Ridge DeficencyPINCT03763617
Periosteal Inhibition Technique for Ridge Preservation A Prospective Study
A study testing d-ptfe membrane in people with Ridge Deficency, run by Clinique Dentaire et d'implantologie Dr.Vinh Nguyen at 1 site in Canada.
Trial summary
The efficacy of the Periosteal Inhibition technique for socket preservation is studies against a control group in which the extraction sockets are allowed to heal without a socket preservation procedure. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Deficency
- What is being tested?
- d-ptfe membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 22 years of age
- Systemically healthy
- An extraction of one non-salvageable molar or premolar tooth is indicated. Adjacent teeth must be present to support the measuring template.
- Demonstrated ability to maintain goodoral hygiene
- Willingness and ability to commit to follow-up
- Able to understand study procedure and provide signed informed consent.
Who cannot join
- Extensive damaged buccal or lingual bone plate
- Extreme alveolar ridge atrophy
- Extensive vertical bone loss
- Active infection at the extraction site
- Uncontrolled periodontal disease.
- Recent febrile illness (within 6 months) that precludes or delays participation
Show all 13Show fewer
- Severe renal or liver diseases
- History of radiotherapy of the head and neck region
- Chemotherapy for treatment of malignant tumors at the time of the study.
- Immuno-compromised patients
- Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years.
- Use of disallowed concomitant medications.
- Pregnancy or intending to conceive during the course of the Study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique Dentaire et d'implantology Dr. Vinh Nguyen
Brossard, Quebec, J4W2T4
About this study
The efficacy of the Periosteal Inhibition technique for socket preservation is studies against a control group in which the extraction sockets are allowed to heal without a socket preservation procedure.
Read the detailed description
Socket preservation procedures have been shown to significantly reduce the loss of ridge dimension of an extraction socket. These procedures involve filling the empty socket with a bone graft material, which, serves as scaffold to limit horizontal and vertical ridge alterations. In order to contain the graft material, an occlusive barrier such as an autogenous soft tissue graft, resorbable or non-resorbable membrane, is often required. As yet, no one socket preservation technique has been proven superior to another, and none have proven totally effective in preserving ridge morphology. A net reduction of 1.5 mm in ridge width and 0.5 mm in ridge height is often observed after socket preservation procedures, which may necessitate additional hard or soft tissue augmentation to fully restore the ridge dimension.
In an animal histologic study in 2005, Araujo and Lindhe demonstrated that trauma and loss of periodontal ligament triggered an osteoclastic activity causing loss of bundle bone and modeling of the cortical bone plate. Osteoclasts are multi-nucleated cells that are responsible for bone resorption and are found on the outer layer of bone, beneath the periosteum. Osteoclasts are thought to be derived from pluripotent hematopoietic stem cells. When stimulated, these mononuclear precursors, the smallest of which is 9.5 microns in diameter, proliferate and attach to the bone surface to be resorbed, and only then fuse to form large mature multinucleated osteoclasts.
High-density polytetrafluoroethylene (d-ptfe) membranes have been used in socket preservation procedures as an occlusive barrier to contain the bone graft material.Polytetrafluoroethylene, a stable polymer and highly biocompatible, has a membrane porosity of less than 0.3 microns. It is impervious to bacteria and thus is recommended for a socket preservation technique, where a membrane is intentionally exposed.
In the present study, a high-density polytetrafluoroethylene (d-ptfe) membrane is placed between the periosteum and the buccal bone plate of an extraction socket where it will stay for a duration of 4 months, the time needed for the completion of bone forming within the socket. The goal of the non-resorbable d-ptfe membrane is to prevent the migration of precursor cells to the bone surface and thus their fusion to form osteoclast. The authors hypothesize that the passage of the precursor cells from the periosteum to the bone surface is inhibited by the small-diameter pores in the non-resorbable d-ptfe membrane. Osteolytic activity on the outer surface of the socket is thereby prevented as the precursor cells cannot form osteoclasts. The author coins the term "Periosteal Inhibition technique" for this socket preservation procedure.The study will compare dimension changes between extraction socket treated using the Periosteal Inhibition technique and those allowed to heal without a socket preservation procedure.
- Conditions
- Ridge Deficency
- Being tested
- d-ptfe membrane
- Keywords
- Socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-ptfe membraneDevice
Socket preservation using d-ptfe membrane to inhibit the formation of osteoclasts
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | A d-ptfe membrane will be placed between the buccal bone and periosteum of an extraction socket during a 4 months healing time before it is surgically removed. Receives: Device: d-ptfe membrane |
| Control group | No intervention | The extraction socket will be left to heal naturally without a socket preservation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge widths
Bucco-lingual ridge dimensions at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction intra-op and 4 months post-extraction, using a acrylic template for repeatable measurements.
Measured: 0 hour and 4 months
Change in Ridge widths on the buccal and lingual aspects
Buccal and lingual ridge dimension change at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction and 4 months post-extraction, using a acrylic template for repeatable measurements.
Measured: 0 hour and 4 months
Change in Ridge heights
Change in Ridge bone heights at messiah and distal interproximal, mid-buccal and mid-lingual aspects.
Measured: 0 hour and 4 months
Secondary outcomes (2)
Bone plate thickness
Marginal buccal and lingual bone plate thickness
Measured: 0 hour
Keratinized mucosa
Width of keratinized mucosa over the ridge
Measured: 0 hour and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Sep 2022
- Primary completion30 Nov 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Ridge DeficencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A d-ptfe membrane is placed between the buccal bone and periosteum of an extraction socket to prevent the precursors of the bone resorbing cells (osteoclasts) from adhering to the bone surface.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University
- Responsible party
- Principal investigator, Vinh Giap Nguyen, DDS, Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
- Investigators
- Vinh Giap Nguyen, DDS, MSc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763617
- Sponsor's protocol ID
- PI2018
- Acronym
- PI
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2018
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will made available.
Publications
Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
PubMed 22211303Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.
PubMed 27788625Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354MacBeth N, Trullenque-Eriksson A, Donos N, Mardas N. Hard and soft tissue changes following alveolar ridge preservation: a systematic review. Clin Oral Implants Res. 2017 Aug;28(8):982-1004. doi: 10.1111/clr.12911. Epub 2016 Jul 26.
PubMed 27458031Iocca O, Farcomeni A, Pardinas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104-114. doi: 10.1111/jcpe.12633. Epub 2016 Dec 5.
PubMed 27712001Willenbacher M, Al-Nawas B, Berres M, Kammerer PW, Schiegnitz E. The Effects of Alveolar Ridge Preservation: A Meta-Analysis. Clin Implant Dent Relat Res. 2016 Dec;18(6):1248-1268. doi: 10.1111/cid.12364. Epub 2015 Jul 1.
PubMed 26132885Hakeda Y, Kumegawa M. [Osteoclasts in bone metabolism]. Kaibogaku Zasshi. 1991 Aug;66(4):215-25. Japanese.
PubMed 1759556Hagenaars CE, van der Kraan AA, Kawilarang-de Haas EW, Visser JW, Nijweide PJ. Osteoclast formation from cloned pluripotent hemopoietic stem cells. Bone Miner. 1989 May;6(2):179-89. doi: 10.1016/0169-6009(89)90049-4.
PubMed 2788471Buckwalter JA, Glimcher MJ, Cooper RR, Recker R. Bone biology. I: Structure, blood supply, cells, matrix, and mineralization. Instr Course Lect. 1996;45:371-86. No abstract available.
PubMed 8727757Wagner JE, Collins D, Fuller S, Schain LR, Berson AE, Almici C, Hall MA, Chen KE, Okarma TB, Lebkowski JS. Isolation of small, primitive human hematopoietic stem cells: distribution of cell surface cytokine receptors and growth in SCID-Hu mice. Blood. 1995 Jul 15;86(2):512-23.
PubMed 7541665Baron R, Neff L, Tran Van P, Nefussi JR, Vignery A. Kinetic and cytochemical identification of osteoclast precursors and their differentiation into multinucleated osteoclasts. Am J Pathol. 1986 Feb;122(2):363-78.
PubMed 3946557Hoffmann O, Bartee BK, Beaumont C, Kasaj A, Deli G, Zafiropoulos GG. Alveolar bone preservation in extraction sockets using non-resorbable dPTFE membranes: a retrospective non-randomized study. J Periodontol. 2008 Aug;79(8):1355-69. doi: 10.1902/jop.2008.070502.
PubMed 18672984Laurito D, Cugnetto R, Lollobrigida M, Guerra F, Vestri A, Gianno F, Bosco S, Lamazza L, De Biase A. Socket Preservation with d-PTFE Membrane: Histologic Analysis of the Newly Formed Matrix at Membrane Removal. Int J Periodontics Restorative Dent. 2016 Nov/Dec;36(6):877-883. doi: 10.11607/prd.2114.
PubMed 27740650Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
PubMed 12931761
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periosteal Inhibition Technique for Ridge Preservation A Prospective Study
- ClinicalTrials.gov ID
- NCT03763617
- Acronym / sponsor ID
- PI / PI2018
- Conditions
- Ridge Deficency
- Keywords
- Socket preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinique Dentaire et d'implantologie Dr.Vinh NguyenUniversity, hospital or other
- Collaborators
- Goethe University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 4 Dec 2018 (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 efficacy of the Periosteal Inhibition technique for socket preservation is studies against a control group in which the extraction sockets are allowed to heal without a socket preservation procedure.
Detailed description
Socket preservation procedures have been shown to significantly reduce the loss of ridge dimension of an extraction socket. These procedures involve filling the empty socket with a bone graft material, which, serves as scaffold to limit horizontal and vertical ridge alterations. In order to contain the graft material, an occlusive barrier such as an autogenous soft tissue graft, resorbable or non-resorbable membrane, is often required. As yet, no one socket preservation technique has been proven superior to another, and none have proven totally effective in preserving ridge morphology. A net reduction of 1.5 mm in ridge width and 0.5 mm in ridge height is often observed after socket preservation procedures, which may necessitate additional hard or soft tissue augmentation to fully restore the ridge dimension.
In an animal histologic study in 2005, Araujo and Lindhe demonstrated that trauma and loss of periodontal ligament triggered an osteoclastic activity causing loss of bundle bone and modeling of the cortical bone plate. Osteoclasts are multi-nucleated cells that are responsible for bone resorption and are found on the outer layer of bone, beneath the periosteum. Osteoclasts are thought to be derived from pluripotent hematopoietic stem cells. When stimulated, these mononuclear precursors, the smallest of which is 9.5 microns in diameter, proliferate and attach to the bone surface to be resorbed, and only then fuse to form large mature multinucleated osteoclasts.
High-density polytetrafluoroethylene (d-ptfe) membranes have been used in socket preservation procedures as an occlusive barrier to contain the bone graft material.Polytetrafluoroethylene, a stable polymer and highly biocompatible, has a membrane porosity of less than 0.3 microns. It is impervious to bacteria and thus is recommended for a socket preservation technique, where a membrane is intentionally exposed.
In the present study, a high-density polytetrafluoroethylene (d-ptfe) membrane is placed between the periosteum and the buccal bone plate of an extraction socket where it will stay for a duration of 4 months, the time needed for the completion of bone forming within the socket. The goal of the non-resorbable d-ptfe membrane is to prevent the migration of precursor cells to the bone surface and thus their fusion to form osteoclast. The authors hypothesize that the passage of the precursor cells from the periosteum to the bone surface is inhibited by the small-diameter pores in the non-resorbable d-ptfe membrane. Osteolytic activity on the outer surface of the socket is thereby prevented as the precursor cells cannot form osteoclasts. The author coins the term "Periosteal Inhibition technique" for this socket preservation procedure.The study will compare dimension changes between extraction socket treated using the Periosteal Inhibition technique and those allowed to heal without a socket preservation procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A d-ptfe membrane is placed between the buccal bone and periosteum of an extraction socket to prevent the precursors of the bone resorbing cells (osteoclasts) from adhering to the bone surface.
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Device: d-ptfe membraneA d-ptfe membrane will be placed between the buccal bone and periosteum of an extraction socket during a 4 months healing time before it is surgically removed. |
| Control group | No intervention | –The extraction socket will be left to heal naturally without a socket preservation intervention. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 22 years of age
- Systemically healthy
- An extraction of one non-salvageable molar or premolar tooth is indicated. Adjacent teeth must be present to support the measuring template.
- Demonstrated ability to maintain goodoral hygiene
- Willingness and ability to commit to follow-up
Key exclusion criteria (13 listed)
- Extensive damaged buccal or lingual bone plate
- Extreme alveolar ridge atrophy
- Extensive vertical bone loss
- Active infection at the extraction site
- Uncontrolled periodontal disease.
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 |
|---|---|---|
| d-ptfe membraneSocket preservation using d-ptfe membrane to inhibit the formation of osteoclasts | Device | Test group |
Primary outcome
Ridge widths
Time frame: 0 hour and 4 months
Bucco-lingual ridge dimensions at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction intra-op and 4 months post-extraction, using a acrylic template for repeatable measurements.
Change in Ridge widths on the buccal and lingual aspects
Time frame: 0 hour and 4 months
Buccal and lingual ridge dimension change at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction and 4 months post-extraction, using a acrylic template for repeatable measurements.
Change in Ridge heights
Time frame: 0 hour and 4 months
Change in Ridge bone heights at messiah and distal interproximal, mid-buccal and mid-lingual aspects.
2 secondary outcomes
Bone plate thickness
Time frame: 0 hour
Keratinized mucosa
Time frame: 0 hour and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- Background: PubMed 22211303Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
- Background: PubMed 27788625Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.
- Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Background: PubMed 27458031MacBeth N, Trullenque-Eriksson A, Donos N, Mardas N. Hard and soft tissue changes following alveolar ridge preservation: a systematic review. Clin Oral Implants Res. 2017 Aug;28(8):982-1004. doi: 10.1111/clr.12911. Epub 2016 Jul 26.
- Background: PubMed 27712001Iocca O, Farcomeni A, Pardinas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104-114. doi: 10.1111/jcpe.12633. Epub 2016 Dec 5.
- Background: PubMed 26132885Willenbacher M, Al-Nawas B, Berres M, Kammerer PW, Schiegnitz E. The Effects of Alveolar Ridge Preservation: A Meta-Analysis. Clin Implant Dent Relat Res. 2016 Dec;18(6):1248-1268. doi: 10.1111/cid.12364. Epub 2015 Jul 1.
- Background: PubMed 1759556Hakeda Y, Kumegawa M. [Osteoclasts in bone metabolism]. Kaibogaku Zasshi. 1991 Aug;66(4):215-25. Japanese.
- Background: PubMed 2788471Hagenaars CE, van der Kraan AA, Kawilarang-de Haas EW, Visser JW, Nijweide PJ. Osteoclast formation from cloned pluripotent hemopoietic stem cells. Bone Miner. 1989 May;6(2):179-89. doi: 10.1016/0169-6009(89)90049-4.
- Background: PubMed 8727757Buckwalter JA, Glimcher MJ, Cooper RR, Recker R. Bone biology. I: Structure, blood supply, cells, matrix, and mineralization. Instr Course Lect. 1996;45:371-86. No abstract available.
- Background: PubMed 7541665Wagner JE, Collins D, Fuller S, Schain LR, Berson AE, Almici C, Hall MA, Chen KE, Okarma TB, Lebkowski JS. Isolation of small, primitive human hematopoietic stem cells: distribution of cell surface cytokine receptors and growth in SCID-Hu mice. Blood. 1995 Jul 15;86(2):512-23.
- Background: PubMed 3946557Baron R, Neff L, Tran Van P, Nefussi JR, Vignery A. Kinetic and cytochemical identification of osteoclast precursors and their differentiation into multinucleated osteoclasts. Am J Pathol. 1986 Feb;122(2):363-78.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will made available.
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.
Vinh Giap Nguyen, DDS, MSc principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing d-ptfe membrane in people with Ridge Deficency, run by Clinique Dentaire et d'implantologie Dr.Vinh Nguyen at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ridge widths (time frame: 0 hour and 4 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?
On the ClinicalTrials.gov record for NCT03763617, which also lists 27 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 18 Mar 2026.