Periodontal DiseasesNCT06753682
Healthy Plant-based Diet and Periodontal Treatment
A study testing Healthy Plant Based Diet in people with Periodontal Diseases and Periodontitis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Periodontitis is a highly prevalent chronic disease, affecting around 743 million people globally. In Hong Kong, over 90% of adults have bleeding gums, and 50% of the elderly have severe periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Diet
- What is being tested?
- Healthy Plant Based Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to 31 May 2026
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese ethnicity aged between 18 and 64;
- Generalized Stage II and Stage III periodontitis;
- at least 10 occluding pairs present;
- Good general health;
- Never-smoker or former smoker who had quit smoking successfully for at least 12 months prior to the screening visit;
- Body mass index (BMI) ranging between 18.5 and 28 kg/m2;
- Self-reported inadequacy of hPBD with the main focus on fresh vegetables (\<300 g/day) or/and fruit (\<200 g/day) with reference to the Dietary Guidelines for Chinese residents (Society, 2022).
Who cannot join
- Edentulism
- Presence of any systemic disease or taking medication that can alter the manifestation/outcome of periodontal treatment (e.g., uncontrolled diabetes mellitus, hypertension with use of calcium channel blocker, etc.)
- Pregnancy or intention to become pregnant at any point during the study duration
- Need for antibiotic prophylaxis in the context of dental treatment
- Having received non-steroidal anti-inflammatory medication or antibiotics within the previous 3 months
- Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
Show all 11Show fewer
- History or clinical manifestation of any eating disorder as determined the International Classification of Diseases
- Presence of any dietary restriction (e.g., adherence to a Mediterranean diet), currently taking nutrient supplements or inability to choose his/her diet
- Having obvious weight change (≥5% of current body weight) over the past 6 months
- Participation in another intervention trial
- Inability or unwillingness of individual to give written informed consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince Philip Dental Hospiral
Hong Kong, 00000
Ke Deng, 28590251, cdeng@hku.hk
Nichol Chun Wai Tsang, 91275616, nichol@connect.hku.hk
About this study
Official title: Effect of the Healthy Plant-based Dietary Pattern as an Adjunct to Non-surgical Periodontal Treatment in Periodontitis: A Randomized Controlled Clinical Trial
Background:
Periodontitis is a highly prevalent chronic disease, affecting around 743 million people globally. In Hong Kong, over 90% of adults have bleeding gums, and 50% of the elderly have severe periodontitis.
Read more
The causes of periodontitis are complex, involving polymicrobial dysbiosis, chronic inflammation, immune response, and environmental factors. Current treatments focus on oral hygiene, biofilm/calculus removal, and surgery for advanced cases. While lifestyle and risk factor modifications can improve treatment outcomes, only a few modifiable factors, like smoking cessation and diabetes control, have been established. Identifying more modifiable risk factors and implementing effective interventions are crucial to address this significant public health issue.
Diet has shown to be a major modifiable risk factors in pathophysiology of diabetes mellitus and cardiovascular diseases. The recent Global Burden of Diseases (GBD) study also supports this by pointing out the key dietary risk factors for chronic diseases and mortality. Nonetheless, the role of dietary intervention in the field of periodontitis is poorly understood.
The evidence of a plant-based dietary pattern, defined by a higher consumption of plant foods and lower intake of animal foods, on preventing and treating NCDs is emerging and a "healthy plant-based dietary pattern" is shown to lower risk of periodontitis and elevated serum antibody levels against periodontopathogens. "Healthful plant-based dietary pattern" mainly comprises of high consumption of healthy plant food (e.g., whole grains, fruit and vegetable), but low proportion intake of unhealthy plant food (e.g., refined grains, fruit juices, and sugar-sweetened beverages) .
Although the cross-sectional data from National Health and Nutrition Examination Survey (NHANES) shows promising benefits of the healthful plant-based diet, it is still inconclusive whether "healthful plant-based dietary pattern" is beneficial in preventing and treating periodontal disease. Therefore, it is planned to carry out a high quality, randomised controlled trial to support advocating this dietary pattern in periodontal patients.
Hypothesis:
It is hypothesized that non-surgical periodontal treatment (NSPT) performed in conjunction with healthful plant-based diet would provide additional clinical, immunological and microbiological benefits without incurring malnutrition periodontitis patients
Materials and Methods:
- Recruitment of subjects
- Patients diagnosed with Stage II and Stage III Periodontitis will be recruited from the Reception and Primary Care Clinic of the Prince Philip Dental Hospital and the Institute for Advanced Dentistry, The University of Hong Kong.
- Participants enrolled will be randomized into two groups, one test group and one control group (with or without dietary intervention on healthy plant-based diet)
- Study Procedures
- Baseline examination At baseline, besides the routine periodontal examination, patients will undergo dietary assessment by performing the Food Frequency Questionnaire (FFQ), anthropometric measures, oral health related quality of life and physical activity assessment . Biological samples for instance the blood, saliva, fecal and subgingival plaque will also be collected.
- Periodontal treatment Step I and Step II periodontal therapy including, oral hygiene instructions, control of risk factors, extraction of hopeless teeth, if any, scaling and root surface debridement will be provided to both groups
- Dietary intervention The participants in the test group will participate in a 3-month active intervention phase, a 3-month reinforcement phase, and a 6-month maintenance phase, with the intervention delivered by a trained and registered dietitian. The participants in the control group will continue the ad libitum diets based on their current eating habits and receive no dietary interventions..
- Recall Schedule The follow-up visits will be conducted at 2 weeks, 4 weeks, 3, 6 and 12 months after completion of the debridement.
Significance:
This study will provide local data and explore whether healthful plant-based diet as an adjunct to non-surgical periodontal treatment can improve clinical outcome, and provide scientific evidence of its effect on clinical, immunological and microbiological markers of periodontitis.
This can help us understand more on the relationship of healthful plant-based diet and periodontal diseases, which may eventually provide new perspectives for treatment of patients with periodontitis.
- Conditions
- Periodontal Diseases, Periodontitis, Diet
- Being tested
- Healthy Plant Based Diet
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Plant Based DietBehavioural
Registered Dietician will assist in modifying the patient's diet
| Study group | Role | What they receive |
|---|---|---|
| Healthy Plant Based Diet Group | Experimental | Participants will receive dietary intervention on top of non-surgical periodontal treatment Receives: Behavioral: Healthy Plant Based Diet |
| Control Group | No intervention | Participants will just receive non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Probing pocket depth (PPD) at 6 months after NSPT compared to baseline assessment
Measured: 6 months after NSPT
Secondary outcomes (7)
Changes of PPD at 3, 12 months after NSPT compared to baseline assessment
Measured: 3 months and 12 months
Changes of Clinical attachment level (CAL) assessed using periodontal probing method at 3, 6 and 12 months after NSPT compared to baseline assessment
Measured: 3, 6 and 12 months after NSPT
Changes of the percentage of Bleeding on probing (BOP) assessed using periodontal probing method compared to baseline assessment
Measured: 3, 6 and 12 months after NSPT
Changes in subgingival microbiome assessed using 16S rRNA Gene Sequencing at 3, 6 and 12 months after NSPT compared to baseline assessment
Measured: 3, 6 and 12 months after NSPT compared to baseline assessment
Changes in gut microbiome assessed using 16S rRNA Gene Sequencing at 3, 6 and 12 months after NSPT compared to baseline assessment
Measured: 3, 6 and 12 months after NSPT compared to baseline assessment
Changes in salivary and blood-based biomarker levels at 3, 6 and 12 months after NSPT compared to baseline assessment
Measured: 3, 6 and 12 months after NSPT compared to baseline assessment
Changes in healthful plant-based diet index (hPDI) with higher scores indicating a healthier diet at 3,6 and 12 months after NSPT compared to baseline assessment
Measured: 3,6 and 12 months after NSPT compared to baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Sep 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Deng Ke Coral, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753682
- Sponsor's protocol ID
- UW 24-003
- Status last verified
- Sep 2024
- First submitted
- 8 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li A, Qiu B, Goettsch M, Chen Y, Ge S, Xu S, Tjakkes GE. Association between the quality of plant-based diets and periodontitis in the U.S. general population. J Clin Periodontol. 2023 May;50(5):591-603. doi: 10.1111/jcpe.13785. Epub 2023 Feb 13.
PubMed 36734066Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
PubMed 25261053Craig WJ, Mangels AR, Fresan U, Marsh K, Miles FL, Saunders AV, Haddad EH, Heskey CE, Johnston P, Larson-Meyer E, Orlich M. The Safe and Effective Use of Plant-Based Diets with Guidelines for Health Professionals. Nutrients. 2021 Nov 19;13(11):4144. doi: 10.3390/nu13114144.
PubMed 34836399Satija A, Bhupathiraju SN, Rimm EB, Spiegelman D, Chiuve SE, Borgi L, Willett WC, Manson JE, Sun Q, Hu FB. Plant-Based Dietary Patterns and Incidence of Type 2 Diabetes in US Men and Women: Results from Three Prospective Cohort Studies. PLoS Med. 2016 Jun 14;13(6):e1002039. doi: 10.1371/journal.pmed.1002039. eCollection 2016 Jun.
PubMed 27299701Sanz 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 32383274Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PubMed 29926952
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Healthy Plant-based Dietary Pattern as an Adjunct to Non-surgical Periodontal Treatment in Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06753682
- Acronym / sponsor ID
- UW 24-003
- Conditions
- Periodontal Diseases, Periodontitis, Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 31 Dec 2024 (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.
Background:
Periodontitis is a highly prevalent chronic disease, affecting around 743 million people globally. In Hong Kong, over 90% of adults have bleeding gums, and 50% of the elderly have severe periodontitis.
The causes of periodontitis are complex, involving polymicrobial dysbiosis, chronic inflammation, immune response, and environmental factors. Current treatments focus on oral hygiene, biofilm/calculus removal, and surgery for advanced cases. While lifestyle and risk factor modifications can improve treatment outcomes, only a few modifiable factors, like smoking cessation and diabetes control, have been established. Identifying more modifiable risk factors and implementing effective interventions are crucial to address this significant public health issue.
Diet has shown to be a major modifiable risk factors in pathophysiology of diabetes mellitus and cardiovascular diseases. The recent Global Burden of Diseases (GBD) study also supports this by pointing out the key dietary risk factors for chronic diseases and mortality. Nonetheless, the role of dietary intervention in the field of periodontitis is poorly understood.
The evidence of a plant-based dietary pattern, defined by a higher consumption of plant foods and lower intake of animal foods, on preventing and treating NCDs is emerging and a "healthy plant-based dietary pattern" is shown to lower risk of periodontitis and elevated serum antibody levels against periodontopathogens. "Healthful plant-based dietary pattern" mainly comprises of high consumption of healthy plant food (e.g., whole grains, fruit and vegetable), but low proportion intake of unhealthy plant food (e.g., refined grains, fruit juices, and sugar-sweetened beverages) .
Although the cross-sectional data from National Health and Nutrition Examination Survey (NHANES) shows promising benefits of the healthful plant-based diet, it is still inconclusive whether "healthful plant-based dietary pattern" is beneficial in preventing and treating periodontal disease. Therefore, it is planned to carry out a high quality, randomised controlled trial to support advocating this dietary pattern in periodontal patients.
Hypothesis:
It is hypothesized that non-surgical periodontal treatment (NSPT) performed in conjunction with healthful plant-based diet would provide additional clinical, immunological and microbiological benefits without incurring malnutrition periodontitis patients
Materials and Methods:
- Recruitment of subjects
- Patients diagnosed with Stage II and Stage III Periodontitis will be recruited from the Reception and Primary Care Clinic of the Prince Philip Dental Hospital and the Institute for Advanced Dentistry, The University of Hong Kong.
- Participants enrolled will be randomized into two groups, one test group and one control group (with or without dietary intervention on healthy plant-based diet)
- Study Procedures
- Baseline examination At baseline, besides the routine periodontal examination, patients will undergo dietary assessment by performing the Food Frequency Questionnaire (FFQ), anthropometric measures, oral health related quality of life and physical activity assessment . Biological samples for instance the blood, saliva, fecal and subgingival plaque will also be collected.
- Periodontal treatment Step I and Step II periodontal therapy including, oral hygiene instructions, control of risk factors, extraction of hopeless teeth, if any, scaling and root surface debridement will be provided to both groups
- Dietary intervention The participants in the test group will participate in a 3-month active intervention phase, a 3-month reinforcement phase, and a 6-month maintenance phase, with the intervention delivered by a trained and registered dietitian. The participants in the control group will continue the ad libitum diets based on their current eating habits and receive no dietary interventions..
- Recall Schedule The follow-up visits will be conducted at 2 weeks, 4 weeks, 3, 6 and 12 months after completion of the debridement.
Significance:
This study will provide local data and explore whether healthful plant-based diet as an adjunct to non-surgical periodontal treatment can improve clinical outcome, and provide scientific evidence of its effect on clinical, immunological and microbiological markers of periodontitis.
This can help us understand more on the relationship of healthful plant-based diet and periodontal diseases, which may eventually provide new perspectives for treatment of patients with periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Plant Based Diet Group | Experimental | Behavioral: Healthy Plant Based DietParticipants will receive dietary intervention on top of non-surgical periodontal treatment |
| Control Group | No intervention | –Participants will just receive non-surgical periodontal treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chinese ethnicity aged between 18 and 64;
- Generalized Stage II and Stage III periodontitis;
- at least 10 occluding pairs present;
- Good general health;
- Never-smoker or former smoker who had quit smoking successfully for at least 12 months prior to the screening visit;
Key exclusion criteria (11 listed)
- Edentulism
- Presence of any systemic disease or taking medication that can alter the manifestation/outcome of periodontal treatment (e.g., uncontrolled diabetes mellitus, hypertension with use of calcium channel blocker, etc.)
- Pregnancy or intention to become pregnant at any point during the study duration
- Need for antibiotic prophylaxis in the context of dental treatment
- Having received non-steroidal anti-inflammatory medication or antibiotics within the previous 3 months
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 |
|---|---|---|
| Healthy Plant Based DietRegistered Dietician will assist in modifying the patient's diet | Behavioural | Healthy Plant Based Diet Group |
Primary outcome
Changes of Probing pocket depth (PPD) at 6 months after NSPT compared to baseline assessment
Time frame: 6 months after NSPT
7 secondary outcomes
Changes of PPD at 3, 12 months after NSPT compared to baseline assessment
Time frame: 3 months and 12 months
Changes of Clinical attachment level (CAL) assessed using periodontal probing method at 3, 6 and 12 months after NSPT compared to baseline assessment
Time frame: 3, 6 and 12 months after NSPT
Changes of the percentage of Bleeding on probing (BOP) assessed using periodontal probing method compared to baseline assessment
Time frame: 3, 6 and 12 months after NSPT
Changes in subgingival microbiome assessed using 16S rRNA Gene Sequencing at 3, 6 and 12 months after NSPT compared to baseline assessment
Time frame: 3, 6 and 12 months after NSPT compared to baseline assessment
Changes in gut microbiome assessed using 16S rRNA Gene Sequencing at 3, 6 and 12 months after NSPT compared to baseline assessment
Time frame: 3, 6 and 12 months after NSPT compared to baseline assessment
Changes in salivary and blood-based biomarker levels at 3, 6 and 12 months after NSPT compared to baseline assessment
Time frame: 3, 6 and 12 months after NSPT compared to baseline assessment
Changes in healthful plant-based diet index (hPDI) with higher scores indicating a healthier diet at 3,6 and 12 months after NSPT compared to baseline assessment
Time frame: 3,6 and 12 months after NSPT compared to baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Results publication: PubMed 36734066Li A, Qiu B, Goettsch M, Chen Y, Ge S, Xu S, Tjakkes GE. Association between the quality of plant-based diets and periodontitis in the U.S. general population. J Clin Periodontol. 2023 May;50(5):591-603. doi: 10.1111/jcpe.13785. Epub 2023 Feb 13.
- Results publication: PubMed 25261053Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
- Results publication: PubMed 34836399Craig WJ, Mangels AR, Fresan U, Marsh K, Miles FL, Saunders AV, Haddad EH, Heskey CE, Johnston P, Larson-Meyer E, Orlich M. The Safe and Effective Use of Plant-Based Diets with Guidelines for Health Professionals. Nutrients. 2021 Nov 19;13(11):4144. doi: 10.3390/nu13114144.
- Results publication: PubMed 27299701Satija A, Bhupathiraju SN, Rimm EB, Spiegelman D, Chiuve SE, Borgi L, Willett WC, Manson JE, Sun Q, Hu FB. Plant-Based Dietary Patterns and Incidence of Type 2 Diabetes in US Men and Women: Results from Three Prospective Cohort Studies. PLoS Med. 2016 Jun 14;13(6):e1002039. doi: 10.1371/journal.pmed.1002039. eCollection 2016 Jun.
- 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 29926952Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Plant Based Diet in people with Periodontal Diseases and Periodontitis, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Dec 2024. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Deng (312-785-8853, cdeng@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Probing pocket depth (PPD) at 6 months after NSPT compared to baseline assessment (time frame: 6 months after NSPT). 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 NCT06753682, which also lists 6 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 31 Dec 2024.