marginal bone loss will be measured in orthograde periapical x-rays mesial and distal of the implants installed in the allogenic grafts. The periapical x-rays after loading serve as baseline and the radiological bone loss in the maximum follow-up period available is measured.
- Statistical analysis:
To compare the change in the overlapping CBCT data of the two groups A and B after surgery and at follow-up examinations, a descriptive analysis is performed using SPSS Statistics (Version 22, IBM Corp., Armonk, NY) for the sum of the deviations on the x-, y- and z-axes. Statistical analyses are performed at both patient and material level. For each test, p-values with a significance level of p<0.05 will be used.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prefabricated allogeneic bone blocks | – | Procedure: Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graftGroup A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks. |
| CAD/CAM custom milled allogeneic bone blocks | – | Procedure: Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft- Group B: horizontal and/or vertical augmentation of allogeneic bone replacement material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: individually planned, CAD/CAM custom-produced bone blocks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treatment records of the study center of the last 12 years will be filtered for the treatment under investigation and eligibility criteria described and, if criteria are met, üatients are included in the retrospective analysis.
Key inclusion criteria (4 listed)
- Treated with the defined allogeneic bone substitute material
- Received the defined standardized intervention
- Number of missing teeth in the bone defect region ≥ 3
- 3 CBCT scans recorded and available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)
Key exclusion criteria (4 listed)
- Treated with a different bone substitute material than the one defined for investigation
- Received an other intervention than the defined standardized procedure
- Number of missing teeth in the bone defect region < 3
- One of the following CBCT scans not available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)
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 |
|---|---|---|
| Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graftAlveolar ridge augmentation procedure for extensive bone defect rehabilitation in the upper and/or lower jaw allogeneic bone blocks; dental implant insertion in allogeneic bone graft for oral rehabilitation after 6 month of healing | Procedure or surgery | CAD/CAM custom milled allogeneic bone blocks, Prefabricated allogeneic bone blocks |
Primary outcome
Bone graft volume (Vol, in mm³)
Time frame: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline
Mean bone graft volume within the region of interest, measured in STL models derived from CBCT scans after the grafting procedure (t=1) and at 6 months follow-up (t=2) from baseline (t=0)
4 secondary outcomes
Mean linear distance (in mm)
Time frame: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline
Mean marginal bone loss (in mm)
Time frame: Maximum available follow-up period: from the beginning of the retrospective data analysis period, starting with the radiograph after implant loading until the last available follow-up radiograph; up to a maximum of 11 years, individually for each patient
Implant survival rate
Time frame: Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient
Implant complication rate (biological and technical)
Time frame: Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 38710641Seidel A, Leira Y, Batalla P, Caneiro L, Wichmann M, Blanco J. Three-dimensional imaging analysis of CAD/CAM custom-milled versus prefabricated allogeneic block remodelling at 6 months and long-term follow-up of dental implants: A retrospective cohort study. J Clin Periodontol. 2024 Aug;51(8):1005-1016. doi: 10.1111/jcpe.13995. Epub 2024 May 6.
- 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?
An observational study of Alveolar Ridge Augmentation, run by University of Santiago de Compostela at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. 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 Spain. 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?
Results are not available in the source record.
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?
Bone graft volume (Vol, in mm³) (time frame: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline). 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 NCT06027710, which also lists 1 linked publication.
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 7 Sep 2023.