SalivaNCT06809439
Comparison of Saliva Biomarkers in Two Different Geographical Regions of Turkey
A study testing Non-Surgical Intervention, Saliva Collection (Baseline) and Probing in people with Saliva and Cortisol, run by Karabuk University at 2 sites in Turkey (Türkiye).
Trial summary
Periodontitis is a multifactorial, chronic inflammatory disease caused by many factors such as pathogenic microorganisms, host response, environmental and systemic factors. Immune mechanisms triggered by host-bacteria interaction can initiate tissue destruction by leading to the release of large amounts of… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Saliva, Cortisol, Smoking, Tobacco
- What is being tested?
- Non-Surgical Intervention, Saliva Collection (Baseline) and Probing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 3 Jul 2023
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 35-60 years of age
- good cooperation
- a minimum of 20 permanent teeth, excluding third molars
Who cannot join
- systemic diseases
- taking any medications
- received antibiotic treatment in the last three months
- those who had undergone periodontal treatment six months ago
- pregnant or breastfeeding patients
- prosthetic restorations
- undergoing orthodontic treatment
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
AnkaraUniversity
Ankara, 06560
Karabuk University
Karabük, 78100
About this study
Official title: Comparison of Salivary RANKL, OPG, IL-10, IL-1β and Cortisol Levels With Non-surgical Periodontal Treatment in Periodontitis Patients Living in Two Different Geographical Regions in Turkey
Periodontitis is a multifactorial, chronic inflammatory disease caused by many factors such as pathogenic microorganisms, host response, environmental and systemic factors. Immune mechanisms triggered by host-bacteria interaction can initiate tissue destruction by leading to the release of large amounts of inflammatory mediators such as IL-1β. It is thought that IL-10 has a regulatory role by limiting the initiation and progression of the acute inflammatory response with its anti-inflammatory effect. The high detection of RANKL and RANKL/OPG ratios in periodontitis indicates that these markers play a role in bone destruction. Elucidating the connections between the immune system and bone-related cytokines will contribute significantly to the resolution of these complex mechanisms underlying periodontal diseases. Risk factors for periodontal diseases include gender, age, smoking and some hereditary factors. Cortisol is an important marker of psychological stress. It is emphasized that stress and depression reduce immune system function and cause chronic inflammation. Thus, it indirectly provokes periodontal tissue destruction.
Read the detailed description
This study consists of patients and healthy volunteers. Saliva will be collected only once from healthy volunteers; from patients at the beginning and after non-surgical periodontal treatments are performed by the researchers. In the collected saliva; clinical parameters and salivary RANKL, OPG, IL-10, IL-1β, cortisol levels will be determined in periodontitis and periodontally healthy individuals living in two different geographical regions in Turkey (Ankara -Erzurum); it will be determined whether non-surgical periodontal treatment has an effect on cytokines determined in saliva and clinical status at the end of 1-month follow-up period; periodontal pathogenesis and host response will be evaluated in smoker and non-smoker groups. Analyses will be performed by ELISA method.
The study is based on the hypothesis that "different regional and geographical conditions determining climate, culture, environment, life, stress situations affect the course of periodontitis disease and host response". A regional comparison will be made between markers that affect the course of periodontitis disease and play a role in its pathogenesis in patients with different climate, living and cultural conditions, according to location.
- Conditions
- Saliva, Cortisol, Smoking, Tobacco, Periodontal Bone Loss, Periodontal Disease, Periodontal Therapy
- Being tested
- Non-Surgical Intervention, Saliva Collection (Baseline), Probing, Saliva Collection (After treatment)
- Keywords
- RANKL, osteoprotegerin, interleukin-10, non-surgical periodontal therapy, periodontitis, saliva, enviromental, geographical locations
- Medical subject headings
- Tobacco Smoking, Alveolar Bone Loss, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical InterventionProcedure or surgery
Oral hygiene instructions including tooth brushing, flossing, and interdental brushing were given to all patient groups before non-surgical periodontal treatment. In both periodontitis groups, scaling, and root surface smoothing were performed using ultrasonic instruments (Woodpecker Medicals Ins. Co., USA) and Gracey Curettes (Hu-Friedy, Chicago, IL, USA) under local anesthesia once a week for 4 weeks.
Saliva Collection (Baseline)Diagnostic test
Unstimulated saliva samples were collected from all participants between 9:00 and 11:00 am. Clinical periodontal measurements were performed after saliva collection to prevent contamination (bleeding, etc.). Participants refrained from brushing their teeth the morning before sampling and from eating, drinking, or smoking for at least 2 hours before sampling. Patients were asked to rinse their mouths with distilled water 5 minutes before saliva collection. A saliva sample was then collected by spitting directly into a sterile tube. Sample collection was continued for 5 minutes.
ProbingOther
Clinical and radiographic evaluations were performed by trained and calibrated examiners at Ankara University (SY) and Ataturk University (OT). Clinical parameters of probing depth (PPD), clinical attachment level CAL, plaque index PI, and bleeding on probing (BOP) were recorded from six tooth regions (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, middle lingual, and disto-lingual) using periodontal probe. Bone loss was assessed using panoramic radiographs, confirming the diagnosis of periodontitis.
Saliva Collection (After treatment)Diagnostic test
Unstimulated saliva samples were collected from all participants between 9:00 and 11:00 am. Clinical periodontal measurements were performed after saliva collection to prevent contamination (bleeding, etc.). Participants refrained from brushing their teeth the morning before sampling and from eating, drinking, or smoking for at least 2 hours before sampling. Patients were asked to rinse their mouths with distilled water 5 minutes before saliva collection. A saliva sample was then collected by spitting directly into a sterile tube. Sample collection was continued for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control Ankara | Experimental | Healthy group at Ankara University. Total smokers and non-smokers with clinically healthy gingiva, no deep gingival pockets (≤3mm) and no attachment loss, no bleeding on probing or <10%, no radiographic bone loss were included in the study.
Clinical parameters were recorded and saliva was collected in this group. Receives: Diagnostic Test: Saliva Collection (Baseline); Other: Probing |
| Control Atatürk | Experimental | Healthy group at Atatürk University. A total of patients with clinically healthy gums, no deep gingival pockets (≤3 mm) and attachment loss, no bleeding on probing or <10%, no radiographic bone loss, smokers and non-smokers were included in the study. Clinical parameters were recorded and saliva was collected in this group. Receives: Diagnostic Test: Saliva Collection (Baseline); Other: Probing |
| Periodontitis Ankara | Experimental | Smoker patient who applied to Ankara University, Faculty of Dentistry, Department of Periodontics, diagnosed with Stage III periodontitis with a clinically probed pocket depth of more than 5 mm and radiographically ≥3 mm bone loss, smoker patient diagnosed with Stage III.In this group, baseline and post-treatment clinical parameters were recorded and saliva was collected. Receives: Procedure: Non-Surgical Intervention; Diagnostic Test: Saliva Collection (Baseline); Other: Probing; Diagnostic Test: Saliva Collection (After treatment) |
| Periodontitis Atatürk | Experimental | Twenty-two patients who applied to the Department of Periodontics, Faculty of Dentistry, Ataturk University, and were diagnosed with Stage III Grade A periodontitis, 11 smokers and 11 smokers, with clinically probed pocket depths greater than 5 mm and radiographically ≥3 mm bone loss. Receives: Procedure: Non-Surgical Intervention; Diagnostic Test: Saliva Collection (Baseline); Other: Probing; Diagnostic Test: Saliva Collection (After treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study population, pre-treatment and post-treatment periodontal clinical parameters
This study included 10 systemically healthy non-smokers from Ankara with stage III, grade B generalized periodontitis, 8 smokers with stage III, grade C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers. In Erzurum, systemically healthy, 9 non-smokers, stage III B generalized periodontitis , 6 smokers (≥10/day), stage III C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers were included. Clinical parameters of probing depth (PPD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP) were recorded . All clinical measurements were made after saliva samples were taken and recorded as initial values. The periodontal index form was used for this purpose. (https://www.periodontalchart-online.com/uk/) Nonsurgical periodontal treatments lasted 4 weeks. Baseline and post-treatment periodontal parameters were compared.
Measured: up to 4 weeks
Secondary outcomes (1)
Salivary biomarkers
Saliva IL-1β (pg/ml), cortisol (ng/ml), RANKL (pg/ml), OPG(ng/ml), and IL-10 (pg/ml) concentrations were assessed via ELISA. The baseline saliva of the control groups and the pre- and post-treatment salivary biochemical parameters of the treatment groups were similar in both cities evaluated.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start2 Jan 2023
- Primary completion8 May 2023
- Study completion3 Jul 2023
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 SalivaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 77 subjects in Ankara and Erzurum, 19 non-smokers (NS-P) with stage III, grade B generalized periodontitis and 14 smokers (SP) with stage III, grade C generalized periodontitis, as well as 22 non-smokers (NS-C) and 22 smokers (SC) periodontally healthy control cases were included in the study.Periodontal parameters were recorded, and unstimulated saliva samples were collected from all patients. Periodontitis patients (N=33) were evaluated clinically and biochemically (saliva IL-1β, cortisol, RANKL, OPG, and IL-10) 4 weeks after complete oral cleansing and root correction (SRP). Saliva samples were analyzed using enzyme-linked immunosorbent assay (ELISA). The data were analyzed using the SPSS software version 22.0.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University, Ankara University
- Responsible party
- Principal investigator, Sevilay Yeğinoğlu, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809439
- Sponsor's protocol ID
- ApprovalNo:11/04, 09.05.2022
- Other IDs
- TSA-2022-2551
- Status last verified
- Sep 2024
- First submitted
- 16 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the saliva biomarker statistics of the study as an excel file when requested. Our Turkish study protocol has also received approval (ethics committee decision).
Publications
Mengel R, Bacher M, Flores-De-Jacoby L. Interactions between stress, interleukin-1beta, interleukin-6 and cortisol in periodontally diseased patients. J Clin Periodontol. 2002 Nov;29(11):1012-22. doi: 10.1034/j.1600-051x.2002.291106.x.
PubMed 12472994
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Salivary RANKL, OPG, IL-10, IL-1β and Cortisol Levels With Non-surgical Periodontal Treatment in Periodontitis Patients Living in Two Different Geographical Regions in Turkey
- ClinicalTrials.gov ID
- NCT06809439
- Acronym / sponsor ID
- ApprovalNo:11/04, 09.05.2022
- Conditions
- Saliva, Cortisol, Smoking, Tobacco, Periodontal Bone Loss, Periodontal Disease, Periodontal Therapy
- Keywords
- RANKL, osteoprotegerin, interleukin-10, non-surgical periodontal therapy, periodontitis, saliva, enviromental, geographical locations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Collaborators
- Ataturk University, Ankara University
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 5 Feb 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 multifactorial, chronic inflammatory disease caused by many factors such as pathogenic microorganisms, host response, environmental and systemic factors. Immune mechanisms triggered by host-bacteria interaction can initiate tissue destruction by leading to the release of large amounts of inflammatory mediators such as IL-1β. It is thought that IL-10 has a regulatory role by limiting the initiation and progression of the acute inflammatory response with its anti-inflammatory effect. The high detection of RANKL and RANKL/OPG ratios in periodontitis indicates that these markers play a role in bone destruction. Elucidating the connections between the immune system and bone-related cytokines will contribute significantly to the resolution of these complex mechanisms underlying periodontal diseases. Risk factors for periodontal diseases include gender, age, smoking and some hereditary factors. Cortisol is an important marker of psychological stress. It is emphasized that stress and depression reduce immune system function and cause chronic inflammation. Thus, it indirectly provokes periodontal tissue destruction.
Detailed description
This study consists of patients and healthy volunteers. Saliva will be collected only once from healthy volunteers; from patients at the beginning and after non-surgical periodontal treatments are performed by the researchers. In the collected saliva; clinical parameters and salivary RANKL, OPG, IL-10, IL-1β, cortisol levels will be determined in periodontitis and periodontally healthy individuals living in two different geographical regions in Turkey (Ankara -Erzurum); it will be determined whether non-surgical periodontal treatment has an effect on cytokines determined in saliva and clinical status at the end of 1-month follow-up period; periodontal pathogenesis and host response will be evaluated in smoker and non-smoker groups. Analyses will be performed by ELISA method.
The study is based on the hypothesis that "different regional and geographical conditions determining climate, culture, environment, life, stress situations affect the course of periodontitis disease and host response". A regional comparison will be made between markers that affect the course of periodontitis disease and play a role in its pathogenesis in patients with different climate, living and cultural conditions, according to location.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A total of 77 subjects in Ankara and Erzurum, 19 non-smokers (NS-P) with stage III, grade B generalized periodontitis and 14 smokers (SP) with stage III, grade C generalized periodontitis, as well as 22 non-smokers (NS-C) and 22 smokers (SC) periodontally healthy control cases were included in the study.Periodontal parameters were recorded, and unstimulated saliva samples were collected from all patients. Periodontitis patients (N=33) were evaluated clinically and biochemically (saliva IL-1β, cortisol, RANKL, OPG, and IL-10) 4 weeks after complete oral cleansing and root correction (SRP). Saliva samples were analyzed using enzyme-linked immunosorbent assay (ELISA). The data were analyzed using the SPSS software version 22.0.
| Arm | Type | Receives |
|---|---|---|
| Control Ankara | Experimental | Diagnostic Test: Saliva Collection (Baseline), Other: ProbingHealthy group at Ankara University. Total smokers and non-smokers with clinically healthy gingiva, no deep gingival pockets (≤3mm) and no attachment loss, no bleeding on probing or <10%, no radiographic bone loss were included in the study. Clinical parameters were recorded and saliva was collected in this group. |
| Control Atatürk | Experimental | Diagnostic Test: Saliva Collection (Baseline), Other: ProbingHealthy group at Atatürk University. A total of patients with clinically healthy gums, no deep gingival pockets (≤3 mm) and attachment loss, no bleeding on probing or <10%, no radiographic bone loss, smokers and non-smokers were included in the study. Clinical parameters were recorded and saliva was collected in this group. |
| Periodontitis Ankara | Experimental | Procedure: Non-Surgical Intervention, Diagnostic Test: Saliva Collection (Baseline), Other: Probing, Diagnostic Test: Saliva Collection (After treatment)Smoker patient who applied to Ankara University, Faculty of Dentistry, Department of Periodontics, diagnosed with Stage III periodontitis with a clinically probed pocket depth of more than 5 mm and radiographically ≥3 mm bone loss, smoker patient diagnosed with Stage III.In this group, baseline and post-treatment clinical parameters were recorded and saliva was collected. |
| Periodontitis Atatürk | Experimental | Procedure: Non-Surgical Intervention, Diagnostic Test: Saliva Collection (Baseline), Other: Probing, Diagnostic Test: Saliva Collection (After treatment)Twenty-two patients who applied to the Department of Periodontics, Faculty of Dentistry, Ataturk University, and were diagnosed with Stage III Grade A periodontitis, 11 smokers and 11 smokers, with clinically probed pocket depths greater than 5 mm and radiographically ≥3 mm bone loss. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 35-60 years of age
- good cooperation
- a minimum of 20 permanent teeth, excluding third molars
Key exclusion criteria (7 listed)
- systemic diseases
- taking any medications
- received antibiotic treatment in the last three months
- those who had undergone periodontal treatment six months ago
- pregnant or breastfeeding patients
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 |
|---|---|---|
| Non-Surgical InterventionOral hygiene instructions including tooth brushing, flossing, and interdental brushing were given to all patient groups before non-surgical periodontal treatment. In both periodontitis groups, scaling, and root surface smoothing were performed using ultrasonic instruments (Woodpecker Medicals Ins. Co., USA) and Gracey Curettes (Hu-Friedy, Chicago, IL, USA) under local anesthesia once a week for 4 weeks. | Procedure or surgery | Periodontitis Ankara, Periodontitis Atatürk |
| Saliva Collection (Baseline)Unstimulated saliva samples were collected from all participants between 9:00 and 11:00 am. Clinical periodontal measurements were performed after saliva collection to prevent contamination (bleeding, etc.). Participants refrained from brushing their teeth the morning before sampling and from eating, drinking, or smoking for at least 2 hours before sampling. Patients were asked to rinse their mouths with distilled water 5 minutes before saliva collection. A saliva sample was then collected by spitting directly into a sterile tube. Sample collection was continued for 5 minutes. | Diagnostic test | Control Ankara, Control Atatürk, Periodontitis Ankara, Periodontitis Atatürk |
| ProbingClinical and radiographic evaluations were performed by trained and calibrated examiners at Ankara University (SY) and Ataturk University (OT). Clinical parameters of probing depth (PPD), clinical attachment level CAL, plaque index PI, and bleeding on probing (BOP) were recorded from six tooth regions (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, middle lingual, and disto-lingual) using periodontal probe. Bone loss was assessed using panoramic radiographs, confirming the diagnosis of periodontitis. | Other | Control Ankara, Control Atatürk, Periodontitis Ankara, Periodontitis Atatürk |
| Saliva Collection (After treatment)Unstimulated saliva samples were collected from all participants between 9:00 and 11:00 am. Clinical periodontal measurements were performed after saliva collection to prevent contamination (bleeding, etc.). Participants refrained from brushing their teeth the morning before sampling and from eating, drinking, or smoking for at least 2 hours before sampling. Patients were asked to rinse their mouths with distilled water 5 minutes before saliva collection. A saliva sample was then collected by spitting directly into a sterile tube. Sample collection was continued for 5 minutes. | Diagnostic test | Periodontitis Ankara, Periodontitis Atatürk |
Primary outcome
Study population, pre-treatment and post-treatment periodontal clinical parameters
Time frame: up to 4 weeks
This study included 10 systemically healthy non-smokers from Ankara with stage III, grade B generalized periodontitis, 8 smokers with stage III, grade C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers. In Erzurum, systemically healthy, 9 non-smokers, stage III B generalized periodontitis , 6 smokers (≥10/day), stage III C generalized periodontitis, 11 periodontally healthy non-smokers, and 11 periodontally healthy smokers were included. Clinical parameters of probing depth (PPD), clinical attachment level (CAL), plaque index (PI), and bleeding on probing (BOP) were recorded . All clinical measurements were made after saliva samples were taken and recorded as initial values. The periodontal index form was used for this purpose. (https://www.periodontalchart-online.com/uk/) Nonsurgical periodontal treatments lasted 4 weeks. Baseline and post-treatment periodontal parameters were compared.
1 secondary outcome
Salivary biomarkers
Time frame: up to 2 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 5 Feb 2025.
- Results publication: PubMed 12472994Mengel R, Bacher M, Flores-De-Jacoby L. Interactions between stress, interleukin-1beta, interleukin-6 and cortisol in periodontally diseased patients. J Clin Periodontol. 2002 Nov;29(11):1012-22. doi: 10.1034/j.1600-051x.2002.291106.x.
- Ethical approval was obtained from this related institution, as it used to be a clinical research board.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to share the saliva biomarker statistics of the study as an excel file when requested. Our Turkish study protocol has also received approval (ethics committee decision).
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Intervention, Saliva Collection (Baseline) and Probing in people with Saliva and Cortisol, run by Karabuk University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 7 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Study population, pre-treatment and post-treatment periodontal clinical parameters (time frame: up to 4 weeks). 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 NCT06809439, 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 5 Feb 2025.