Socket PreservationP-005NCT07099846
Hyaluronic Acid and Polynucleotides in Ridge Preservation
A study testing regeneration of post extraction socket with biomaterials in people with Socket Preservation and Implant-supported Single Crowns, run by University of Parma at 2 sites in Italy.
Trial summary
The aim of this study is to test the use of a bovine-derived bone graft combined with a polynucleotides-rich hyaluronic acid (PNHA) gel for the preservation of the bone after a tooth extraction (alveolar ridge preservation) and to test the performance of a fully-digital workflow to rehabilitate the site with a dental… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Socket Preservation, Implant-supported Single Crowns, Hyaluronic Acid
- What is being tested?
- regeneration of post extraction socket with biomaterials
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Jun 2025to May 2028
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥25-year-old males and females;
- good systemic health (self-assessment);
- presence of an unrestorable/hopeless tooth with periodontal attachment and buccal bone preserved at least for 2/3rd of the root and not associated with acute periapical pathology;
- full mouth bleeding and plaque scores ≤ 25%
Who cannot join
- uncontrolled or untreated periodontal disease;
- history of local (head and neck) radiation therapy in the past 5 years;
- acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible);
- medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. HIV-related disease);
- history of alcohol or drug abuse;
- smokers of ≥10 cigarettes a day;
- self-reported pregnancy or lactation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Centro di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma
Parma, 43126
Elena Calciolari, DDS, MS, PhD, +390521903640, elena.calciolari@unipr.it
Elena Calciolari, DDS, MS, PhD
- Recruiting
Centro di Odontoiatria
Parma, 43126
Elena Calciolari, DDS, MS, PhD, 0521903640, elena.calciolari@unipr.it
Federico Rivara, DDS, MS, PhD
About this study
Official title: The Use of Hyaluronic Acid and Polynucleotides in Ridge Preservation Sites Rehabilitated With a Complete Full Digital Workflow
The aim of this study is to test the use of a bovine-derived bone graft combined with a polynucleotides-rich hyaluronic acid (PNHA) gel for the preservation of the bone after a tooth extraction (alveolar ridge preservation) and to test the performance of a fully-digital workflow to rehabilitate the site with a dental implant. 40 patients in need for a single tooth extraction will be recruited at Centro di Odontoiatria, Università di Parma and they will be randomly assigned to 2 groups: extraction and spontaneous healing or extraction and regeneration of the site with a bovine-derived bone graft combined with a PNHA gel. At 4 months after extraction an implant will be placed in the extraction site, which will be rehabilitated with a fully-digital workflow and patients will be followed up at up to 12 months post rehabilitation. Two 3D x-rays with a small field of view will be performed immediately after extraction and at 4 months post extraction to plan implant placement. These images will also be used to assess changes in the dimension of the post extraction bone (primary outcome). As part of the study different questionnaires will be administered to assess quality of life and perception of the therapy and the wound exudate in the area of the extraction will be collected non invasively with a collagen sponge to assess the expression of different proteins during the early healing days. On the day of implant placement a sample of bone tissue will also be collected as part of the bone drilling and histologically analysed.
Read the detailed description
This is a single-centre, double-blind RCT involving 40 patients in need for a single tooth extraction to be replaced with a dental implant. The study consists of 11 visits, over a minimum period of 20 months. Participants will be recruited at Centro di Odontoiatria, at Università di Parma amongst patients routinely seen in new patient clinics and follow-up clinics. After atraumatic tooth extraction, participants will be randomly allocated to one of the following treatment groups: - DBBM (Bio-oss, Geistlich) mixed with a PNHA gel (Regenfast, Mastelli) and socket sealed with a porcine collagen matrix (Mucograft seal, Geistlich) (Test); - Unassisted socket healing (Control). Patient post-operative discomfort will be assessed with a visual analogue scale (VAS) and through clinician-reported post-operative oedema/swelling. Clinical evaluation of socket healing and recording of soft tissue healing index of Landry will also be performed during the early post-extraction days. With the help of a sterilecollagen sponge, wound exudate will be collected at 3, 7 and 14 days post extraction. A CBCT with a small field of view (e.g. 5X8 cm) will be taken to assess the post-extraction socket dimensions and after 4 months to plan implant placement. The CBCT scan will be processed with its embedded segmentation function to remove scattering defects and obtain the maximal possible quality.
Changes in alveolar ridge width from the extraction until 4 months post extraction between the 2 groups will be assessed with a dedicated software (e.g. SMOP) (primary outcome).
On the day of implant placement, a bone core biopsy will be collected from the drilling site. Undecalcified histology analysis will be done, and qualitative histology will be performed by a blind examiner, who will assess the level of maturation of the tissue in the two groups. Moreover, histomorphometric measurements will be recorded and presented descriptively, including amount of mineralized bone, as well as other standard parameters, such as %graft particles (test group only) and % of immature woven bone. A fully digital workflow will be followed to rehabilitate the patients, which will be followed up at up to 12 months post implant loading.
- Being tested
- regeneration of post extraction socket with biomaterials
- Keywords
- alveolar ridge preservation, hyaluronic acid, polynucleotides, digital workflow, CAD-CAM, Implant rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regeneration of post extraction socket with biomaterialsDevice
Also called alveolar ridge preservation, socket preservation
after tooth extraction, in the test group we will place a demineralised bovine bone graft mixed with a gel containing hyaluronic acid and polynucleotide and we will cover the entrance of the socket with a collagen matrix
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous post extraction healing | No intervention | The control group will not receive any biomaterial in the post extraction socket |
| Alveolar ridge preservation | Experimental | In the group assigned to receive socket preservation, particulate deproteinizied bovine bone mineral (Bio-oss, Geistlich biomaterials) mixed with a gel containing hyaluronic acid and polynucleotides (Regenfast, Mastelli) will be placed in the socket without overfilling it and the socket will be sealed with a porcine collagen matrix (Mucograft seal, Geistlich), Any remaining PNHA gel will be placed at the entrance of the socket and on the surrounding gingival tissue Receives: Device: regeneration of post extraction socket with biomaterials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar ridge width at 4 months post extraction between study groups
This is a superiority outcome evaluating horizontal ridge width changes at four months post-extraction between test and contro group with the help of a CBCT scan.
Measured: 4 months after tooth extraction (visit 6)
Secondary outcomes (12)
quality of newly formed bone
to qualitatively assess socket healing and the maturity of the newly formed bone when DBBM combined with a PNHA and covered by a collagen matrix is employed for alveolar ridge preservation as compared to unassisted healing . A bone core biopsy will be taken at 4 months in both groups and the percentage of connective tissue, woven bone and mineralised bone calculated
Measured: 4 months post extraction (visit 6)
3D volume changes
to assess 3D volume changes in soft and hard tissues at 4 and 12 months post extraction (this will be performed after digitally superimposing DICOM and STL files and in a selected region of interest) in the test and control groups
Measured: 4 months post extraction (visit 6)
changes in protein expression
to assess and compare the expression of proteins and signalling pathways in the wound exudate at early healing stages. This will be done through full proteomic analysis via mass spectrometry of the wound exudate
Measured: 3, 7 and 14 days post extraction (Visit 3, 4, 5)
Profilometric changes
to assess profilometric changes in the alveolar ridge via superimposition of intra oral scans of test and control groups
Measured: 3, 7, 14 days and at 4 months post extraction (visit 3, 4, 5)
Change in post operative discomfort
to assess changes in patient post-operative discomfort, interference with daily activities and oedema and clinician-reported post-operative oedema/swelling via visual analogue scale (VAS) scale going from 0 (no effect) to 10 (maximum negative effect)
Measured: 3, 7 and 14 days after extraction (visit 3, 4, 5)
Change in Landry healing index
to assess changes in soft tissue healing index of Landry (qualitative index measured with a visual scale) in the test and control groups
Measured: 3, 7 and 14 days after extraction (Visit 3, 4, 5)
Changes in keratinized tissue
to assess changes in keratinized tissue (KT) height (measured in mm) in the area of the extraction (with the help of a periodontal probe) in the test and control groups
Measured: 4 months post extraction (Visit 6) and at study termination 12 months post loading (Visit 10);
Qualitative assessment of post-operative need for medications
To record self-reported dosage and type of medications taken by the patients to control post operative pain in the test and control groups
Measured: Starting after extraction (visit 2) and until 14 days post extraction (Visit 3, 4, 5)
Possibility to prosthetically place an implant
To qualitatively describe the ability or not to place the implant in a prosthetically guided implant position with the endosteal portion of the implant completely in bone with more than 1-1.5 mm thickness on the buccal and oral aspect (Tonetti et al., 2023) (i.e. need for regeneration) at implant placement
Measured: implant placement (Visit 7 - within 5 months from tooth extraction)
Peri-implant radiographic bone level changes
To assess on peri-apical x-rays the changes in peri-implant bone levels (distance between bone crest and implant shoulder) in the 2 groups
Measured: at implant loading (visit 9 - within 5 months from implant placement) and at the end of the study (12 months post loading - visit 10)
Participants' satisfaction with treatment
To qualitatively report participants' satisfaction via visual analogue scale (VAS) scale going from 0 (worse) to 10 (maximum positive effect)
Measured: at the end of the study, 12 months post loading (Visit 10)
Implant torque
To qualitatively report implant torque, which is assessed with a torque wrench after surgically placing the implant and is measured in N/cm
Measured: Implant placement (visit 7 - within 5 months from tooth extraction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start9 Jun 2025
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Socket PreservationStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099846
- Sponsor's protocol ID
- P-005
- Acronym
- P-005
- Status last verified
- Aug 2025
- First submitted
- 8 May 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patients' data held will be coded and pseudo-anonymised with an alphanumerical code that will be kept separately from the personal data as name, surname, date and place of birth and sex and stored in a locked cabinet in the PI's office. The only people within the Centro di Odontoiatria who will have access to information that identifies the patients will be people who need to contact them about the research study, and make sure that relevant information about the study is recorded for their care, and to oversee the quality of the study or audit the data collection process. The people who analyse the information will not be able to identify patients and will not be able to find out their name or contact details.
Publications
Guizzardi S, Galli C, Govoni P, Boratto R, Cattarini G, Martini D, Belletti S, Scandroglio R. Polydeoxyribonucleotide (PDRN) promotes human osteoblast proliferation: a new proposal for bone tissue repair. Life Sci. 2003 Aug 29;73(15):1973-83. doi: 10.1016/s0024-3205(03)00547-2.
PubMed 12899922Colangelo MT, Govoni P, Belletti S, Squadrito F, Guizzardi S, Galli C. Polynucleotide biogel enhances tissue repair, matrix deposition and organization. J Biol Regul Homeost Agents. 2021 Jan-Feb;35(1):355-362. doi: 10.23812/20-320-L. No abstract available.
PubMed 33480222Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
PubMed 30623987
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Hyaluronic Acid and Polynucleotides in Ridge Preservation Sites Rehabilitated With a Complete Full Digital Workflow
- ClinicalTrials.gov ID
- NCT07099846
- Acronym / sponsor ID
- P-005 / P-005
- Keywords
- alveolar ridge preservation, hyaluronic acid, polynucleotides, digital workflow, CAD-CAM, Implant rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 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.
The aim of this study is to test the use of a bovine-derived bone graft combined with a polynucleotides-rich hyaluronic acid (PNHA) gel for the preservation of the bone after a tooth extraction (alveolar ridge preservation) and to test the performance of a fully-digital workflow to rehabilitate the site with a dental implant. 40 patients in need for a single tooth extraction will be recruited at Centro di Odontoiatria, Università di Parma and they will be randomly assigned to 2 groups: extraction and spontaneous healing or extraction and regeneration of the site with a bovine-derived bone graft combined with a PNHA gel. At 4 months after extraction an implant will be placed in the extraction site, which will be rehabilitated with a fully-digital workflow and patients will be followed up at up to 12 months post rehabilitation. Two 3D x-rays with a small field of view will be performed immediately after extraction and at 4 months post extraction to plan implant placement. These images will also be used to assess changes in the dimension of the post extraction bone (primary outcome). As part of the study different questionnaires will be administered to assess quality of life and perception of the therapy and the wound exudate in the area of the extraction will be collected non invasively with a collagen sponge to assess the expression of different proteins during the early healing days. On the day of implant placement a sample of bone tissue will also be collected as part of the bone drilling and histologically analysed.
Detailed description
This is a single-centre, double-blind RCT involving 40 patients in need for a single tooth extraction to be replaced with a dental implant. The study consists of 11 visits, over a minimum period of 20 months. Participants will be recruited at Centro di Odontoiatria, at Università di Parma amongst patients routinely seen in new patient clinics and follow-up clinics. After atraumatic tooth extraction, participants will be randomly allocated to one of the following treatment groups: - DBBM (Bio-oss, Geistlich) mixed with a PNHA gel (Regenfast, Mastelli) and socket sealed with a porcine collagen matrix (Mucograft seal, Geistlich) (Test); - Unassisted socket healing (Control). Patient post-operative discomfort will be assessed with a visual analogue scale (VAS) and through clinician-reported post-operative oedema/swelling. Clinical evaluation of socket healing and recording of soft tissue healing index of Landry will also be performed during the early post-extraction days. With the help of a sterilecollagen sponge, wound exudate will be collected at 3, 7 and 14 days post extraction. A CBCT with a small field of view (e.g. 5X8 cm) will be taken to assess the post-extraction socket dimensions and after 4 months to plan implant placement. The CBCT scan will be processed with its embedded segmentation function to remove scattering defects and obtain the maximal possible quality.
Changes in alveolar ridge width from the extraction until 4 months post extraction between the 2 groups will be assessed with a dedicated software (e.g. SMOP) (primary outcome).
On the day of implant placement, a bone core biopsy will be collected from the drilling site. Undecalcified histology analysis will be done, and qualitative histology will be performed by a blind examiner, who will assess the level of maturation of the tissue in the two groups. Moreover, histomorphometric measurements will be recorded and presented descriptively, including amount of mineralized bone, as well as other standard parameters, such as %graft particles (test group only) and % of immature woven bone. A fully digital workflow will be followed to rehabilitate the patients, which will be followed up at up to 12 months post implant loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous post extraction healing | No intervention | –The control group will not receive any biomaterial in the post extraction socket |
| Alveolar ridge preservation | Experimental | Device: regeneration of post extraction socket with biomaterialsIn the group assigned to receive socket preservation, particulate deproteinizied bovine bone mineral (Bio-oss, Geistlich biomaterials) mixed with a gel containing hyaluronic acid and polynucleotides (Regenfast, Mastelli) will be placed in the socket without overfilling it and the socket will be sealed with a porcine collagen matrix (Mucograft seal, Geistlich), Any remaining PNHA gel will be placed at the entrance of the socket and on the surrounding gingival tissue |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥25-year-old males and females;
- good systemic health (self-assessment);
- presence of an unrestorable/hopeless tooth with periodontal attachment and buccal bone preserved at least for 2/3rd of the root and not associated with acute periapical pathology;
- full mouth bleeding and plaque scores ≤ 25%
Key exclusion criteria (7 listed)
- uncontrolled or untreated periodontal disease;
- history of local (head and neck) radiation therapy in the past 5 years;
- acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible);
- medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. HIV-related disease);
- history of alcohol or drug abuse;
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 |
|---|---|---|
| regeneration of post extraction socket with biomaterialsAlso: alveolar ridge preservation, socket preservationafter tooth extraction, in the test group we will place a demineralised bovine bone graft mixed with a gel containing hyaluronic acid and polynucleotide and we will cover the entrance of the socket with a collagen matrix | Device | Alveolar ridge preservation |
Primary outcome
Change in alveolar ridge width at 4 months post extraction between study groups
Time frame: 4 months after tooth extraction (visit 6)
This is a superiority outcome evaluating horizontal ridge width changes at four months post-extraction between test and contro group with the help of a CBCT scan.
12 secondary outcomes
quality of newly formed bone
Time frame: 4 months post extraction (visit 6)
3D volume changes
Time frame: 4 months post extraction (visit 6)
changes in protein expression
Time frame: 3, 7 and 14 days post extraction (Visit 3, 4, 5)
Profilometric changes
Time frame: 3, 7, 14 days and at 4 months post extraction (visit 3, 4, 5)
Change in post operative discomfort
Time frame: 3, 7 and 14 days after extraction (visit 3, 4, 5)
Change in Landry healing index
Time frame: 3, 7 and 14 days after extraction (Visit 3, 4, 5)
Changes in keratinized tissue
Time frame: 4 months post extraction (Visit 6) and at study termination 12 months post loading (Visit 10);
Qualitative assessment of post-operative need for medications
Time frame: Starting after extraction (visit 2) and until 14 days post extraction (Visit 3, 4, 5)
Possibility to prosthetically place an implant
Time frame: implant placement (Visit 7 - within 5 months from tooth extraction)
Peri-implant radiographic bone level changes
Time frame: at implant loading (visit 9 - within 5 months from implant placement) and at the end of the study (12 months post loading - visit 10)
Participants' satisfaction with treatment
Time frame: at the end of the study, 12 months post loading (Visit 10)
Implant torque
Time frame: Implant placement (visit 7 - within 5 months from tooth extraction)
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 8 Sep 2025.
- Background: PubMed 12899922Guizzardi S, Galli C, Govoni P, Boratto R, Cattarini G, Martini D, Belletti S, Scandroglio R. Polydeoxyribonucleotide (PDRN) promotes human osteoblast proliferation: a new proposal for bone tissue repair. Life Sci. 2003 Aug 29;73(15):1973-83. doi: 10.1016/s0024-3205(03)00547-2.
- Background: PubMed 33480222Colangelo MT, Govoni P, Belletti S, Squadrito F, Guizzardi S, Galli C. Polynucleotide biogel enhances tissue repair, matrix deposition and organization. J Biol Regul Homeost Agents. 2021 Jan-Feb;35(1):355-362. doi: 10.23812/20-320-L. No abstract available.
- Background: PubMed 30623987Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
- Individual participant dataSharing planned: No. All patients' data held will be coded and pseudo-anonymised with an alphanumerical code that will be kept separately from the personal data as name, surname, date and place of birth and sex and stored in a locked cabinet in the PI's office. The only people within the Centro di Odontoiatria who will have access to information that identifies the patients will be people who need to contact them about the research study, and make sure that relevant information about the study is recorded for their care, and to oversee the quality of the study or audit the data collection process. The people who analyse the information will not be able to identify patients and will not be able to find out their name or contact details.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regeneration of post extraction socket with biomaterials in people with Socket Preservation and Implant-supported Single Crowns, run by University of Parma at 2 sites 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 4 inclusion and 7 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Elena Calciolari, DDS, MS, PhD (+390521903640, elena.calciolari@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alveolar ridge width at 4 months post extraction between study groups (time frame: 4 months after tooth extraction (visit 6)). 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 NCT07099846, which also lists 3 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 8 Sep 2025.