Dental ImplantNCT06517030
Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
A study testing Tooth Extraction, Immediate Implant Placement and Socket reconstruction with DBBB+HA in people with Dental Implant, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
The present research is a national multicentric prospective parallel double-blinded (both the patient and the examiner are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE (conformité européenne) marking, used according to the intended use subject to the CE… Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Tooth Extraction, Immediate Implant Placement and Socket reconstruction with DBBB+HA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2025to Sep 2025
- 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 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial.
- In good general health as evidenced by medical history.
- Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single implant-supported fixed prosthetic rehabilitation.
- Presence of >3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
- In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites, full mouth plaque score < 20% and full-mouth bleeding score < 20%).
Who cannot join
- Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
- Presence of inflammatory and autoimmune disease of the oral cavity.
- Severe or poorly controlled diabetes or previous radiotherapy of head area.
- Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
- Individuals who are smokers of >10 cigarettes/day.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Presence of <3mm of dehiscence of buccal walls of the socket after tooth extraction.
- Presence of a distance between the interdental bone crest and buccal bone crest <3 mm after tooth extraction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, Mi
Giovanna Laura Di Domenico, DDS, 0226432806, giovannalauradd@gmail.com
About this study
Official title: Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.
The present research is a national multicentric prospective parallel double-blinded (both the patient and the examiner are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE (conformité européenne) marking, used according to the intended use subject to the CE marking.
The hypothesis tested is: the socket reconstruction procedure performed in conjunction with Immediate implant placement (IIP) with the use of Deproteinized bovine bone mineral + hyaluronic acid (DBBM+HA, Cerabone plus) leads to a greater increase in the vertical buccal bone height than same procedure with deproteinized bovine bone mineral alone (DBBM, Bio-oss Collagen).
Read the detailed description
The present research is a national multicentric prospective parallel double-blinded (both the patient and the investigator who will perform the measurements are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE marking, used according to the intended use subject to the CE marking.
The hypothesis tested is: the socket reconstruction procedure performed in conjunction with IIP with the use of DBBM+HA leads to a greater increase in the vertical buccal bone height than same procedure with DBBM alone.
The present study will be reported according to the CONSORT statement for improving the quality of reports of parallel-group randomized trials (http://www.consort-statement.org/).
Patients will be randomly treated by means of IIP+connective tissue graft (CTG)+DBBM+HA (Test group or A group) or IIP+CTG+DBBM (Control group or B group). A randomization list will be generated in blocks: patients will be divided in 3 blocks according to the study center (M=San Raffaele Hospital, Milan; B=University of Bologna; S=University of Siena) and the treatment will be assigned at random in each block to ensure a balanced distribution of the tested interventions, with a ratio test:control=1:1. The investigator who will generate the allocation sequence will not be the person who will determine eligibility and entry of patients. The assignments (A or B group) will enclose in serially numbered, opaque, sealed envelopes, each bearing on the outside only the letter corresponding to the name of the center (M, B, S) and a number (from 1 to 10). A designated investigator for each center will be responsible to ensure that the envelopes will be opened sequentially, and only after the patient will undergo extraction of the hopeless tooth, implant placement, and clinical measurement assessment. For each patient, a sequential number will be assigned based on the date of enrollment, and the envelope with the corresponding number will be opened for each of them.
Both the investigator who will perform the measurements and the patients will be blinded to the randomization. The principal investigator (PI) will make sure patients are blind by simply not telling them there is a difference between the two medical devices; while he will ensure that investigator (who will perform the measurements) is blind by assigning a code or an identifying number to the two treatment groups so that they cannot know which device has been used.
Patients will be followed for 6 months after surgery.
The undermentioned 5 follow-up visits, which are standard of practice for all implant-bearing patients, will be scheduled for each patient for both treatment groups at:
- 7±2 days post-surgery - clinical and photographic examination, collection of VAS (Visual Analogue Scale).
- 14±4 days post-surgery - suture removal, clinical and photographic examination.
- 1 month±7 days post-surgery - clinical and photographic examination.
- 3 months±5 days post-surgery - clinical and photographic examination, measurements of the following parameters: Gingival recession depth (REC in mm), Keratinized tissue width (KTW in mm), Soft tissue thickness (GT in mm), Pocket probing depth (PPD in mm), Bleeding on probing (BoP), Plaque index (PI).
- 6 months ±1 month post-surgery - clinical and photographic examination, CBCT scan, periapical radiography, 3D digital dental impression, measurements of the following parameters: Gingival recession depth (REC in mm), Keratinized tissue width (KTW in mm), Pocket probing depth (PPD in mm), Bleeding on probing (BoP), Plaque index (PI).
After the visit at 6 months, each patient will then be considered "off study" (e.g. subject has completed treatment and all follow-up visits).
- Conditions
- Dental Implant
- Being tested
- Tooth Extraction, Immediate Implant Placement, Socket reconstruction with DBBB+HA, Socket reconstruction with DBBB, CTG placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth ExtractionProcedure or surgery
After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.
Immediate Implant PlacementProcedure or surgery
After providing that the extraction socket will meet the inclusion criteria, an implant will be immediately inserted with 1 mm of its transmucosal portion positioned under the interproximal bone crest.
Socket reconstruction with DBBB+HAProcedure or surgery
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (DBBM+HA).
Socket reconstruction with DBBBProcedure or surgery
The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).
CTG placementProcedure or surgery
Once the appropriate healing abutments will be installed, a CTG will be utilized as a barrier membrane. Then, the buccal flap will be coronally advanced and will be adapted to the healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| Test group (DBBM+HA) | Experimental | In Test group, the gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (Botiss Cerabone Plus; Botiss biomaterials, Hauptstr. 28 15806 Zossen, Germany). The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment. Receives: Procedure: Tooth Extraction; Procedure: Immediate Implant Placement; Procedure: Socket reconstruction with DBBB+HA; Procedure: CTG placement |
| Control group (DBBM) | Active comparator | In Control group, deproteinized bovine bone mineral (DBBM) (Bio-Oss Collagen; Geistlich Pharma, Wolhusen, Switzerland) will be positioned in the gap. The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment. Receives: Procedure: Tooth Extraction; Procedure: Immediate Implant Placement; Procedure: Socket reconstruction with DBBB; Procedure: CTG placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical buccal bone height changes (∆VBBH).
the vertical linear distance from point A (the most coronal point of the buccal crest of the baseline socket) to point B (the most coronal point of the buccal crest at 6 months after implant insertion)
Measured: at baseline and at 6 months after procedure
Secondary outcomes (9)
Width of keratinized tissue (KTW).
Measured at the buccal aspect, as the distance between gingival margin and mucogingival junction.
Measured: at baseline and at 6 months after treatment.
Soft tissue contour changes.
Linear and volumetric measurements will be performed using Stl files superimposition.
Measured: at baseline and at 6 months after treatment.
Soft tissue thickness (STT).
Superimposition of DICOM file, representing hard tissue volume, to STL file representing soft tissue contour, will be used to measure the buccal soft tissue thickness in the two different treatment groups.
Measured: at baseline and at 6 months after treatment.
Horizontal Buccal Bone Changes.
The horizontal linear distance between the outer surface of buccal bone at baseline and that at 6 months will be evaluated.
Measured: at baseline and at 6 months after treatment.
Osseous Ridge Width Changes.
the horizontal linear distance from the outer surface of buccal bone to the outer surface of palatal/lingual bone, measured at baseline and at 6 months. The osseous ridge width changes in millimetres (mm) and in percentage (%ORR) will be also calculated.
Measured: at baseline and at 6 months after treatment.
Wound healing index (WHI).
The following criteria will be used:
- score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence + intact papillae height
- score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration + reduced papillae height
- score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration + loss of papillae height
Measured: at 7 and 14 days after treatment.
Post-surgical pain (PP)
Subjects will be also asked to evaluate pain perception at day 7 and day 14 using a visual analogue scale (VAS) score (0 = no pain 10 = maximal pain).
Measured: at 7 and 14 days after treatment.
Amount of drug intake
The daily consumption of analgesics/anti-inflammatory medications from the day of surgery until day 14 will be calculated.
Measured: from the day of surgery until day 14
Handling of materials.
The clinical handling of the two grafts will be assessed retrospectively by the surgeons using a visual analogue scale (VAS, 0 = easy to be applied, 10 = very difficult to be applied)
Measured: at the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study startApr 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Model description
- The present research is a national multicentric prospective parallel double-blinded (both the patient and the investigator who will perform the measurements are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE marking, used according to the intended use subject to the CE marking.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo de Sanctis, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517030
- Sponsor's protocol ID
- Botiss-1
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2024
- Last updated
- 16 Apr 2025
- 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 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06517030
- Acronym / sponsor ID
- Botiss-1
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Jul 2024 (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.
The present research is a national multicentric prospective parallel double-blinded (both the patient and the examiner are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE (conformité européenne) marking, used according to the intended use subject to the CE marking.
The hypothesis tested is: the socket reconstruction procedure performed in conjunction with Immediate implant placement (IIP) with the use of Deproteinized bovine bone mineral + hyaluronic acid (DBBM+HA, Cerabone plus) leads to a greater increase in the vertical buccal bone height than same procedure with deproteinized bovine bone mineral alone (DBBM, Bio-oss Collagen).
Detailed description
The present research is a national multicentric prospective parallel double-blinded (both the patient and the investigator who will perform the measurements are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE marking, used according to the intended use subject to the CE marking.
The hypothesis tested is: the socket reconstruction procedure performed in conjunction with IIP with the use of DBBM+HA leads to a greater increase in the vertical buccal bone height than same procedure with DBBM alone.
The present study will be reported according to the CONSORT statement for improving the quality of reports of parallel-group randomized trials (http://www.consort-statement.org/).
Patients will be randomly treated by means of IIP+connective tissue graft (CTG)+DBBM+HA (Test group or A group) or IIP+CTG+DBBM (Control group or B group). A randomization list will be generated in blocks: patients will be divided in 3 blocks according to the study center (M=San Raffaele Hospital, Milan; B=University of Bologna; S=University of Siena) and the treatment will be assigned at random in each block to ensure a balanced distribution of the tested interventions, with a ratio test:control=1:1. The investigator who will generate the allocation sequence will not be the person who will determine eligibility and entry of patients. The assignments (A or B group) will enclose in serially numbered, opaque, sealed envelopes, each bearing on the outside only the letter corresponding to the name of the center (M, B, S) and a number (from 1 to 10). A designated investigator for each center will be responsible to ensure that the envelopes will be opened sequentially, and only after the patient will undergo extraction of the hopeless tooth, implant placement, and clinical measurement assessment. For each patient, a sequential number will be assigned based on the date of enrollment, and the envelope with the corresponding number will be opened for each of them.
Both the investigator who will perform the measurements and the patients will be blinded to the randomization. The principal investigator (PI) will make sure patients are blind by simply not telling them there is a difference between the two medical devices; while he will ensure that investigator (who will perform the measurements) is blind by assigning a code or an identifying number to the two treatment groups so that they cannot know which device has been used.
Patients will be followed for 6 months after surgery.
The undermentioned 5 follow-up visits, which are standard of practice for all implant-bearing patients, will be scheduled for each patient for both treatment groups at:
- 7±2 days post-surgery - clinical and photographic examination, collection of VAS (Visual Analogue Scale).
- 14±4 days post-surgery - suture removal, clinical and photographic examination.
- 1 month±7 days post-surgery - clinical and photographic examination.
- 3 months±5 days post-surgery - clinical and photographic examination, measurements of the following parameters: Gingival recession depth (REC in mm), Keratinized tissue width (KTW in mm), Soft tissue thickness (GT in mm), Pocket probing depth (PPD in mm), Bleeding on probing (BoP), Plaque index (PI).
- 6 months ±1 month post-surgery - clinical and photographic examination, CBCT scan, periapical radiography, 3D digital dental impression, measurements of the following parameters: Gingival recession depth (REC in mm), Keratinized tissue width (KTW in mm), Pocket probing depth (PPD in mm), Bleeding on probing (BoP), Plaque index (PI).
After the visit at 6 months, each patient will then be considered "off study" (e.g. subject has completed treatment and all follow-up visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The present research is a national multicentric prospective parallel double-blinded (both the patient and the investigator who will perform the measurements are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE marking, used according to the intended use subject to the CE marking.
| Arm | Type | Receives |
|---|---|---|
| Test group (DBBM+HA) | Experimental | Procedure: Tooth Extraction, Procedure: Immediate Implant Placement, Procedure: Socket reconstruction with DBBB+HA, Procedure: CTG placementIn Test group, the gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (Botiss Cerabone Plus; Botiss biomaterials, Hauptstr. 28 15806 Zossen, Germany). The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment. |
| Control group (DBBM) | Active comparator | Procedure: Tooth Extraction, Procedure: Immediate Implant Placement, Procedure: Socket reconstruction with DBBB, Procedure: CTG placementIn Control group, deproteinized bovine bone mineral (DBBM) (Bio-Oss Collagen; Geistlich Pharma, Wolhusen, Switzerland) will be positioned in the gap. The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the trial.
- In good general health as evidenced by medical history.
- Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single implant-supported fixed prosthetic rehabilitation.
- Presence of >3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
- In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites, full mouth plaque score < 20% and full-mouth bleeding score < 20%).
Key exclusion criteria (8 listed)
- Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
- Presence of inflammatory and autoimmune disease of the oral cavity.
- Severe or poorly controlled diabetes or previous radiotherapy of head area.
- Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
- Individuals who are smokers of >10 cigarettes/day.
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 |
|---|---|---|
| Tooth ExtractionAfter local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically. | Procedure or surgery | Control group (DBBM), Test group (DBBM+HA) |
| Immediate Implant PlacementAfter providing that the extraction socket will meet the inclusion criteria, an implant will be immediately inserted with 1 mm of its transmucosal portion positioned under the interproximal bone crest. | Procedure or surgery | Control group (DBBM), Test group (DBBM+HA) |
| Socket reconstruction with DBBB+HAThe gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (DBBM+HA). | Procedure or surgery | Test group (DBBM+HA) |
| Socket reconstruction with DBBBThe gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM). | Procedure or surgery | Control group (DBBM) |
| CTG placementOnce the appropriate healing abutments will be installed, a CTG will be utilized as a barrier membrane. Then, the buccal flap will be coronally advanced and will be adapted to the healing abutment. | Procedure or surgery | Control group (DBBM), Test group (DBBM+HA) |
Primary outcome
Vertical buccal bone height changes (∆VBBH).
Time frame: at baseline and at 6 months after procedure
the vertical linear distance from point A (the most coronal point of the buccal crest of the baseline socket) to point B (the most coronal point of the buccal crest at 6 months after implant insertion)
9 secondary outcomes
Width of keratinized tissue (KTW).
Time frame: at baseline and at 6 months after treatment.
Soft tissue contour changes.
Time frame: at baseline and at 6 months after treatment.
Soft tissue thickness (STT).
Time frame: at baseline and at 6 months after treatment.
Horizontal Buccal Bone Changes.
Time frame: at baseline and at 6 months after treatment.
Osseous Ridge Width Changes.
Time frame: at baseline and at 6 months after treatment.
Wound healing index (WHI).
Time frame: at 7 and 14 days after treatment.
Post-surgical pain (PP)
Time frame: at 7 and 14 days after treatment.
Amount of drug intake
Time frame: from the day of surgery until day 14
Handling of materials.
Time frame: at the day of the surgery
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 16 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth Extraction, Immediate Implant Placement and Socket reconstruction with DBBB+HA in people with Dental Implant, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 8 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 16 Apr 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 Italy. 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 Giovanna Laura Di Domenico (+393485826742, giovannalauradd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical buccal bone height changes (∆VBBH). (time frame: at baseline and at 6 months after procedure). 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 16 Apr 2025.