Soft Tissue AtrophyNCT07626866
Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
A study testing Free connective tissue graft without an epithelial collar and Free connective tissue graft with epithelial collar in people with Soft Tissue Atrophy, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned. The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed. In the first group, a free connective tissue graft with an epithelial collar will be used. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Atrophy
- What is being tested?
- Free connective tissue graft without an epithelial collar and Free connective tissue graft with epithelial collar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jun 2024to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Patient refusal to continue participation in the study;
- Pregnant or breastfeeding women;
- Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
- Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
About this study
Official title: Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned. The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed. In the first group, a free connective tissue graft with an epithelial collar will be used. In the second group, a free connective tissue graft without an epithelial collar will be used. In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
Read the detailed description
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.
- Conditions
- Soft Tissue Atrophy
- Being tested
- Free connective tissue graft without an epithelial collar, Free connective tissue graft with epithelial collar
- Keywords
- Connective tissue graft, increasing of soft tissue thickness, dental implant, soft tissue augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free connective tissue graft without an epithelial collarProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol.
- Formation of the recipient site in the vestibular area.
- Harvesting of free connective tissue graft from the maxilla tuberosity area or palate and its adaptation to the recipient site.
- Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
- Suturing of the wound in the donor site.
Free connective tissue graft with epithelial collarProcedure or surgery
- Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol.
- Formation of the recipient site in the vestibular area.
- Harvesting of free connective tissue graft with epithelial strip from the maxilla tuberosity area or palate and its adaptation to the recipient site.
- Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
- Suturing of the wound in the donor site.
| Study group | Role | What they receive |
|---|---|---|
| first group | Active comparator | Patients will receive a free connective tissue graft without an epithelial collar Receives: Procedure: Free connective tissue graft without an epithelial collar |
| second group | Experimental | Patients will receive a free connective tissue graft with epithelial collar Receives: Procedure: Free connective tissue graft with epithelial collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Width of Keratinized Mucosa
Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
Measured: Day 90 compared to the 0th day (initial value)
Secondary outcomes (24)
Change in the Width of Keratinized Mucosa
Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by laboratory scanning before surgery and on postoperative day 180. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
Measured: Day 180 compared to the 0th day (initial value)
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation. Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes. The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation. Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
Measured: Day 90 compared to the 0th day (initial value)
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation. Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes. The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation. Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
Measured: Day 180 compared to the 0th day (initial value)
Assessment of Pain Severity
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
Measured: 4 hours compared to the 0th day (initial value)
Assessment of Pain Severity
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
Measured: Day 1 compared to the 0th day (initial value)
Assessment of Pain Severity
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
Measured: Day 3 compared to the 0th day (initial value)
Assessment of Pain Severity
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
Measured: Day 5 compared to the 0th day (initial value)
Assessment of Pain Severity
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
Measured: Day 7 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
Measured: Day 1 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
Measured: Day 3 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
Measured: Day 5 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
Measured: Day 7 compared to the 0th day (initial value)
Assessment of Bleeding
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
Measured: Day 1 compared to the 0th day (initial value)
Assessment of Bleeding
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
Measured: Day 3 compared to the 0th day (initial value)
Assessment of Bleeding
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
Measured: Day 5 compared to the 0th day (initial value)
Assessment of Bleeding
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
Measured: Day 7 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Measured: Day 1 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Measured: Day 3 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Measured: Day 5 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Measured: Day 7 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
Measured: Day 0 (initial value)
Quality of Life Assessment According to OHIP-14
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
Measured: Day 7 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
Measured: Day 90-93 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
Measured: Day 180-186 compared to the 0th day (initial value)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 Jun 2024
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AtrophyStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor P Ashurko, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626866
- Sponsor's protocol ID
- AI-05
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants
- ClinicalTrials.gov ID
- NCT07626866
- Acronym / sponsor ID
- AI-05
- Conditions
- Soft Tissue Atrophy
- Keywords
- Connective tissue graft, increasing of soft tissue thickness, dental implant, soft tissue augmentation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 4 Jun 2026 (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.
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned. The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed. In the first group, a free connective tissue graft with an epithelial collar will be used. In the second group, a free connective tissue graft without an epithelial collar will be used. In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
Detailed description
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | Active comparator | Procedure: Free connective tissue graft without an epithelial collarPatients will receive a free connective tissue graft without an epithelial collar |
| second group | Experimental | Procedure: Free connective tissue graft with epithelial collarPatients will receive a free connective tissue graft with epithelial collar |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patient refusal to continue participation in the study;
- Pregnant or breastfeeding women;
- Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
- Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).
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 |
|---|---|---|
| Free connective tissue graft without an epithelial collar1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol. 2. Formation of the recipient site in the vestibular area. 3. Harvesting of free connective tissue graft from the maxilla tuberosity area or palate and its adaptation to the recipient site. 4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area. 5. Suturing of the wound in the donor site. | Procedure or surgery | first group |
| Free connective tissue graft with epithelial collar1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol. 2. Formation of the recipient site in the vestibular area. 3. Harvesting of free connective tissue graft with epithelial strip from the maxilla tuberosity area or palate and its adaptation to the recipient site. 4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area. 5. Suturing of the wound in the donor site. | Procedure or surgery | second group |
Primary outcome
Change in the Width of Keratinized Mucosa
Time frame: Day 90 compared to the 0th day (initial value)
Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
24 secondary outcomes
Change in the Width of Keratinized Mucosa
Time frame: Day 180 compared to the 0th day (initial value)
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Time frame: Day 90 compared to the 0th day (initial value)
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Time frame: Day 180 compared to the 0th day (initial value)
Assessment of Pain Severity
Time frame: 4 hours compared to the 0th day (initial value)
Assessment of Pain Severity
Time frame: Day 1 compared to the 0th day (initial value)
Assessment of Pain Severity
Time frame: Day 3 compared to the 0th day (initial value)
Assessment of Pain Severity
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of Pain Severity
Time frame: Day 7 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Time frame: Day 1 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Time frame: Day 3 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Time frame: Day 7 compared to the 0th day (initial value)
Assessment of Bleeding
Time frame: Day 1 compared to the 0th day (initial value)
Assessment of Bleeding
Time frame: Day 3 compared to the 0th day (initial value)
Assessment of Bleeding
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of Bleeding
Time frame: Day 7 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Time frame: Day 1 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Time frame: Day 3 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Time frame: Day 5 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Time frame: Day 7 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Time frame: Day 0 (initial value)
Quality of Life Assessment According to OHIP-14
Time frame: Day 7 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Time frame: Day 90-93 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Time frame: Day 180-186 compared to the 0th day (initial value)
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 4 Jun 2026.
- 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. This study is not recruiting at the moment.
Igor P Ashurko principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov 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 Free connective tissue graft without an epithelial collar and Free connective tissue graft with epithelial collar in people with Soft Tissue Atrophy, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 0 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 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 Russia. 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?
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?
Change in the Width of Keratinized Mucosa (time frame: Day 90 compared to the 0th day (initial value)). 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 4 Jun 2026.