Interdental Papillae ReconstructionPhase 1/2NCT07012525
Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique
A Phase 1/2 study testing Photobiomodulation Therapy + Hyaluronic Acid Gel Injection and Hyaluronic Acid Gel Injection in people with Interdental Papillae Reconstruction, run by Dar Al Uloom University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of a minimally invasive therapy combining photobiomodulation (PBMT) with injectable dermal filler (hyaluronic acid) in adult patients (ages 20-40) with interdental papillary loss (Norland \& Tarnow Class I) in the maxillary anterior region. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Interdental Papillae Reconstruction
- What is being tested?
- Photobiomodulation Therapy + Hyaluronic Acid Gel Injection and Hyaluronic Acid Gel Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Sep 2025to 30 Dec 2026
- Phase
- Phase 1/2
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20 to 40 years
- Presence of at least two non-adjacent interdental papilla defects (Class I, Norland \& Tarnow classification) in the maxillary anterior region
- Healthy periodontal status, with:
- Probing depth ≤ 3 mm
- No gingival recession
- No tooth mobility (Score 0)
Show all 13Show fewer
- No interdental bone loss on radiographs
- Non-smokers
- No previous orthodontic treatment
- Free from gingival or dental surface alterations (e.g., abfraction, irregularities, or overcontouring)
- Systemically healthy (no systemic diseases or conditions affecting healing or immune function)
- Willing and able to comply with study procedures and follow-up visits
- Provided written informed consent after explanation of study procedures
Who cannot join
- Candidates will be excluded if they meet any of the following:
- Systemic diseases or medications known to affect soft tissue healing (e.g., diabetes, immunosuppressants)
- Pregnancy or lactation
- History of periodontal surgery in the study area
- Known allergy or hypersensitivity to hyaluronic acid or local anesthetics
- Current use of anti-inflammatory drugs, anticoagulants, or antibiotics that could affect healing
- Poor oral hygiene or non-compliance during pre-treatment phase
- Participation in another clinical trial within the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
SREIC Scientific Research Ethics and Innovative committee contact
Saudi Arabia1 site
College of Dentistry, Dar AlUloom University
Riyadh, 11512
Sally ElHaddad, Assist. Prof., 00966555361062, s.elhaddad@dau.edu.sa
About this study
The goal of this clinical trial is to evaluate the effectiveness of a minimally invasive therapy combining photobiomodulation (PBMT) with injectable dermal filler (hyaluronic acid) in adult patients (ages 20-40) with interdental papillary loss (Norland \& Tarnow Class I) in the maxillary anterior region.
The main questions it aims to answer are:
Read more
Does PBMT enhance the regenerative effect of hyaluronic acid filler in restoring the interdental papilla? Is the combined therapy superior to dermal filler alone in achieving long-term aesthetic and clinical stability?
Researchers will compare:
Group I (control) - hyaluronic acid filler alone vs. Group II (experimental) - PBMT applied before and after hyaluronic acid filler to see if PBMT contributes to better papilla height, width, and volume restoration over 12 months.
Participants will:
Undergo standard periodontal cleaning and education 4 weeks before treatment Receive local anesthesia and dermal filler injections in both quadrants (split-mouth design)
Have PBMT applied in one quadrant only (Group II) Be followed up at regular intervals (1 week to 12 months) for clinical measurements and digital image analysis of papilla dimensions This study introduces a non-surgical, patient-friendly technique that may enhance soft tissue regeneration in esthetic areas, offering a potential breakthrough in managing interdental papillary loss.
Read the detailed description
This study explores a novel, minimally invasive therapeutic approach to treating interdental papillary loss (IDP)-a condition with both functional and esthetic consequences, particularly in the maxillary anterior region. While surgical techniques for papilla regeneration have been investigated for decades, success has been limited due to anatomical challenges such as restricted blood supply and the small volume of tissue involved. Additionally, many of these procedures are invasive, complex, and do not guarantee long-term stability.
The proposed study evaluates the synergistic effect of photobiomodulation therapy (PBMT), formerly known as low-level laser therapy (LLLT), when combined with injectable hyaluronic acid (HA) dermal filler. PBMT is known to enhance microcirculation, stimulate fibroblast activity, and promote angiogenesis, all of which may contribute to improved tissue regeneration. HA, on the other hand, supports extracellular matrix remodeling, tissue hydration, and wound healing. While HA has shown some promise when used alone for papilla reconstruction, recurrence of papillary loss has been reported within 6-12 months post-treatment.
This clinical trial employs a split-mouth, randomized controlled design to compare two interventions within the same patient-HA filler alone versus HA combined with PBMT. By minimizing inter-patient variability, this design enhances internal validity and provides a more reliable comparison of treatment efficacy.
Throughout a 12-month follow-up period, the study will assess changes in papillary height, width, and overall tissue volume using standardized clinical measurements and digital imaging analysis. Additionally, the PBMT group will receive laser therapy at each follow-up session to evaluate its ongoing regenerative contribution.
This study aims to introduce a patient-friendly, conservative alternative to surgical procedures, with the potential to become a predictable and reproducible technique in the esthetic zone. If successful, it may offer a paradigm shift in managing one of the most challenging soft tissue defects in periodontal and esthetic dentistry.
- Conditions
- Interdental Papillae Reconstruction
- Being tested
- Photobiomodulation Therapy + Hyaluronic Acid Gel Injection, Hyaluronic Acid Gel Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation Therapy + Hyaluronic Acid Gel InjectionProcedure or surgery
This arm includes the test sites (e.g., left maxillary quadrant) in each participant. The same dose of hyaluronic acid (0.2 mL of 0.8% gel) will be injected in the same manner as in the control group. However, photobiomodulation therapy (PBMT) using a diode laser (wavelength 630-670 nm, 25 mW, 1.875 J/cm² for 20 seconds) will be applied before and after the injection. Laser application will be repeated at every follow-up appointment to promote tissue healing, angiogenesis, and papillary regeneration.
Hyaluronic Acid Gel InjectionDrug
This arm includes the control sites (e.g., right maxillary quadrant) in each participant. The interdental papilla with Class I deficiency will be treated using 0.2 mL of 0.8% commercial hyaluronic acid gel, injected 2-3 mm apical to the papilla tip. This is a commonly used non-surgical soft tissue filler in periodontal and esthetic procedures. No photobiomodulation therapy will be applied in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation + Hyaluronic Acid | Experimental | This arm includes the test sites (e.g., left maxillary quadrant) in each participant. The same dose of hyaluronic acid (0.2 mL of 0.8% gel) will be injected in the same manner as in the control group. However, photobiomodulation therapy (PBMT) using a diode laser (wavelength 630-670 nm, 25 mW, 1.875 J/cm² for 20 seconds) will be applied before and after the injection. Laser application will be repeated at every follow-up appointment to promote tissue healing, angiogenesis, and papillary regeneration. Receives: Procedure: Photobiomodulation Therapy + Hyaluronic Acid Gel Injection |
| Hyaluronic Acid Gel Injection only | Active comparator | This arm includes the control sites (e.g., right maxillary quadrant) in each participant. The interdental papilla with Class I deficiency will be treated using 0.2 mL of 0.8% commercial hyaluronic acid gel, injected 2-3 mm apical to the papilla tip. This is a commonly used non-surgical soft tissue filler in periodontal and esthetic procedures. No photobiomodulation therapy will be applied in this arm. Receives: Drug: Hyaluronic Acid Gel Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Papillary Deficient Area
This outcome measures the change in the total area of interdental papillary deficiency (in mm²), calculated using standardized measurements of papillary height and width. The area is estimated using the formula:
Area = ½ × Papillary Width × Papillary Deficient Height.
Method of Assessment:
Clinical measurements with a UNC-15 probe and digital photographic analysis.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcomes (5)
Change in Papillary Width
Measures the horizontal base width of the interdental papilla at the crestal level between adjacent teeth.
Assessment Tool:
Clinical probing and digital image analysis.
Measured: Baseline and follow-up at 1, 3, 6, and 12 months
Change in Papillary Deficient Height
Vertical distance (in mm) from the tip of the papilla to the contact point between adjacent teeth.
Assessment Tool:
Periodontal probe (UNC-15) and digital images.
Measured: Baseline and follow-up at 1, 3, 6, and 12 months
Digital Image Analysis Score
Quantitative assessment of papillary volume and soft tissue contour using standardized intraoral photographs and imaging software.
Measured: Baseline and follow-up at 1, 3, 6, and 12 months
Patient Satisfaction and Aesthetic Score
Patient-reported outcomes evaluating satisfaction with esthetics and comfort using a visual analog scale (VAS) from 0 to 10.
Measured: At 3, 6, and 12 months
Incidence of Adverse Effects
Monitors for soft tissue reactions, pain, inflammation, or infection at treatment sites.
Measured: throughout the study duration (from initial treatment up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdental Papillae ReconstructionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Type: Interventional (Clinical Trial) Model: Split-Mouth, Parallel Assignment Masking: Single-Blind (Outcomes Assessor) Primary Purpose: Treatment This study follows a split-mouth randomized controlled design, where each participant serves as their own control. The oral cavity is divided into right and left maxillary quadrants. One quadrant (control group) will receive hyaluronic acid (HA) filler only, while the other quadrant (experimental group) will receive HA filler combined with photobiomodulation therapy (PBMT). This within-subject model minimizes inter-individual variability and allows for more accurate comparison of treatment efficacy between the two modalities. Randomization determines which side receives the PBMT-enhanced therapy. Outcome assessors are blinded to group allocation to reduce bias during follow-up measurements.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar Al Uloom University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Abd-ElMeniem ElHaddad, Dar Al Uloom University
- Investigators
- SREIC College of dentistry, Dar AlUloom University, Study director, College of Dentistry, Dar AlUloom University, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012525
- Sponsor's protocol ID
- 31-05-2024
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic data: age, sex, and quadrant assignment (test vs. control) Papillary measurements: Papillary width Papillary deficient height Calculated deficient area (mm²) Digital image analysis scores: baseline and all follow-up intervals Patient-reported outcomes: aesthetic satisfaction scores (VAS) Adverse events: type, frequency, and severity of any reported reactions All data will be anonymized to ensure participant confidentiality in accordance with applicable ethical and legal standards.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique
- ClinicalTrials.gov ID
- NCT07012525
- Acronym / sponsor ID
- 31-05-2024
- Conditions
- Interdental Papillae Reconstruction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Dar Al Uloom UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jun 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 goal of this clinical trial is to evaluate the effectiveness of a minimally invasive therapy combining photobiomodulation (PBMT) with injectable dermal filler (hyaluronic acid) in adult patients (ages 20-40) with interdental papillary loss (Norland \& Tarnow Class I) in the maxillary anterior region.
The main questions it aims to answer are:
Does PBMT enhance the regenerative effect of hyaluronic acid filler in restoring the interdental papilla? Is the combined therapy superior to dermal filler alone in achieving long-term aesthetic and clinical stability?
Researchers will compare:
Group I (control) - hyaluronic acid filler alone vs. Group II (experimental) - PBMT applied before and after hyaluronic acid filler to see if PBMT contributes to better papilla height, width, and volume restoration over 12 months.
Participants will:
Undergo standard periodontal cleaning and education 4 weeks before treatment Receive local anesthesia and dermal filler injections in both quadrants (split-mouth design)
Have PBMT applied in one quadrant only (Group II) Be followed up at regular intervals (1 week to 12 months) for clinical measurements and digital image analysis of papilla dimensions This study introduces a non-surgical, patient-friendly technique that may enhance soft tissue regeneration in esthetic areas, offering a potential breakthrough in managing interdental papillary loss.
Detailed description
This study explores a novel, minimally invasive therapeutic approach to treating interdental papillary loss (IDP)-a condition with both functional and esthetic consequences, particularly in the maxillary anterior region. While surgical techniques for papilla regeneration have been investigated for decades, success has been limited due to anatomical challenges such as restricted blood supply and the small volume of tissue involved. Additionally, many of these procedures are invasive, complex, and do not guarantee long-term stability.
The proposed study evaluates the synergistic effect of photobiomodulation therapy (PBMT), formerly known as low-level laser therapy (LLLT), when combined with injectable hyaluronic acid (HA) dermal filler. PBMT is known to enhance microcirculation, stimulate fibroblast activity, and promote angiogenesis, all of which may contribute to improved tissue regeneration. HA, on the other hand, supports extracellular matrix remodeling, tissue hydration, and wound healing. While HA has shown some promise when used alone for papilla reconstruction, recurrence of papillary loss has been reported within 6-12 months post-treatment.
This clinical trial employs a split-mouth, randomized controlled design to compare two interventions within the same patient-HA filler alone versus HA combined with PBMT. By minimizing inter-patient variability, this design enhances internal validity and provides a more reliable comparison of treatment efficacy.
Throughout a 12-month follow-up period, the study will assess changes in papillary height, width, and overall tissue volume using standardized clinical measurements and digital imaging analysis. Additionally, the PBMT group will receive laser therapy at each follow-up session to evaluate its ongoing regenerative contribution.
This study aims to introduce a patient-friendly, conservative alternative to surgical procedures, with the potential to become a predictable and reproducible technique in the esthetic zone. If successful, it may offer a paradigm shift in managing one of the most challenging soft tissue defects in periodontal and esthetic dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Study Type: Interventional (Clinical Trial) Model: Split-Mouth, Parallel Assignment Masking: Single-Blind (Outcomes Assessor) Primary Purpose: Treatment This study follows a split-mouth randomized controlled design, where each participant serves as their own control. The oral cavity is divided into right and left maxillary quadrants. One quadrant (control group) will receive hyaluronic acid (HA) filler only, while the other quadrant (experimental group) will receive HA filler combined with photobiomodulation therapy (PBMT). This within-subject model minimizes inter-individual variability and allows for more accurate comparison of treatment efficacy between the two modalities. Randomization determines which side receives the PBMT-enhanced therapy. Outcome assessors are blinded to group allocation to reduce bias during follow-up measurements.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation + Hyaluronic Acid | Experimental | Procedure: Photobiomodulation Therapy + Hyaluronic Acid Gel InjectionThis arm includes the test sites (e.g., left maxillary quadrant) in each participant. The same dose of hyaluronic acid (0.2 mL of 0.8% gel) will be injected in the same manner as in the control group. However, photobiomodulation therapy (PBMT) using a diode laser (wavelength 630-670 nm, 25 mW, 1.875 J/cm² for 20 seconds) will be applied before and after the injection. Laser application will be repeated at every follow-up appointment to promote tissue healing, angiogenesis, and papillary regeneration. |
| Hyaluronic Acid Gel Injection only | Active comparator | Drug: Hyaluronic Acid Gel InjectionThis arm includes the control sites (e.g., right maxillary quadrant) in each participant. The interdental papilla with Class I deficiency will be treated using 0.2 mL of 0.8% commercial hyaluronic acid gel, injected 2-3 mm apical to the papilla tip. This is a commonly used non-surgical soft tissue filler in periodontal and esthetic procedures. No photobiomodulation therapy will be applied in this arm. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adults aged 20 to 40 years
- Presence of at least two non-adjacent interdental papilla defects (Class I, Norland \& Tarnow classification) in the maxillary anterior region
- Healthy periodontal status, with:
- Probing depth ≤ 3 mm
- No gingival recession
Key exclusion criteria (8 listed)
- Candidates will be excluded if they meet any of the following:
- Systemic diseases or medications known to affect soft tissue healing (e.g., diabetes, immunosuppressants)
- Pregnancy or lactation
- History of periodontal surgery in the study area
- Known allergy or hypersensitivity to hyaluronic acid or local anesthetics
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 |
|---|---|---|
| Photobiomodulation Therapy + Hyaluronic Acid Gel InjectionThis arm includes the test sites (e.g., left maxillary quadrant) in each participant. The same dose of hyaluronic acid (0.2 mL of 0.8% gel) will be injected in the same manner as in the control group. However, photobiomodulation therapy (PBMT) using a diode laser (wavelength 630-670 nm, 25 mW, 1.875 J/cm² for 20 seconds) will be applied before and after the injection. Laser application will be repeated at every follow-up appointment to promote tissue healing, angiogenesis, and papillary regeneration. | Procedure or surgery | Photobiomodulation + Hyaluronic Acid |
| Hyaluronic Acid Gel InjectionThis arm includes the control sites (e.g., right maxillary quadrant) in each participant. The interdental papilla with Class I deficiency will be treated using 0.2 mL of 0.8% commercial hyaluronic acid gel, injected 2-3 mm apical to the papilla tip. This is a commonly used non-surgical soft tissue filler in periodontal and esthetic procedures. No photobiomodulation therapy will be applied in this arm. | Drug | Hyaluronic Acid Gel Injection only |
Primary outcome
Change in Papillary Deficient Area
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
This outcome measures the change in the total area of interdental papillary deficiency (in mm²), calculated using standardized measurements of papillary height and width. The area is estimated using the formula: Area = ½ × Papillary Width × Papillary Deficient Height. Method of Assessment: Clinical measurements with a UNC-15 probe and digital photographic analysis.
5 secondary outcomes
Change in Papillary Width
Time frame: Baseline and follow-up at 1, 3, 6, and 12 months
Change in Papillary Deficient Height
Time frame: Baseline and follow-up at 1, 3, 6, and 12 months
Digital Image Analysis Score
Time frame: Baseline and follow-up at 1, 3, 6, and 12 months
Patient Satisfaction and Aesthetic Score
Time frame: At 3, 6, and 12 months
Incidence of Adverse Effects
Time frame: throughout the study duration (from initial treatment up to 12 months)
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 22 Aug 2025.
- Individual participant dataSharing planned: Yes. Demographic data: age, sex, and quadrant assignment (test vs. control) Papillary measurements: Papillary width Papillary deficient height Calculated deficient area (mm²) Digital image analysis scores: baseline and all follow-up intervals Patient-reported outcomes: aesthetic satisfaction scores (VAS) Adverse events: type, frequency, and severity of any reported reactions All data will be anonymized to ensure participant confidentiality in accordance with applicable ethical and legal standards.
Related trials for Interdental Papillae Reconstruction
Not yet recruiting
A Modern, Non-surgical Method for Treating Papillary Deficiencies is the Use of Hyaluronic Acid, Which Have Demonstrated Encouraging Outcome. Subperiosteal Hyaluronic Acid Injection Overlay Technique with the Idea of Merging Hyaluronic Acid Injection with Surgical Intervention to Reconstruct Idp
Interdental Papillae Reconstruction, Hyaluronic Acid
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.
SREIC Scientific Research Ethics and Innovative committee contact
SREIC College of dentistry, Dar AlUloom University study director
College of Dentistry, Dar AlUloom University, SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Photobiomodulation Therapy + Hyaluronic Acid Gel Injection and Hyaluronic Acid Gel Injection in people with Interdental Papillae Reconstruction, run by Dar Al Uloom University at 1 site in Saudi Arabia.
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 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sally A ElHaddad, Assist. Prof. (+966555361062, s.elhaddad@dau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Papillary Deficient Area (time frame: Baseline, 1 month, 3 months, 6 months, and 12 months). 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 22 Aug 2025.