ObesityNCT07731412
Short-Term Changes in Salivary IL-6, TNF-α, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients With Obesity: A Randomized Controlled Pilot Study
A study testing Laparoscopic Sleeve Gastrectomy, Non-Surgical Obesity Management and Standardized Oral-Hygiene Instructions in people with Obesity and Periodontitis, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 1 site in Romania.
Trial summary
Obesity and periodontitis are chronic inflammatory conditions that may share biological pathways. This pilot randomized controlled study compared adults with obesity and stage I-III periodontitis assigned to laparoscopic sleeve gastrectomy or non-surgical management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Periodontitis
- What is being tested?
- Laparoscopic Sleeve Gastrectomy, Non-Surgical Obesity Management and Standardized Oral-Hygiene Instructions
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteRomania
- Study dates
- 1 Dec 2022to 30 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Body mass index (BMI) ≥35 kg/m² with one or more obesity-related comorbidities, or BMI ≥40 kg/m².
- Stage I-III periodontitis according to the 2018 periodontitis stage/grade classification.
- At least 12 natural teeth in each dental arch.
- Written informed consent provided before enrollment.
Who cannot join
- • Smoking more than 10 cigarettes per day.
- Periodontal treatment within the previous 6 months.
- Pregnancy or lactation.
- Previous bariatric surgery.
- Active autoimmune disorder, malignant disease, or another systemic disease known to markedly affect periodontal inflammation.
- Recent antibiotic use
Show all 9Show fewer
- Recent systemic corticosteroid use
- Regular non-steroidal anti-inflammatory drug use within 90 days before enrollment.
- Current anti-obesity glucagon-like peptide-1 (GLP-1) therapy.
Trial locations and contacts
1 site in 1 country.
Romania1 site
George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
Târgu Mureş, 540136
About this study
Obesity and periodontitis are chronic inflammatory conditions that may share biological pathways. This pilot randomized controlled study compared adults with obesity and stage I-III periodontitis assigned to laparoscopic sleeve gastrectomy or non-surgical management. Participants underwent body measurements, a full-mouth periodontal examination, and unstimulated saliva collection at baseline, 3 months, and 6 months. Salivary interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) were measured by enzyme-linked immunosorbent assay. The primary outcomes were changes in salivary IL-6 and TNF-α. Secondary outcomes included changes in plaque index, bleeding on probing, probing pocket depth, and clinical attachment level. Body weight and body mass index were measured as contextual outcomes, and exploratory analyses examined associations between cytokine and periodontal changes. The pilot was intended to test feasibility, refine measurement procedures, and estimate preliminary effect sizes for a future definitive trial.
Read the detailed description
This randomized, controlled, prospective, longitudinal pilot study used two parallel groups. Adults aged 18-65 years with severe obesity and stage I-III periodontitis were enrolled at the 2nd Department of Surgery at the Emergency County Clinical Hospital of Targu Mures, Romania, and associated private practices. After eligibility confirmation, baseline full-mouth periodontal examination, anthropometric assessment, and unstimulated saliva collection, participants were randomly assigned to laparoscopic sleeve gastrectomy (SG) or non-surgical management (NSG). The allocation sequence was generated using a computer-based random-number procedure by an investigator who was not involved in periodontal examination or laboratory analysis. Assignments were placed in sequentially numbered, opaque, sealed envelopes and opened after completion of baseline measurements. Randomization was simple and used no blocking or stratification. Participants and treating clinicians were not blinded.
Assessments occurred at baseline, 3 months, and 6 months. Baseline was the preoperative visit for SG participants and the enrollment visit for NSG participants. Weight and height were measured, and body mass index was calculated. A single calibrated examiner performed full-mouth periodontal examinations at six sites per tooth, excluding third molars. Measures included plaque index, probing pocket depth, clinical attachment level, and bleeding on probing. Unstimulated whole saliva was collected by passive drooling between 08:00 and 10:00 after at least 2 hours without eating, drinking, smoking, toothbrushing, or mouthrinse use. Samples were centrifuged, aliquoted, stored at -80 °C, and analyzed in duplicate for salivary IL-6 and TNF-α using commercial ELISA kits. All participants received standardized oral-hygiene instructions at baseline and were advised to maintain their usual oral care. No periodontal treatment was provided during follow-up unless clinically necessary.
The primary outcomes were longitudinal changes in salivary IL-6 and TNF-α, with the principal comparison from baseline to 6 months. Secondary outcomes were longitudinal changes in plaque index, bleeding on probing, probing pocket depth, and clinical attachment level. Body weight and body mass index were contextual outcomes. Exploratory analyses examined associations between cytokine and periodontal measures. The study was designed as a pilot to assess feasibility, refine procedures, and estimate preliminary effect sizes rather than establish definitive efficacy. A formal efficacy sample-size calculation was not performed; the target sample was based on recruitment feasibility, surgical scheduling capacity, ability to complete repeated periodontal and saliva visits, and available time and funding.
- Conditions
- Obesity, Periodontitis
- Being tested
- Laparoscopic Sleeve Gastrectomy, Non-Surgical Obesity Management, Standardized Oral-Hygiene Instructions
- Keywords
- Bariatric Surgery, Sleeve Gastrectomy, Interleukin-6, Tumor Necrosis Factor-alpha, Periodontal Inflammation, Plaque Index, Bleeding on Probing
- Medical subject headings
- Obesity, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Participants randomized to the SG arm underwent laparoscopic sleeve gastrectomy as their obesity treatment.
Non-Surgical Obesity ManagementOther
conservative management
Standardized Oral-Hygiene InstructionsBehavioural
All participants received standardized oral-hygiene instructions at baseline and were advised to maintain their usual oral-care habits throughout follow-up. No periodontal treatment was provided during follow-up unless clinically necessary
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Gastrectomy Group (SG) | Experimental | Participants allocated to SG underwent laparoscopic sleeve gastrectomy and completed anthropometric, periodontal, and saliva assessments at baseline, 3 months, and 6 months. They also received standardized oral-hygiene instructions at baseline; no periodontal treatment was provided during follow-up unless clinically necessary. Receives: Procedure: Laparoscopic Sleeve Gastrectomy; Other: Non-Surgical Obesity Management; Behavioral: Standardized Oral-Hygiene Instructions |
| Non-Surgical Management Group (NSG) | Active comparator | Participants allocated to NSG received non-surgical management over the same follow-up period and completed anthropometric, periodontal, and saliva assessments at baseline, 3 months, and 6 months. They also received standardized oral-hygiene instructions at baseline; no periodontal treatment was provided during follow-up unless clinically necessary Receives: Procedure: Laparoscopic Sleeve Gastrectomy; Other: Non-Surgical Obesity Management; Behavioral: Standardized Oral-Hygiene Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in salivary interleukin-6 (IL-6) concentration at 3 and 6 months
Unstimulated whole saliva is collected by passive drooling for 5 minutes between 08:00 and 10:00 after at least 2 hours without eating, drinking, smoking, toothbrushing, or mouthrinse use. Samples are centrifuged at 3000 rpm for 10 minutes at 4 °C, aliquoted, and stored at -80 °C. IL-6 is measured with a commercial ELISA kit in duplicate; the duplicate mean is reported in pg/mL. The outcome is the within-participant change from baseline at each follow-up, with the principal endpoint at 6 months.
Measured: Baseline, 3 months, and 6 months
Change from baseline in salivary tumor necrosis factor-alpha (TNF-α) concentration at 3 and 6 months
Unstimulated whole saliva is collected and processed under the same standardized conditions as for IL-6. TNF-α is measured with a commercial ELISA kit in duplicate; the duplicate mean is reported in pg/mL. The outcome is the within-participant change from baseline at each follow-up, with the principal endpoint at 6 months
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (4)
Change from baseline in full-mouth Plaque Index at 3 and 6 months
Plaque Index is calculated as the percentage of examined tooth surfaces with visible plaque during a full-mouth examination. Higher percentages indicate more visible plaque. The outcome is the within-participant change from baseline at each follow-up
Measured: Baseline, 3 months, and 6 months
Change from baseline in bleeding on probing at 3 and 6 months
Bleeding on probing is recorded as present or absent within 15 seconds after probing at six sites per tooth, excluding third molars. The participant-level outcome is the percentage of examined sites that are BOP-positive. The outcome is the within-participant change from baseline at each follow-up.
Measured: Baseline, 3 months, and 6 months
Change from baseline in full-mouth mean probing pocket depth at 3 and 6 months
Probing pocket depth is measured in millimeters from the gingival margin to the base of the periodontal pocket at six sites per tooth, excluding third molars. The participant-level outcome is the full-mouth mean PPD in millimeters. The outcome is the within-participant change from baseline at each follow-up
Measured: Baseline, 3 months, and 6 months
Change from baseline in full-mouth mean clinical attachment level at 3 and 6 months
Clinical attachment level is measured in millimeters from the cemento-enamel junction to the base of the periodontal pocket at six sites per tooth, excluding third molars. The participant-level outcome is the full-mouth mean CAL in millimeters. The outcome is the within-participant change from baseline at each follow-up
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Dec 2022
- Primary completion15 Apr 2025
- Study completion30 Dec 2025
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 ObesityStudies 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
- Model description
- Participants were randomly assigned to laparoscopic sleeve gastrectomy or non-surgical management. Simple computer-generated randomization was used without blocking or stratification. The unequal 18/14 allocation arose by chance in the small pilot sample; no post-allocation rebalancing was performed.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felicia Gabriela Beresescu, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731412
- Sponsor's protocol ID
- No.1863/15.09.2022
- Other IDs
- Research Grant Number 511/2/17
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beresescu FG, Monea A, Ormenisan A, Tegla C, Cosarca A, Voidazan S. Short-Term Changes in Salivary IL-6, TNF-alpha, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients with Obesity: A Randomized Controlled Pilot Study. Biomedicines. 2026 Aug 4;14(8):1759. doi: 10.3390/biomedicines14081759.
PubMed 42652142
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Changes in Salivary IL-6, TNF-α, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients With Obesity: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07731412
- Acronym / sponsor ID
- No.1863/15.09.2022
- Conditions
- Obesity, Periodontitis
- Keywords
- Bariatric Surgery, Sleeve Gastrectomy, Interleukin-6, Tumor Necrosis Factor-alpha, Periodontal Inflammation, Plaque Index, Bleeding on Probing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 28 Jul 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.
Obesity and periodontitis are chronic inflammatory conditions that may share biological pathways. This pilot randomized controlled study compared adults with obesity and stage I-III periodontitis assigned to laparoscopic sleeve gastrectomy or non-surgical management. Participants underwent body measurements, a full-mouth periodontal examination, and unstimulated saliva collection at baseline, 3 months, and 6 months. Salivary interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) were measured by enzyme-linked immunosorbent assay. The primary outcomes were changes in salivary IL-6 and TNF-α. Secondary outcomes included changes in plaque index, bleeding on probing, probing pocket depth, and clinical attachment level. Body weight and body mass index were measured as contextual outcomes, and exploratory analyses examined associations between cytokine and periodontal changes. The pilot was intended to test feasibility, refine measurement procedures, and estimate preliminary effect sizes for a future definitive trial.
Detailed description
This randomized, controlled, prospective, longitudinal pilot study used two parallel groups. Adults aged 18-65 years with severe obesity and stage I-III periodontitis were enrolled at the 2nd Department of Surgery at the Emergency County Clinical Hospital of Targu Mures, Romania, and associated private practices. After eligibility confirmation, baseline full-mouth periodontal examination, anthropometric assessment, and unstimulated saliva collection, participants were randomly assigned to laparoscopic sleeve gastrectomy (SG) or non-surgical management (NSG). The allocation sequence was generated using a computer-based random-number procedure by an investigator who was not involved in periodontal examination or laboratory analysis. Assignments were placed in sequentially numbered, opaque, sealed envelopes and opened after completion of baseline measurements. Randomization was simple and used no blocking or stratification. Participants and treating clinicians were not blinded.
Assessments occurred at baseline, 3 months, and 6 months. Baseline was the preoperative visit for SG participants and the enrollment visit for NSG participants. Weight and height were measured, and body mass index was calculated. A single calibrated examiner performed full-mouth periodontal examinations at six sites per tooth, excluding third molars. Measures included plaque index, probing pocket depth, clinical attachment level, and bleeding on probing. Unstimulated whole saliva was collected by passive drooling between 08:00 and 10:00 after at least 2 hours without eating, drinking, smoking, toothbrushing, or mouthrinse use. Samples were centrifuged, aliquoted, stored at -80 °C, and analyzed in duplicate for salivary IL-6 and TNF-α using commercial ELISA kits. All participants received standardized oral-hygiene instructions at baseline and were advised to maintain their usual oral care. No periodontal treatment was provided during follow-up unless clinically necessary.
The primary outcomes were longitudinal changes in salivary IL-6 and TNF-α, with the principal comparison from baseline to 6 months. Secondary outcomes were longitudinal changes in plaque index, bleeding on probing, probing pocket depth, and clinical attachment level. Body weight and body mass index were contextual outcomes. Exploratory analyses examined associations between cytokine and periodontal measures. The study was designed as a pilot to assess feasibility, refine procedures, and estimate preliminary effect sizes rather than establish definitive efficacy. A formal efficacy sample-size calculation was not performed; the target sample was based on recruitment feasibility, surgical scheduling capacity, ability to complete repeated periodontal and saliva visits, and available time and funding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to laparoscopic sleeve gastrectomy or non-surgical management. Simple computer-generated randomization was used without blocking or stratification. The unequal 18/14 allocation arose by chance in the small pilot sample; no post-allocation rebalancing was performed.
| Arm | Type | Receives |
|---|---|---|
| Sleeve Gastrectomy Group (SG) | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy, Other: Non-Surgical Obesity Management, Behavioral: Standardized Oral-Hygiene InstructionsParticipants allocated to SG underwent laparoscopic sleeve gastrectomy and completed anthropometric, periodontal, and saliva assessments at baseline, 3 months, and 6 months. They also received standardized oral-hygiene instructions at baseline; no periodontal treatment was provided during follow-up unless clinically necessary. |
| Non-Surgical Management Group (NSG) | Active comparator | Procedure: Laparoscopic Sleeve Gastrectomy, Other: Non-Surgical Obesity Management, Behavioral: Standardized Oral-Hygiene InstructionsParticipants allocated to NSG received non-surgical management over the same follow-up period and completed anthropometric, periodontal, and saliva assessments at baseline, 3 months, and 6 months. They also received standardized oral-hygiene instructions at baseline; no periodontal treatment was provided during follow-up unless clinically necessary |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years.
- Body mass index (BMI) ≥35 kg/m² with one or more obesity-related comorbidities, or BMI ≥40 kg/m².
- Stage I-III periodontitis according to the 2018 periodontitis stage/grade classification.
- At least 12 natural teeth in each dental arch.
- Written informed consent provided before enrollment.
Key exclusion criteria (9 listed)
- • Smoking more than 10 cigarettes per day.
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 |
|---|---|---|
| Laparoscopic Sleeve GastrectomyParticipants randomized to the SG arm underwent laparoscopic sleeve gastrectomy as their obesity treatment. | Procedure or surgery | Non-Surgical Management Group (NSG), Sleeve Gastrectomy Group (SG) |
| Non-Surgical Obesity Managementconservative management | Other | Non-Surgical Management Group (NSG), Sleeve Gastrectomy Group (SG) |
| Standardized Oral-Hygiene InstructionsAll participants received standardized oral-hygiene instructions at baseline and were advised to maintain their usual oral-care habits throughout follow-up. No periodontal treatment was provided during follow-up unless clinically necessary | Behavioural | Non-Surgical Management Group (NSG), Sleeve Gastrectomy Group (SG) |
Primary outcome
Change from baseline in salivary interleukin-6 (IL-6) concentration at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Unstimulated whole saliva is collected by passive drooling for 5 minutes between 08:00 and 10:00 after at least 2 hours without eating, drinking, smoking, toothbrushing, or mouthrinse use. Samples are centrifuged at 3000 rpm for 10 minutes at 4 °C, aliquoted, and stored at -80 °C. IL-6 is measured with a commercial ELISA kit in duplicate; the duplicate mean is reported in pg/mL. The outcome is the within-participant change from baseline at each follow-up, with the principal endpoint at 6 months.
Change from baseline in salivary tumor necrosis factor-alpha (TNF-α) concentration at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Unstimulated whole saliva is collected and processed under the same standardized conditions as for IL-6. TNF-α is measured with a commercial ELISA kit in duplicate; the duplicate mean is reported in pg/mL. The outcome is the within-participant change from baseline at each follow-up, with the principal endpoint at 6 months
4 secondary outcomes
Change from baseline in full-mouth Plaque Index at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in bleeding on probing at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in full-mouth mean probing pocket depth at 3 and 6 months
Time frame: Baseline, 3 months, and 6 months
Change from baseline in full-mouth mean clinical attachment level at 3 and 6 months
Time frame: Baseline, 3 months, and 6 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 28 Jul 2026.
- Background: PubMed 42652142Beresescu FG, Monea A, Ormenisan A, Tegla C, Cosarca A, Voidazan S. Short-Term Changes in Salivary IL-6, TNF-alpha, and Periodontal Inflammation Following Sleeve Gastrectomy in Patients with Obesity: A Randomized Controlled Pilot Study. Biomedicines. 2026 Aug 4;14(8):1759. doi: 10.3390/biomedicines14081759.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Sleeve Gastrectomy, Non-Surgical Obesity Management and Standardized Oral-Hygiene Instructions in people with Obesity and Periodontitis, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 1 site in Romania.
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 5 inclusion and 9 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 28 Jul 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 Romania. 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?
Change from baseline in salivary interleukin-6 (IL-6) concentration at 3 and 6 months (time frame: Baseline, 3 months, and 6 months). The study lists 2 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 NCT07731412, 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 28 Jul 2026.