PeriodontitisNCT07077122
Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols
A study testing Scaling and Root Planing, antibiotic prophylaxis and 810nm Diode Laser in people with Periodontitis, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Periodontitis is a chronic inflammatory disease of the periodontal tissues leading to the destruction of the tooth supporting structures. Despite the fact that periodontal bacteria are etiological agents, host susceptibility related to the inflammatory response to plaque bacteria is the main determinant of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and Root Planing, antibiotic prophylaxis and 810nm Diode Laser
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGreece
- Study dates
- 25 Aug 2025to 15 Dec 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Periodontitis stage III or IV
- Non-smokers or light smokers (<10 cigarettes/day)
- No NSAIDs in regular basis or antibiotics 3 months before
- No previous periodontal treatment 12 months before
- No presence of other acute or chronic infections
- No systemic disease or medication known to affect the serum level of inflammatory markers (cyclooxygenase inhibitors, platelet aggregation inhibitors, lipid lowering agents, â-adrenoreceptor antagonists, angiotensin converting enzyme inhibitors, antidiabetic agents, estrogen-based medications, medication for autoimmune disease, magnesium or vitamin E supplements)
- No pregnancy or lactation
- Written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Department of Periodontology, Dental School of Athens
Athens
Prof. Madianos P., DDS, PhD, 00302107461181, pmadian@dent.uoa.gr
About this study
Periodontitis is a chronic inflammatory disease of the periodontal tissues leading to the destruction of the tooth supporting structures. Despite the fact that periodontal bacteria are etiological agents, host susceptibility related to the inflammatory response to plaque bacteria is the main determinant of the development of periodontitis. Non-surgical periodontal therapy (NSPT) represents the base of any therapeutic approach. Its main component is the removal of bacterial deposits, i.e. soft biofilm or mineralized calculus, from the tooth surface via mechanical debridement.
It is well established that patients suffering from periodontitis present with a low-grade systemic inflammatory state when compared to healthy subjects. Increased concentrations of inflammatory biomarkers in systemic circulation, such as, C-reactive protein (CRP) and interleukin (IL)-6, have already been reported. A significant amount of evidence derived from epidemiological as well as experimental studies has implicated periodontitis as a putative risk factor for a number of systemic diseases, such as, cardiovascular diseases, diabetes and respiratory diseases having systemic low-grade inflammation as their underlying pathogenic mechanism. Furthermore, several intervention studies provide evidence that periodontal treatment may improve systemic inflammatory markers and potentially reduce the risk for cardio-metabolic diseases.
Read more
However, periodontal therapy may pose a transient, short-term health hazard immediately after instrumentation of the root surface presumably due to the spill of bacteria and their products in the systemic circulation and the subsequent acute inflammatory response. Positive bacteremia in NSPT ranges from 13% to 80.9% after mechanical debridement depending primarily on the periodontal status of the patient, but also on the study design and the microbiological methodology.
Finally, an important aspect concerning NSPT is method and duration of delivery. NSPT may be carried out with either hand instruments, power driven instruments, such as, ultrasonic and sonic or a "blended approach" using both. Besides these instruments, the adjunctive use of lasers or/and air powder technology has been proposed. Regarding duration, treatment may be staged over several visits with a quadrant approach, or with a full-mouth debridement approach, also referred to as an intensive treatment approach, which delivers complete debridement within 24 hours.
The aim of this clinical trial is to assess the immediate systemic burden of five different treatment protocols for the NSPT on:
- bacteremia
- serum inflammatory responses. Additionally, saliva CRP levels will be assessed and compared to serum. Moreover, the effectiveness of the treatment protocols on clinical periodontal parameters will be assessed.
- Conditions
- Periodontitis
- Being tested
- Scaling and Root Planing, antibiotic prophylaxis, 810nm Diode Laser, Air Polishing
- Keywords
- periodontitis, inflammatory markers, non-surgical periodontal therapy, bacteremia
- Medical subject headings
- Periodontitis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Mechanical debridement of tooth surfaces using hand and ultrasonic instruments
antibiotic prophylaxisDrug
2g Amoxicillin given 1 hour prior to instrumentation
810nm Diode LaserDevice
Laser applied at base of gingival pockets prior to mechanical debridement.
Air PolishingProcedure or surgery
air flow-based mechanical debridement with erythritol powder
| Study group | Role | What they receive |
|---|---|---|
| Full-Mouth SRP | Experimental | oral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. Receives: Procedure: Scaling and Root Planing |
| SRP + Antibiotics | Experimental | oral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks. Receives: Procedure: Scaling and Root Planing; Drug: antibiotic prophylaxis |
| SRP + Laser | Experimental | oral hygiene instructions and 810nm diode laser at the base of the gingival sulcus/pocket following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. Receives: Procedure: Scaling and Root Planing; Device: 810nm Diode Laser |
| SRP + Air Polishing | Experimental | oral hygiene instructions and air polishing following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. Receives: Procedure: Scaling and Root Planing; Procedure: Air Polishing |
| Quadrant SRP (Control) | Active comparator | Oral hygiene instructions, scaling and root planing per quadrant with an interval of 7 days per session. Clinical re-evaluation in 8 weeks after last session. Receives: Procedure: Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum high-sensitivity C-reactive protein (hs-CRP) levels
For hs-CRP, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Secondary outcomes (15)
Changes in serum Interleukin 6 (IL-6)
For IL-6, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Presence and load of bacteremia
culture, PCR, 16S rRNA sequencing
Measured: Baseline-15 minutes after the last periodontal session
Changes in mean Clinical Attachment Level (CAL)
CAL would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.
All clinical measurements would be taken using a manual probe. CAL would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Measured: Baseline-8 weeks after the last periodontal session
Salivary CRP correlation with serum CRP
saliva CRP levels will be assessed and compared to serum
Measured: Baseline-7 days after the last periodontal session
Changes in serum Tumor Necrosis Factor a (TNF-a) levels
For changes in TNF-a levels, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Changes in Serum amyloid A (SAA) levels
For changes in SAA levels, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Changes in Serum cystatin c levels
For changes in serum cystatin c levels, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Changes in Matrix metalloproteinase-8 (MMP-8) levels
For changes in MMP-8 levels, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Changes in serum D-dimers levels
For changes in serum D-dimers levels, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Changes in serum Lipopolysaccharide (LPS) levels
For changes in serum LPS levels, blood would be collected:
- Before each periodontal session
- 24 hours after each periodontal session
- 7 days after each periodontal session
Measured: Baseline-7 days after the last periodontal session
Changes in mean Pocket Depth (PD)
PD would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.
All clinical measurements would be taken using a manual probe. PD would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Measured: Baseline-8 weeks after the last periodontal session
Changes in mean Gingival Recession (GR)
GR would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.
All clinical measurements would be taken using a manual probe. GR would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Measured: Baseline-8 weeks after the last periodontal session
Changes in Full-Mouth Plaque Score (FMPS)
FMPS would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session.
All clinical measurements would be taken using a manual probe. FMPS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Measured: Baseline-8 weeks after the last periodontal session
Changes in Full-Mouth Bleeding Score (FMBS)
FMBS would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session. All clinical measurements would be taken using a manual probe. FMBS would be recorded at six sites per tooth. Third molars would be excluded from the measurements.
Measured: Baseline-8 weeks after the last periodontal session
Changes in simplified gingival index (s-GI)
s-GI would be assessed before treatment initiation and would then be recorded at 8 weeks after the last periodontal session. All clinical measurements would be taken using a manual probe. s-GI would be recorded at four sites per tooth. Third molars would be excluded from the measurements.
Measured: Baseline-8 weeks after the last periodontal session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Aug 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Zampa, National and Kapodistrian University of Athens
- Investigators
- Madianos Phoebus, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077122
- Sponsor's protocol ID
- 688/11.02.2025
- Other IDs
- Ethics committee
- Status last verified
- Aug 2025
- First submitted
- 30 Jun 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Publications
Sanz M, Marco Del Castillo A, Jepsen S, Gonzalez-Juanatey JR, D'Aiuto F, Bouchard P, Chapple I, Dietrich T, Gotsman I, Graziani F, Herrera D, Loos B, Madianos P, Michel JB, Perel P, Pieske B, Shapira L, Shechter M, Tonetti M, Vlachopoulos C, Wimmer G. Periodontitis and cardiovascular diseases: Consensus report. J Clin Periodontol. 2020 Mar;47(3):268-288. doi: 10.1111/jcpe.13189. Epub 2020 Feb 3.
PubMed 32011025Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
PubMed 32383274Kinane DF, Riggio MP, Walker KF, MacKenzie D, Shearer B. Bacteraemia following periodontal procedures. J Clin Periodontol. 2005 Jul;32(7):708-13. doi: 10.1111/j.1600-051X.2005.00741.x.
PubMed 15966875
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Systemic Burden of Non-surgical Periodontal Therapy: A Randomized Clinical Trial on Five Different Treatment Protocols
- ClinicalTrials.gov ID
- NCT07077122
- Acronym / sponsor ID
- 688/11.02.2025
- Conditions
- Periodontitis
- Keywords
- periodontitis, inflammatory markers, non-surgical periodontal therapy, bacteremia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 22 Jul 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.
Periodontitis is a chronic inflammatory disease of the periodontal tissues leading to the destruction of the tooth supporting structures. Despite the fact that periodontal bacteria are etiological agents, host susceptibility related to the inflammatory response to plaque bacteria is the main determinant of the development of periodontitis. Non-surgical periodontal therapy (NSPT) represents the base of any therapeutic approach. Its main component is the removal of bacterial deposits, i.e. soft biofilm or mineralized calculus, from the tooth surface via mechanical debridement.
It is well established that patients suffering from periodontitis present with a low-grade systemic inflammatory state when compared to healthy subjects. Increased concentrations of inflammatory biomarkers in systemic circulation, such as, C-reactive protein (CRP) and interleukin (IL)-6, have already been reported. A significant amount of evidence derived from epidemiological as well as experimental studies has implicated periodontitis as a putative risk factor for a number of systemic diseases, such as, cardiovascular diseases, diabetes and respiratory diseases having systemic low-grade inflammation as their underlying pathogenic mechanism. Furthermore, several intervention studies provide evidence that periodontal treatment may improve systemic inflammatory markers and potentially reduce the risk for cardio-metabolic diseases.
However, periodontal therapy may pose a transient, short-term health hazard immediately after instrumentation of the root surface presumably due to the spill of bacteria and their products in the systemic circulation and the subsequent acute inflammatory response. Positive bacteremia in NSPT ranges from 13% to 80.9% after mechanical debridement depending primarily on the periodontal status of the patient, but also on the study design and the microbiological methodology.
Finally, an important aspect concerning NSPT is method and duration of delivery. NSPT may be carried out with either hand instruments, power driven instruments, such as, ultrasonic and sonic or a "blended approach" using both. Besides these instruments, the adjunctive use of lasers or/and air powder technology has been proposed. Regarding duration, treatment may be staged over several visits with a quadrant approach, or with a full-mouth debridement approach, also referred to as an intensive treatment approach, which delivers complete debridement within 24 hours.
The aim of this clinical trial is to assess the immediate systemic burden of five different treatment protocols for the NSPT on:
- bacteremia
- serum inflammatory responses. Additionally, saliva CRP levels will be assessed and compared to serum. Moreover, the effectiveness of the treatment protocols on clinical periodontal parameters will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Full-Mouth SRP | Experimental | Procedure: Scaling and Root Planingoral hygiene instructions and full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. |
| SRP + Antibiotics | Experimental | Procedure: Scaling and Root Planing, Drug: antibiotic prophylaxisoral hygiene instructions and full mouth scaling and root planing in 24 hours along with antibiotic prophylaxis. Clinical re-evaluation in 8 weeks. |
| SRP + Laser | Experimental | Procedure: Scaling and Root Planing, Device: 810nm Diode Laseroral hygiene instructions and 810nm diode laser at the base of the gingival sulcus/pocket following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. |
| SRP + Air Polishing | Experimental | Procedure: Scaling and Root Planing, Procedure: Air Polishingoral hygiene instructions and air polishing following by full mouth scaling and root planing in 24 hours. Clinical re-evaluation in 8 weeks. |
| Quadrant SRP (Control) | Active comparator | Procedure: Scaling and Root PlaningOral hygiene instructions, scaling and root planing per quadrant with an interval of 7 days per session. Clinical re-evaluation in 8 weeks after last session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Periodontitis stage III or IV
- Non-smokers or light smokers (<10 cigarettes/day)
- No NSAIDs in regular basis or antibiotics 3 months before
- No previous periodontal treatment 12 months before
- No presence of other acute or chronic infections
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Scaling and Root PlaningMechanical debridement of tooth surfaces using hand and ultrasonic instruments | Procedure or surgery | Full-Mouth SRP, Quadrant SRP (Control), SRP + Air Polishing, SRP + Antibiotics, SRP + Laser |
| antibiotic prophylaxis2g Amoxicillin given 1 hour prior to instrumentation | Drug | SRP + Antibiotics |
| 810nm Diode LaserLaser applied at base of gingival pockets prior to mechanical debridement. | Device | SRP + Laser |
| Air Polishingair flow-based mechanical debridement with erythritol powder | Procedure or surgery | SRP + Air Polishing |
Primary outcome
Change in serum high-sensitivity C-reactive protein (hs-CRP) levels
Time frame: Baseline-7 days after the last periodontal session
For hs-CRP, blood would be collected: * Before each periodontal session * 24 hours after each periodontal session * 7 days after each periodontal session
15 secondary outcomes
Changes in serum Interleukin 6 (IL-6)
Time frame: Baseline-7 days after the last periodontal session
Presence and load of bacteremia
Time frame: Baseline-15 minutes after the last periodontal session
Changes in mean Clinical Attachment Level (CAL)
Time frame: Baseline-8 weeks after the last periodontal session
Salivary CRP correlation with serum CRP
Time frame: Baseline-7 days after the last periodontal session
Changes in serum Tumor Necrosis Factor a (TNF-a) levels
Time frame: Baseline-7 days after the last periodontal session
Changes in Serum amyloid A (SAA) levels
Time frame: Baseline-7 days after the last periodontal session
Changes in Serum cystatin c levels
Time frame: Baseline-7 days after the last periodontal session
Changes in Matrix metalloproteinase-8 (MMP-8) levels
Time frame: Baseline-7 days after the last periodontal session
Changes in serum D-dimers levels
Time frame: Baseline-7 days after the last periodontal session
Changes in serum Lipopolysaccharide (LPS) levels
Time frame: Baseline-7 days after the last periodontal session
Changes in mean Pocket Depth (PD)
Time frame: Baseline-8 weeks after the last periodontal session
Changes in mean Gingival Recession (GR)
Time frame: Baseline-8 weeks after the last periodontal session
Changes in Full-Mouth Plaque Score (FMPS)
Time frame: Baseline-8 weeks after the last periodontal session
Changes in Full-Mouth Bleeding Score (FMBS)
Time frame: Baseline-8 weeks after the last periodontal session
Changes in simplified gingival index (s-GI)
Time frame: Baseline-8 weeks after the last periodontal session
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 Sep 2025.
- Results publication: PubMed 32011025Sanz M, Marco Del Castillo A, Jepsen S, Gonzalez-Juanatey JR, D'Aiuto F, Bouchard P, Chapple I, Dietrich T, Gotsman I, Graziani F, Herrera D, Loos B, Madianos P, Michel JB, Perel P, Pieske B, Shapira L, Shechter M, Tonetti M, Vlachopoulos C, Wimmer G. Periodontitis and cardiovascular diseases: Consensus report. J Clin Periodontol. 2020 Mar;47(3):268-288. doi: 10.1111/jcpe.13189. Epub 2020 Feb 3.
- Results publication: PubMed 32383274Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
- Results publication: PubMed 15966875Kinane DF, Riggio MP, Walker KF, MacKenzie D, Shearer B. Bacteraemia following periodontal procedures. J Clin Periodontol. 2005 Jul;32(7):708-13. doi: 10.1111/j.1600-051X.2005.00741.x.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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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.
Madianos Phoebus study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing, antibiotic prophylaxis and 810nm Diode Laser in people with Periodontitis, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 8 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 Greece. 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?
Contact Zampa Evangelia (00306987027896, elina_zampa@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum high-sensitivity C-reactive protein (hs-CRP) levels (time frame: Baseline-7 days after the last periodontal session). 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 NCT07077122, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.