Dental CariesNCT07231237
Clinical Study Evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure
A study testing Vitrebond™ Pulp Protect Liner/Base in people with Dental Caries and Pulp Exposure, Dental, run by Solventum US LLC at 1 site in United States.
Trial summary
This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping (DPC) on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. Read more about this study
- Who is it for?
- Ages 7 to 89 years
- Conditions the study is for
- Dental Caries, Pulp Exposure, Dental, Tooth Decay
- What is being tested?
- Vitrebond™ Pulp Protect Liner/Base
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2026to 15 Apr 2026
- 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 7 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is age 7 years or older at time of consent.
- Subject is in good general health (i.e., meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
- Subject or Subject's Legally Authorized Representative is able and willing to understand and sign an Informed Consent Form or give Assent, as applicable.
- Subject is able and willing to return in-person for all scheduled study visits.
- Subject is able and willing to follow study restrictions.
- Subject has existing dental radiographic images of the study teeth of current and acceptable diagnostic quality taken within 3 months of tooth restoration.
Show all 14Show fewer
- Study tooth has healthy periodontal tissues or mildly inflamed tissues not associated with trauma, with probing depths no greater than 4 mm and no gingival recession associated with self-reported sensitivity.
- Study tooth has no pre-operative sensitivity or exhibit pre-operative sensitivity that is relieved immediately after stimulus removal.
- Study tooth has a positive response to a sensibility test (i.e., cold test using a refrigerant spray).
- Study tooth can be restored with a direct permanent restoration (stepwise caries removal will not be used).
- Study teeth are on opposite right/left sides of the mouth (for Subjects with more than one candidate study tooth).
- Study tooth will be restored no later than 1 month after the date of the first study tooth's restoration (for Subjects with more than one candidate study tooth).
- Intra-operative Inclusion Criteria:
- Subject has one or more permanent teeth with pinpoint pulpal exposure (0.5 mm - 1.0 mm in diameter) needing direct pulp capping, excluding third molars.
Who cannot join
- Subject has a history of adverse reaction to any materials used in this study, including but not limited to acrylates.
- Subject is unable, for any reason, to tolerate the study procedures (e.g., use of a rubber dam) or the length of time required to complete the restoration(s) on the study tooth/teeth.
- Subject is taking part in or planning to be enrolled in a clinical evaluation of any other dental materials at any time during the study.
- Subject has a history of chronic use of anti-inflammatory, analgesic (pain), and/or mind-altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter perception of pain.
- Subject is pregnant or breast feeding at the time of screening.
- Subject has any spontaneous or other orofacial pain (excluding pain from trauma cases, which may exhibit spontaneous pain due to tooth fracture) within the same quadrant as the study tooth that may interfere with assessment of sensitivity.
Show all 16Show fewer
- Study tooth diagnosed with cracked tooth syndrome.
- Study tooth mobility >= grade 2 using the Miller's tooth mobility index.
- Study tooth has previous and current signs and symptoms of pulpal and/or periapical disease (e.g., root resorption or pulpal calcifications) or irreversible pulpitis (excluding pain from trauma cases).
- Study tooth has no systemic mineralization pathology (e.g., amelogenesis imperfecta, enamel hypoplasia, etc.)
- Study tooth that is not restorable
- Study tooth that requires a crown preparation.
- Subject is, in the opinion of the Investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.
- Study tooth has an existing restoration or requires a new restoration that interferes with radiographic assessments (e.g., caries on the buccal surface).
- Intra-operative Exclusion Criteria:
- Study tooth exhibits bleeding of the exposed pulp that does not stop within 8 minutes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-site, Single-Arm Clinical Study Evaluating the Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure Due to Trauma, Deep Caries, or Mechanical Etiology Under Dental Restorations
This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping (DPC) on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep teeth healthy. The DPC procedure is done by dentists to help preserve tooth health if there is pulp exposure during the tooth restoration or due to trauma. Participants must have at least one permanent tooth with pulp exposure that needs DPC to be eligible for the study.
Read the detailed description
This is a multi-site, single-arm, prospective clinical study evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base treatment for direct pulp capping on permanent teeth. Vitrebond™ Pulp Protect Liner/Base is a new product designed to be placed under dental fillings that can be used as a "Liner/Base" to create a lining between the tooth and the filling to reduce sensitivity, and for direct pulp capping if there is a small amount of dental pulp exposed during the restoration.
The purpose of this clinical study will be to assess the effectiveness and safety of Vitrebond™ Pulp Protect for direct pulp capping on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. The primary objective is to evaluate Vitrebond™ Pulp Protect Liner/Base in maintaining pulp vitality (a measure of tooth health) when used for pulp capping, measured at 1-year post-restoration. The secondary objective of this study is to evaluate treated teeth for abnormal clinical signs or symptoms for up to 5 years after treatment to assess long-term safety and effectiveness. The success of Vitrebond™ Pulp Protect for direct pulp capping in this single-arm clinical study will be determined based on an assessment of pulp vitality one year after restoration compared to a pre-specified performance goal derived from literature using calcium hydroxide as the reference comparator.
- Conditions
- Dental Caries, Pulp Exposure, Dental, Tooth Decay, Dental Decay
- Being tested
- Vitrebond™ Pulp Protect Liner/Base
- Keywords
- dental, caries, cavities, pulp exposure, direct pulp capping, Vitrebond Pulp Protect, pulp vitality, dentin bridge, pulp protection
- Medical subject headings
- Dental Caries, Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrebond™ Pulp Protect Liner/BaseDevice
Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping
| Study group | Role | What they receive |
|---|---|---|
| Vitrebond™ Pulp Protect Liner/Base | Experimental | Vitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping Receives: Device: Vitrebond™ Pulp Protect Liner/Base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp Vitality at 1-year
Pulp vitality, assessed by pulp sensibility testing using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test is indicative of the pulp vitality of the tooth (primary endpoint).
Categories for pulp vitality will include:
- Vital pulp (normal): Positive response from the pulp sensibility test that subsides within 5 seconds.
- Reversible pulpitis: Positive response from pulp sensibility test that lasts greater than 5 seconds up to approximately 30 seconds.
- Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than approximately 30 seconds.
- Non-vital pulp: Negative response from the pulp sensibility test.
Measured: 1 year post-restoration
Secondary outcomes (8)
Pulp Vitality at baseline, 3 months, 6 months, and 2, 3, 4, and 5 years
Pulp vitality, assessed by pulp sensibility testing using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test is indicative of the pulp vitality of the tooth (primary endpoint).
Categories for pulp vitality will include:
- Vital pulp (normal): Positive response from the pulp sensibility test that subsides within 5 seconds.
- Reversible pulpitis: Positive response from pulp sensibility test that lasts greater than 5 seconds up to approximately 30 seconds.
- Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than approximately 30 seconds.
- Non-vital pulp: Negative response from the pulp sensibility test.
Measured: Baseline, 3 months, 6 months, and 2, 3, 4, and 5 years post-restoration.
Reparative dentin formation
Signs of reparative dentin formation assessed by bitewing (for posterior teeth) or periapical (for anterior teeth) radiographs taken at scheduled follow-up visits. Reparative dentin formation is desired.
Categories for reparative dentin formation will include:
- Presence of reparative dentin formation
- Absence of reparative dentin formation
Measured: 6 months and 1 year, and only if taken at the 2-, 3-, 4-, and 5-year post-restoration
Apical periodontitis
Apical periodontitis will be assessed by the clinician based on clinical assessments of symptoms (percussion of teeth, palpation of nearby bone, and visual examination of tissues) as well as periapical radiographs taken at scheduled follow-up visits. Absence of apical periodontitis is desired.
Categories for apical periodontitis (symptomatic and/or asymptomatic) formation will include:
- Presence of apical periodontitis
- Absence of apical periodontitis
Measured: 6-months and 1-year post-restoration, and at 2-, 3-, 4-, and 5-years post-restoration if periapical radiographs are taken
Internal root resorption
Internal root resorption will be assessed by periapical radiographs taken at each scheduled follow-up visit at 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-year follow-up visits and any unscheduled visits involving study teeth. Absence of internal root resorption is desired.
Categories for internal root resorption will include:
- Presence of internal root resorption
- Absence of internal root resorption
Measured: 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration
External root resorption
External root resorption will be assessed by periapical radiographs taken at each scheduled follow-up visit at 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-year follow-up visits and any unscheduled visits involving study teeth. Absence of external root resorption is desired.
Categories for external root resorption will include:
- Presence of external root resorptions
- Absence of external root resorptions
Measured: 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration
Pulp canal obliteration
Pulp canal obliteration will be assessed by periapical radiographs taken at each scheduled follow-up visit at 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-year follow-up visits and any unscheduled visits involving study teeth. Absence of pulp canal obliteration is desired.
Categories for pulp canal obliteration will include:
- Presence of pulp canal obliteration
- Absence of pulp canal obliteration
Measured: 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration
Pathological tooth mobility
Pathological tooth mobility will be assessed by clinicians at scheduled visits. The American Academy of Periodontology definition of tooth mobility is the movement of a tooth in its socket resulting from an applied force.
Categories for pathological tooth mobility using the Miller's tooth mobility index will include:
- Class 0: normal (physiologic) movement when force is applied
- Class 1: < 1 mm (horizontal)
- mobility greater than physiologic
- Class 2: ≥1 mm (horizontal),
- tooth can be moved 1 mm or more in a lateral direction (buccolingual or mesiodistal); and
- inability to depress the tooth in a vertical direction (apicocoronal)
- Class 3: ≥1 mm (horizontal and vertical)
- tooth can be moved 1 mm or more in a lateral direction (buccolingual or mesiodistal); and
- ability to depress the tooth in a vertical direction (apicocoronal)
Measured: baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration
Spontaneous pain
Spontaneous pain not due to a stimulus will be self-assessed by subjects for each study tooth at scheduled visits. The baseline spontaneous pain assessment should be conducted a minimum of 3 hours after completing the restoration to allow time for the anesthesia to wear off. The baseline assessment may be conducted via phone to ask the subject if they are experiencing any spontaneous pain in the study tooth and must be completed within 1 week of the tooth restoration. The absence of spontaneous pain is desired.
Spontaneous pain is defined as prolonged intense pain that doesn't respond to over-the-counter pain medication, and/or pain that wakes you up from sleep.
Categories for spontaneous pain will include:
- Presence of spontaneous pain
- Absence of spontaneous pain
Measured: baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start17 Feb 2026
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Why it stopped: The study was terminated early due to a business decision by the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-site, single arm clinical study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mabi Singh, DMD, BDS, MS, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231237
- Sponsor's protocol ID
- EM-11-050086
- Status last verified
- May 2026
- First submitted
- 13 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Miller, S.C, Textbook of periodontia, Blakiston Company, Philidelphia, 1938
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Single-Arm Clinical Study Evaluating the Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure Due to Trauma, Deep Caries, or Mechanical Etiology Under Dental Restorations
- ClinicalTrials.gov ID
- NCT07231237
- Acronym / sponsor ID
- EM-11-050086
- Conditions
- Dental Caries, Pulp Exposure, Dental, Tooth Decay, Dental Decay
- Keywords
- dental, caries, cavities, pulp exposure, direct pulp capping, Vitrebond Pulp Protect, pulp vitality, dentin bridge
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to a business decision by the sponsor.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 17 Nov 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.
This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping (DPC) on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep teeth healthy. The DPC procedure is done by dentists to help preserve tooth health if there is pulp exposure during the tooth restoration or due to trauma. Participants must have at least one permanent tooth with pulp exposure that needs DPC to be eligible for the study.
Detailed description
This is a multi-site, single-arm, prospective clinical study evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base treatment for direct pulp capping on permanent teeth. Vitrebond™ Pulp Protect Liner/Base is a new product designed to be placed under dental fillings that can be used as a "Liner/Base" to create a lining between the tooth and the filling to reduce sensitivity, and for direct pulp capping if there is a small amount of dental pulp exposed during the restoration.
The purpose of this clinical study will be to assess the effectiveness and safety of Vitrebond™ Pulp Protect for direct pulp capping on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. The primary objective is to evaluate Vitrebond™ Pulp Protect Liner/Base in maintaining pulp vitality (a measure of tooth health) when used for pulp capping, measured at 1-year post-restoration. The secondary objective of this study is to evaluate treated teeth for abnormal clinical signs or symptoms for up to 5 years after treatment to assess long-term safety and effectiveness. The success of Vitrebond™ Pulp Protect for direct pulp capping in this single-arm clinical study will be determined based on an assessment of pulp vitality one year after restoration compared to a pre-specified performance goal derived from literature using calcium hydroxide as the reference comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-site, single arm clinical study
| Arm | Type | Receives |
|---|---|---|
| Vitrebond™ Pulp Protect Liner/Base | Experimental | Device: Vitrebond™ Pulp Protect Liner/BaseVitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping |
Who may qualify
- Ages
- 7 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Subject is age 7 years or older at time of consent.
- Subject is in good general health (i.e., meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
- Subject or Subject's Legally Authorized Representative is able and willing to understand and sign an Informed Consent Form or give Assent, as applicable.
- Subject is able and willing to return in-person for all scheduled study visits.
- Subject is able and willing to follow study restrictions.
Key exclusion criteria (16 listed)
- Subject has a history of adverse reaction to any materials used in this study, including but not limited to acrylates.
- Subject is unable, for any reason, to tolerate the study procedures (e.g., use of a rubber dam) or the length of time required to complete the restoration(s) on the study tooth/teeth.
- Subject is taking part in or planning to be enrolled in a clinical evaluation of any other dental materials at any time during the study.
- Subject has a history of chronic use of anti-inflammatory, analgesic (pain), and/or mind-altering drugs for medical (including psychiatric) and pharmacotherapeutic therapies that might alter perception of pain.
- Subject is pregnant or breast feeding at the time of screening.
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 |
|---|---|---|
| Vitrebond™ Pulp Protect Liner/BaseVitrebond™ Pulp Protect Liner/Base used for Direct Pulp Capping | Device | Vitrebond™ Pulp Protect Liner/Base |
Primary outcome
Pulp Vitality at 1-year
Time frame: 1 year post-restoration
Pulp vitality, assessed by pulp sensibility testing using a refrigerant spray intended for dental use. A positive response from the pulp sensibility test is indicative of the pulp vitality of the tooth (primary endpoint). Categories for pulp vitality will include: 1. Vital pulp (normal): Positive response from the pulp sensibility test that subsides within 5 seconds. 2. Reversible pulpitis: Positive response from pulp sensibility test that lasts greater than 5 seconds up to approximately 30 seconds. 3. Irreversible pulpitis: Prolonged positive response from pulp sensibility test that lasts more than approximately 30 seconds. 4. Non-vital pulp: Negative response from the pulp sensibility test.
8 secondary outcomes
Pulp Vitality at baseline, 3 months, 6 months, and 2, 3, 4, and 5 years
Time frame: Baseline, 3 months, 6 months, and 2, 3, 4, and 5 years post-restoration.
Reparative dentin formation
Time frame: 6 months and 1 year, and only if taken at the 2-, 3-, 4-, and 5-year post-restoration
Apical periodontitis
Time frame: 6-months and 1-year post-restoration, and at 2-, 3-, 4-, and 5-years post-restoration if periapical radiographs are taken
Internal root resorption
Time frame: 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration
External root resorption
Time frame: 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration
Pulp canal obliteration
Time frame: 6 months and 1 year, and if taken at the 2-, 3-, 4-, and 5-years post-restoration
Pathological tooth mobility
Time frame: baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration
Spontaneous pain
Time frame: baseline, 3 months, 6 months, and 1, 2, 3, 4, and 5 years post-restoration
Results and safety
The study was stopped early (reason given: The study was terminated early due to a business decision by the sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- BackgroundMiller, S.C, Textbook of periodontia, Blakiston Company, Philidelphia, 1938
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
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.
Mabi Singh, DMD, BDS, MS principal investigator
Tufts 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 Vitrebond™ Pulp Protect Liner/Base in people with Dental Caries and Pulp Exposure, Dental, run by Solventum US LLC at 1 site in United States.
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 14 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 May 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 United States. 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 was stopped early (reason given: The study was terminated early due to a business decision by the sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp Vitality at 1-year (time frame: 1 year post-restoration). 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 NCT07231237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.