PeriodontitisNCT07747545
Caffeine Intake and Periodontal Treatment Outcomes
A study testing No Caffeine Intake, Low Caffeine Intake and Moderate Caffeine Intake in people with Periodontitis, run by Haoran Feng at 1 site in China.
Trial summary
This study will explore whether caffeine intake can affect recovery after periodontal (gum) treatment. Periodontitis is a common gum disease caused by bacteria. Even after treatment, some people may still have ongoing inflammation or changes in oral bacteria. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- No Caffeine Intake, Low Caffeine Intake and Moderate Caffeine Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 55 years.
- Diagnosed with periodontitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions.
- First visit for periodontal treatment and eligible for standard non-surgical periodontal therapy.
- Willing and able to comply with the dietary intervention and scheduled follow-up visits.
- Able to understand the study procedures and provide written informed consent.
- Able to communicate effectively and complete study questionnaires and follow-up assessments.
Who cannot join
- Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- History of periodontal treatment within the previous 6 months.
- Current smokers or tobacco users.
- Use of antibiotics, anti-inflammatory drugs, immunosuppressive agents, or medications known to affect periodontal status within the previous 3 months.
- Presence of systemic diseases that may influence periodontal conditions, including diabetes mellitus, hypertension, or hyperlipidemia.
- Severe systemic diseases, psychiatric disorders, or other conditions that may interfere with study participation or protocol compliance.
- Allergy or intolerance to caffeine or inability to comply with the dietary caffeine intervention.
- Individuals with limited hand function or other conditions preventing adequate oral hygiene practices.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Stomatological Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Haoran Feng, BS, +86 13815309288, fenghaoran0611@gmail.com
Lei Wang, BS, +86 19961910284, 657952067@qq.com
About this study
Official title: Effects of Dietary Caffeine Intake on Periodontal Treatment Outcomes: A Randomized Controlled Trial
This study will explore whether caffeine intake can affect recovery after periodontal (gum) treatment.
Periodontitis is a common gum disease caused by bacteria. Even after treatment, some people may still have ongoing inflammation or changes in oral bacteria. Researchers want to know if daily caffeine intake, such as from coffee, may help improve this condition.
Read more
In this study, about 90 adults with periodontitis will receive standard periodontal treatment. Participants will be randomly assigned to one of three groups: no caffeine intake, low caffeine intake, or moderate caffeine intake. They will follow these instructions for about 6 months.
Researchers will collect saliva samples and check gum health at several time points after treatment. Saliva will be used to measure inflammation markers and to study changes in oral bacteria. Researchers will also record clinical gum conditions, such as gum pocket depth and bleeding.
The goal of this study is to understand whether caffeine intake can help reduce inflammation, improve oral bacteria balance, and support recovery after periodontal treatment. The results may help provide simple dietary advice to improve long-term gum health.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effects of dietary caffeine intake on periodontal treatment outcomes and potential biological mechanisms.
Periodontitis is a chronic inflammatory disease associated with microbial imbalance and increased inflammatory activity. Although standard periodontal treatment can control disease progression, some individuals may continue to experience persistent inflammation during the maintenance phase.
Approximately 90 adults with periodontitis will be recruited and will receive standard non-surgical periodontal treatment. Participants will be randomly assigned to one of three groups according to caffeine intake: no intake, low intake, and moderate intake.
Participants will be followed for 6 months. Saliva samples will be collected at baseline and multiple follow-up time points. These samples will be used to assess inflammatory biomarkers and oral microbiome characteristics. Clinical periodontal parameters will also be recorded during follow-up.
This study aims to evaluate whether dietary caffeine intake influences inflammatory responses, oral microbiome characteristics, and clinical periodontal outcomes after periodontal treatment. The findings may provide evidence for incorporating dietary factors into periodontal disease management.
- Conditions
- Periodontitis
- Being tested
- No Caffeine Intake, Low Caffeine Intake, Moderate Caffeine Intake
- Keywords
- Dietary caffeine, Caffeine intake, Non-surgical periodontal therapy, Oral microbiome, Salivary inflammatory biomarkers, Randomized controlled trial, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Caffeine IntakeDietary supplement
Participants will receive standard non-surgical periodontal treatment and will be instructed to avoid all dietary sources of caffeine throughout the 6-month study period.
Low Caffeine IntakeDietary supplement
Participants will receive standard non-surgical periodontal treatment and will consume approximately 50 mg of dietary caffeine per day throughout the 6-month study period.
Moderate Caffeine IntakeDietary supplement
Participants will receive standard non-surgical periodontal treatment and will consume approximately 100 mg of dietary caffeine per day throughout the 6-month study period.
| Study group | Role | What they receive |
|---|---|---|
| No Caffeine Intake Group | Experimental | Participants will receive standard non-surgical periodontal treatment and will be instructed to avoid dietary caffeine intake throughout the 6-month study period. Receives: Dietary Supplement: No Caffeine Intake |
| Low Caffeine Intake Group | Experimental | Participants will receive standard non-surgical periodontal treatment and will consume approximately 50 mg of dietary caffeine per day throughout the 6-month study period. Receives: Dietary Supplement: Low Caffeine Intake |
| Moderate Caffeine Intake Group | Experimental | Participants will receive standard non-surgical periodontal treatment and will consume approximately 100 mg of dietary caffeine per day throughout the 6-month study period. Receives: Dietary Supplement: Moderate Caffeine Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Unstimulated whole saliva will be collected at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. Salivary matrix metalloproteinase-8 concentration will be quantified using a commercial enzyme-linked immunosorbent assay kit. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Mean Change From Baseline in Salivary Interleukin-1 Beta Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Unstimulated whole saliva will be collected at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. Salivary interleukin-1 beta concentration will be quantified using a commercial enzyme-linked immunosorbent assay kit. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Secondary outcomes (6)
Mean Change From Baseline in Salivary Interleukin-6 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Unstimulated whole saliva will be collected at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. Salivary interleukin-6 concentration will be quantified using a commercial enzyme-linked immunosorbent assay kit. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Mean Change From Baseline in the Shannon Diversity Index of the Salivary Microbiome at 2 Weeks, 1 Month, 3 Months, and 6 Months
Salivary microbiome composition will be assessed using 16S ribosomal RNA gene sequencing. Alpha diversity will be quantified using the Shannon diversity index at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.
Mean Change From Baseline in the Relative Abundance of Porphyromonas gingivalis in Saliva at 2 Weeks, 1 Month, 3 Months, and 6 Months.
The relative abundance of Porphyromonas gingivalis in saliva will be estimated using 16S ribosomal RNA gene sequencing and reported as a percentage. For each participant, change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. The outcome will be summarized as the mean change in percentage points for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.
Mean Change From Baseline in Full-Mouth Mean Probing Depth at 2 Weeks, 1 Month, 3 Months, and 6 Months
Probing depth will be measured in millimeters by one trained and calibrated periodontal examiner using a Florida electronic periodontal probe at six sites per tooth. For each participant, full-mouth mean probing depth will be calculated across all examined periodontal sites at each assessment. Change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.
Mean Change From Baseline in Full-Mouth Mean Clinical Attachment Level at 2 Weeks, 1 Month, 3 Months, and 6 Months
Clinical attachment level will be measured in millimeters by one trained and calibrated periodontal examiner using a Florida electronic periodontal probe at six sites per tooth. For each participant, full-mouth mean clinical attachment level will be calculated across all examined periodontal sites at each assessment. Change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Mean Change From Baseline in the Percentage of Periodontal Sites With Bleeding on Probing at 2 Weeks, 1 Month, 3 Months, and 6 Months
Bleeding on probing will be assessed by one trained and calibrated periodontal examiner at six sites per tooth. For each participant, the percentage of periodontal sites with bleeding on probing will be calculated as the number of sites showing bleeding divided by the total number of sites examined, multiplied by 100. Change from baseline will be calculated separately at 2 weeks, 1 month, 3 months, and 6 months. The outcome will be summarized as the mean change in percentage points for each intervention arm at each time point.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: no caffeine intake, low caffeine intake (approximately 50 mg/day), or moderate caffeine intake (approximately 100 mg/day). Each participant will remain in the assigned group throughout the 6-month follow-up period.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haoran Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Stomatological Hospital of Xuzhou Medical University
- Responsible party
- Sponsor-investigator, Haoran Feng, Affiliated Stomatological Hospital of Xuzhou Medical University
- Investigators
- Haoran Feng, Principal investigator, Affiliated Stomatological Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747545
- Sponsor's protocol ID
- 2026-KY-008-02
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data used for the published results will be shared, including demographic information, periodontal clinical parameters, salivary inflammatory biomarker measurements (MMP-8, IL-1β, and IL-6), and oral microbiome sequencing data. The study protocol and statistical analysis plan will also be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Caffeine Intake on Periodontal Treatment Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07747545
- Acronym / sponsor ID
- 2026-KY-008-02
- Conditions
- Periodontitis
- Keywords
- Dietary caffeine, Caffeine intake, Non-surgical periodontal therapy, Oral microbiome, Salivary inflammatory biomarkers, Randomized controlled trial, Periodontitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Haoran FengUniversity, hospital or other
- Collaborators
- Affiliated Stomatological Hospital of Xuzhou Medical University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Aug 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.
This study will explore whether caffeine intake can affect recovery after periodontal (gum) treatment.
Periodontitis is a common gum disease caused by bacteria. Even after treatment, some people may still have ongoing inflammation or changes in oral bacteria. Researchers want to know if daily caffeine intake, such as from coffee, may help improve this condition.
In this study, about 90 adults with periodontitis will receive standard periodontal treatment. Participants will be randomly assigned to one of three groups: no caffeine intake, low caffeine intake, or moderate caffeine intake. They will follow these instructions for about 6 months.
Researchers will collect saliva samples and check gum health at several time points after treatment. Saliva will be used to measure inflammation markers and to study changes in oral bacteria. Researchers will also record clinical gum conditions, such as gum pocket depth and bleeding.
The goal of this study is to understand whether caffeine intake can help reduce inflammation, improve oral bacteria balance, and support recovery after periodontal treatment. The results may help provide simple dietary advice to improve long-term gum health.
Detailed description
This study is a randomized controlled trial designed to evaluate the effects of dietary caffeine intake on periodontal treatment outcomes and potential biological mechanisms.
Periodontitis is a chronic inflammatory disease associated with microbial imbalance and increased inflammatory activity. Although standard periodontal treatment can control disease progression, some individuals may continue to experience persistent inflammation during the maintenance phase.
Approximately 90 adults with periodontitis will be recruited and will receive standard non-surgical periodontal treatment. Participants will be randomly assigned to one of three groups according to caffeine intake: no intake, low intake, and moderate intake.
Participants will be followed for 6 months. Saliva samples will be collected at baseline and multiple follow-up time points. These samples will be used to assess inflammatory biomarkers and oral microbiome characteristics. Clinical periodontal parameters will also be recorded during follow-up.
This study aims to evaluate whether dietary caffeine intake influences inflammatory responses, oral microbiome characteristics, and clinical periodontal outcomes after periodontal treatment. The findings may provide evidence for incorporating dietary factors into periodontal disease management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: no caffeine intake, low caffeine intake (approximately 50 mg/day), or moderate caffeine intake (approximately 100 mg/day). Each participant will remain in the assigned group throughout the 6-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| No Caffeine Intake Group | Experimental | Dietary Supplement: No Caffeine IntakeParticipants will receive standard non-surgical periodontal treatment and will be instructed to avoid dietary caffeine intake throughout the 6-month study period. |
| Low Caffeine Intake Group | Experimental | Dietary Supplement: Low Caffeine IntakeParticipants will receive standard non-surgical periodontal treatment and will consume approximately 50 mg of dietary caffeine per day throughout the 6-month study period. |
| Moderate Caffeine Intake Group | Experimental | Dietary Supplement: Moderate Caffeine IntakeParticipants will receive standard non-surgical periodontal treatment and will consume approximately 100 mg of dietary caffeine per day throughout the 6-month study period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 55 years.
- Diagnosed with periodontitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions.
- First visit for periodontal treatment and eligible for standard non-surgical periodontal therapy.
- Willing and able to comply with the dietary intervention and scheduled follow-up visits.
- Able to understand the study procedures and provide written informed consent.
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- History of periodontal treatment within the previous 6 months.
- Current smokers or tobacco users.
- Use of antibiotics, anti-inflammatory drugs, immunosuppressive agents, or medications known to affect periodontal status within the previous 3 months.
- Presence of systemic diseases that may influence periodontal conditions, including diabetes mellitus, hypertension, or hyperlipidemia.
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 |
|---|---|---|
| No Caffeine IntakeParticipants will receive standard non-surgical periodontal treatment and will be instructed to avoid all dietary sources of caffeine throughout the 6-month study period. | Dietary supplement | No Caffeine Intake Group |
| Low Caffeine IntakeParticipants will receive standard non-surgical periodontal treatment and will consume approximately 50 mg of dietary caffeine per day throughout the 6-month study period. | Dietary supplement | Low Caffeine Intake Group |
| Moderate Caffeine IntakeParticipants will receive standard non-surgical periodontal treatment and will consume approximately 100 mg of dietary caffeine per day throughout the 6-month study period. | Dietary supplement | Moderate Caffeine Intake Group |
Primary outcome
Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Unstimulated whole saliva will be collected at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. Salivary matrix metalloproteinase-8 concentration will be quantified using a commercial enzyme-linked immunosorbent assay kit. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
Mean Change From Baseline in Salivary Interleukin-1 Beta Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Unstimulated whole saliva will be collected at baseline and at 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention. Salivary interleukin-1 beta concentration will be quantified using a commercial enzyme-linked immunosorbent assay kit. For each participant, change from baseline will be calculated separately at each post-baseline time point. The outcome will be summarized as the mean change from baseline for each intervention arm at each time point.
6 secondary outcomes
Mean Change From Baseline in Salivary Interleukin-6 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Mean Change From Baseline in the Shannon Diversity Index of the Salivary Microbiome at 2 Weeks, 1 Month, 3 Months, and 6 Months
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.
Mean Change From Baseline in the Relative Abundance of Porphyromonas gingivalis in Saliva at 2 Weeks, 1 Month, 3 Months, and 6 Months.
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.
Mean Change From Baseline in Full-Mouth Mean Probing Depth at 2 Weeks, 1 Month, 3 Months, and 6 Months
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention.
Mean Change From Baseline in Full-Mouth Mean Clinical Attachment Level at 2 Weeks, 1 Month, 3 Months, and 6 Months
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
Mean Change From Baseline in the Percentage of Periodontal Sites With Bleeding on Probing at 2 Weeks, 1 Month, 3 Months, and 6 Months
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data used for the published results will be shared, including demographic information, periodontal clinical parameters, salivary inflammatory biomarker measurements (MMP-8, IL-1β, and IL-6), and oral microbiome sequencing data. The study protocol and statistical analysis plan will also be available upon reasonable request.
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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.
Haoran Feng principal investigator
Affiliated Stomatological Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Caffeine Intake, Low Caffeine Intake and Moderate Caffeine Intake in people with Periodontitis, run by Haoran Feng at 1 site in China.
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 6 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 18 Aug 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 China. 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 Haoran Feng, BS (+86 13815309288, fenghaoran0611@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Salivary Matrix Metalloproteinase-8 Concentration at 2 Weeks, 1 Month, 3 Months, and 6 Months (time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after initiation of the intervention). 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?
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 18 Aug 2026.