Edentulous Alveolar RidgeNCT07104370
Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
A study testing Bone augmentation using an autologous bone block, Bone augmentation using freeze-dried allograft block and preoperative cone beam computed tomography (CBCT) in people with Edentulous Alveolar Ridge and Edentulous Alveolar Ridge Atrophy, run by Semmelweis University at 1 site in Hungary.
Trial summary
After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge, Edentulous Alveolar Ridge Atrophy
- What is being tested?
- Bone augmentation using an autologous bone block, Bone augmentation using freeze-dried allograft block and preoperative cone beam computed tomography (CBCT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 29 Sep 2025to 1 Sep 2033
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- require lateral augmentation for implant rehabilitation
Who cannot join
- Smoking
- Pregnancy
- Poor oral hygiene
- Failure to attend follow-up visits
- Therapeutic-dose irradiation to the head and neck region
- Local bone tumors, cysts, or inflammatory processes
Show all 9Show fewer
- Decompensated systemic diseases contraindicate surgery
- Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
- Psychiatric disorders contraindicate implant rehabilitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Department of Public Dental Health
Budapest, Hungary, 1088
Csilla dr. Szerencse, 0614591500 ext. 55890, szerencse.csilla@semmelweis.hu
About this study
Official title: Comparison of Freeze-dried Bone Allograft and Autogenous Bone Blocks in the Surgical Reconstruction of Horizontally Atrophied Jaws for Implant Placement: Randomized Clinical Trial
After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation.
Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties.
Read more
The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing.
The aim of the study is:
- to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used,
- compare the microarchitecture of the augmented bone depending on the bone graft material applied,
- to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
- Being tested
- Bone augmentation using an autologous bone block, Bone augmentation using freeze-dried allograft block, preoperative cone beam computed tomography (CBCT), post-operative cone beam computed tomography (CBCT), Dental implant placement
- Keywords
- autologous bone, retromolar area, bone block, bone augmentation, dental implant, freeze-dried bone allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone augmentation using an autologous bone blockProcedure or surgery
- Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.
- In the control group, an autologous bone block graft is harvested from the retromolar donor area using rotary instruments and piezoelectric surgery.
- The block is fixed to the recipient site with two screws.
- The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.
- Sutures are removed two weeks postoperatively.
- All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In the case of an amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.
- Patients do not wear temporary prostheses during the healing period.
Bone augmentation using freeze-dried allograft blockProcedure or surgery
- Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.
- In the test group, a freeze-dried allograft bone block is prepared to the required size using rotary instruments.
- The block is fixed to the recipient site with two screws.
- The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.
- Sutures are removed two weeks postoperatively.
- All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In case of amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.
- Patients do not wear temporary prostheses during the healing period.
preoperative cone beam computed tomography (CBCT)Diagnostic test
- Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.
post-operative cone beam computed tomography (CBCT)Diagnostic test
Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.
Dental implant placementProcedure or surgery
Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia.
Bone core biopsyDiagnostic test
At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
Fixed dental prosthesis (FDP) fabricationProcedure or surgery
After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.
Bone graftingDevice
Freeze-dried bone allograft block
| Study group | Role | What they receive |
|---|---|---|
| Freeze-dried allograft bone block | Experimental | A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw. Receives: Procedure: Bone augmentation using freeze-dried allograft block; Diagnostic Test: preoperative cone beam computed tomography (CBCT); Diagnostic Test: post-operative cone beam computed tomography (CBCT); Procedure: Dental implant placement; Diagnostic Test: Bone core biopsy; Procedure: Fixed dental prosthesis (FDP) fabrication; Device: Bone grafting |
| Autogenous bone block | Active comparator | An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw. Receives: Procedure: Bone augmentation using an autologous bone block; Diagnostic Test: preoperative cone beam computed tomography (CBCT); Diagnostic Test: post-operative cone beam computed tomography (CBCT); Procedure: Dental implant placement; Diagnostic Test: Bone core biopsy; Procedure: Fixed dental prosthesis (FDP) fabrication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the bone augmentation
The bone augmentation surgery is successful if no inflammatory complications occur in the 3-month healing period and the bone volume is sufficient for dental implant placement.
Measured: 3 months
Success of the dental implants
According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference.
- Success (optimum health)
- No pain or tenderness upon function
- 0 mobility
- Less than 2 mm radiographic bone loss from initial surgery
- No exudates in the patient's history
II. Satisfactory survival
- No pain on function
- 0 mobility
- 2-4 mm radiographic bone loss
- No exudates in the patient's history
III. Compromised survival
- May have sensitivity to the function
- No mobility
- Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body)
- Probing depth more than 7 mm
- May have exudates in the patient's history
IV. Failure (clinical or absolute failure)
Any of the following:
- Pain on function
- Mobility
- Radiographic bone loss of more than 1/2 the length of the implant
- Uncontrolled exudate
- Implant no longer in the mouth
Measured: 3 months
Success of the implant-borne prostheses
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
Measured: 5 years
Secondary outcomes (11)
Hisomorphometry: Percent of residual bone graft particles
The percentage of residual bone graft particle area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Measured: 3-6 months
Hisomorphometry: Percent of newly formed bone
The percentage of newly formed bone area is measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%).
Measured: 3-6 months
Hisomorphometry: Percent of bone marrow
The percentage of bone marrow area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Measured: 3-6 months
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples
Relative volume of calcified tissue in the selected volume. Unit: none
Measured: 3-6 months
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples
Ratio of the segmented bone surface to the total volume in the region of interest. Unit: 1/mm
Measured: 3-6 months
Value of the trabecular thickness (Tb.Th.) calculated from the microCT reconstructions of the bone core biopsy samples.
Mean thickness of the trabeculae, assessed using direct 3D methods. Unit: mm.
Measured: 3-6 months
Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.
Mean distance between the trabeculae, assessed using direct 3D methods. Unit: mm.
Measured: 3-6 months
Value of the trabecular bone pattern factor (Tb.Pf), derived from microCT reconstructions of bone core biopsy samples.
An indicator of the relation between convex and concave elements in the trabecular bone structure. Tb.Pf <0 when the trabecular bone is honeycomb-like and increases as the trabecular bone acquires a rod-like structure. Unit: none.
Measured: 3-6 months
Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.
The estimator of the plate-versus rod-like characteristic of the trabecular bone structure, 0 for perfect plates, 3 for perfect rods, and 4 for perfect spheres. Unit: none.
Measured: 3-6 months
Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.
Percent porosity is the volume of pores as a percent of the total volume of interest (VOI). Unit: percent (%).
Measured: 3-6 months
Value of the Connectivity (Conn), calculated from the microCT reconstructions of the bone core biopsy samples.
One useful and fast algorithm for calculating the Euler connectivity in 3D is the "Conneulor". It measures what might be called "redundant connectivity", the degree to which parts of the object are multiply connected. It is a measure of how many connections in a structure can be severed before the structure falls into two separate pieces. Unit: none.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start29 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Semmelweis 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Szerencse Csilla, Semmelweis University
- Investigators
- Csilla Szerencse, DMD, MDS, Principal investigator, Department of Public Dental Health Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104370
- Sponsor's protocol ID
- SEDCD45
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Freeze-dried Bone Allograft and Autogenous Bone Blocks in the Surgical Reconstruction of Horizontally Atrophied Jaws for Implant Placement: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07104370
- Acronym / sponsor ID
- SEDCD45
- Keywords
- autologous bone, retromolar area, bone block, bone augmentation, dental implant, freeze-dried bone allograft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2033 (estimated)
- First posted
- 5 Aug 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.
After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation.
Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties.
The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing.
The aim of the study is:
- to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used,
- compare the microarchitecture of the augmented bone depending on the bone graft material applied,
- to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze-dried allograft bone block | Experimental | Procedure: Bone augmentation using freeze-dried allograft block, Diagnostic Test: preoperative cone beam computed tomography (CBCT), Diagnostic Test: post-operative cone beam computed tomography (CBCT), Procedure: Dental implant placement, Diagnostic Test: Bone core biopsy, Procedure: Fixed dental prosthesis (FDP) fabrication, Device: Bone graftingA freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw. |
| Autogenous bone block | Active comparator | Procedure: Bone augmentation using an autologous bone block, Diagnostic Test: preoperative cone beam computed tomography (CBCT), Diagnostic Test: post-operative cone beam computed tomography (CBCT), Procedure: Dental implant placement, Diagnostic Test: Bone core biopsy, Procedure: Fixed dental prosthesis (FDP) fabricationAn autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years old
- require lateral augmentation for implant rehabilitation
Key exclusion criteria (9 listed)
- Smoking
- Pregnancy
- Poor oral hygiene
- Failure to attend follow-up visits
- Therapeutic-dose irradiation to the head and neck region
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 |
|---|---|---|
| Bone augmentation using an autologous bone block* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap. * In the control group, an autologous bone block graft is harvested from the retromolar donor area using rotary instruments and piezoelectric surgery. * The block is fixed to the recipient site with two screws. * The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures. * Sutures are removed two weeks postoperatively. * All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In the case of an amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided. * Patients do not wear temporary prostheses during the healing period. | Procedure or surgery | Autogenous bone block |
| Bone augmentation using freeze-dried allograft block* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap. * In the test group, a freeze-dried allograft bone block is prepared to the required size using rotary instruments. * The block is fixed to the recipient site with two screws. * The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures. * Sutures are removed two weeks postoperatively. * All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In case of amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided. * Patients do not wear temporary prostheses during the healing period. | Procedure or surgery | Freeze-dried allograft bone block |
| preoperative cone beam computed tomography (CBCT)• Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region. | Diagnostic test | Autogenous bone block, Freeze-dried allograft bone block |
| post-operative cone beam computed tomography (CBCT)Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation. | Diagnostic test | Autogenous bone block, Freeze-dried allograft bone block |
| Dental implant placementFollowing the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia. | Procedure or surgery | Autogenous bone block, Freeze-dried allograft bone block |
| Bone core biopsyAt the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis. | Diagnostic test | Autogenous bone block, Freeze-dried allograft bone block |
| Fixed dental prosthesis (FDP) fabricationAfter 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants. | Procedure or surgery | Autogenous bone block, Freeze-dried allograft bone block |
| Bone graftingFreeze-dried bone allograft block | Device | Freeze-dried allograft bone block |
Primary outcome
Success of the bone augmentation
Time frame: 3 months
The bone augmentation surgery is successful if no inflammatory complications occur in the 3-month healing period and the bone volume is sufficient for dental implant placement.
Success of the dental implants
Time frame: 3 months
According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. I. Success (optimum health) 1. No pain or tenderness upon function 2. 0 mobility 3. Less than 2 mm radiographic bone loss from initial surgery 4. No exudates in the patient's history II. Satisfactory survival 1. No pain on function 2. 0 mobility 3. 2-4 mm radiographic bone loss 4. No exudates in the patient's history III. Compromised survival 1. May have sensitivity to the function 2. No mobility 3. Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body) 4. Probing depth more than 7 mm 5. May have exudates in the patient's history IV. Failure (clinical or absolute failure) Any of the following: 1. Pain on function 2. Mobility 3. Radiographic bone loss of more than 1/2 the length of the implant 4. Uncontrolled exudate 5. Implant no longer in the mouth
Success of the implant-borne prostheses
Time frame: 5 years
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
11 secondary outcomes
Hisomorphometry: Percent of residual bone graft particles
Time frame: 3-6 months
Hisomorphometry: Percent of newly formed bone
Time frame: 3-6 months
Hisomorphometry: Percent of bone marrow
Time frame: 3-6 months
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples
Time frame: 3-6 months
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples
Time frame: 3-6 months
Value of the trabecular thickness (Tb.Th.) calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the trabecular bone pattern factor (Tb.Pf), derived from microCT reconstructions of bone core biopsy samples.
Time frame: 3-6 months
Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 months
Value of the Connectivity (Conn), calculated from the microCT reconstructions of the bone core biopsy samples.
Time frame: 3-6 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 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published after de-identification.
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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.
Csilla Szerencse, DMD, MDS principal investigator
Department of Public Dental Health Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone augmentation using an autologous bone block, Bone augmentation using freeze-dried allograft block and preoperative cone beam computed tomography (CBCT) in people with Edentulous Alveolar Ridge and Edentulous Alveolar Ridge Atrophy, run by Semmelweis University at 1 site in Hungary.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Oct 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 Hungary. 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?
Contact Csilla Szerencse, DMD, MDS (003614591500 ext. 55890, szerencse.csilla@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the bone augmentation (time frame: 3 months). The study lists 3 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 3 Oct 2025.