GingivitisSPANCT06671106
Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents.
A study testing toothbrushing, flossing and Toothpaste Product in people with Gingivitis, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate if the adjunctive use of an amine and zinc lactate - containing mouthrinse may give significant benefits in the home-based treatment of plaque-induced gingivitis in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- toothbrushing, flossing and Toothpaste Product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to 31 Dec 2026
- 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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- systemically healthy;
- eligible for oral care provision by Regional Health Service due to low socio-economic status;
- at least 16 fully erupted teeth (excluding third molars);
- diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018, Chapple et al. 2018);
- willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and filling).
Who cannot join
- pregnant or lactating;
- current smoking;
- motor and/or cognitive deficit impairing compliance with the study intervals or procedures;
- legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;
- teeth with developmental defects (e.g., enamel pearls/projections);
- untreated oral lesions, including dental caries or endodontic lesions;
Show all 10Show fewer
- fixed or removable orthodontic appliances or scheduled for orthodontic therapy with a timing not compatible with the experimental phase;
- use of antibiotics in the previous 3 months;
- use of medications that affect the size of the gingival tissues, such as phenytoin, sodium valproate, certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), and immune-regulating drugs (e.g., cyclosporine);
- conditions (e.g., Sjögren's syndrome, anxiety, poorly controlled diabetes) or medications (e.g., antihistamines, decongestants, antidepressants) that are associated with hyposalivation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents. A Single-center, Examiner-blind, Parallel-arm, Randomized Trial
The goal of this clinical trial is to evaluate if the adjunctive use of an amine and zinc lactate - containing mouthrinse may give significant benefits in the home-based treatment of plaque-induced gingivitis in adolescents. The study is based on the following hypothesis: the periodontal conditions of participants affected by gingivitis will significantly benefit from the implementation of the self-performed plaque control regimen (consisting of manual toothbrush and amine and zinc lactate toothpaste) with an amine and zinc lactate - containing mouthrinse. The benefit is expected to become manifest in terms of impact on clinical periodontal parameters, ecology of the subgingival environment, patient-reported outcomes and oral-health-related quality of life. In other words, gingivitis participants implementing their self-performed oral hygiene with the investigated mouthrinse are expected to assume a closer profile (based on the outcomes listed above) to periodontally healthy subjects when compared to gingivitis participants not using the investigated mouthrinse.
One hundred fifty participants (100 adolescents with gingivitis and 50 periodontally healthy adolescents) will be selected for the study. Gingivitis patients will be asked to participate in 5 observation intervals: screening visit, study baseline, and 3 follow-up visits (3 weeks, 3 months, 6 months), while periodontally healthy controls will conclude their participation in the study within the baseline visit.
Read more
According to the randomization list, at baseline gingivitis patients will receive one of the following home-based oral hygiene regimen:
- test intervention (Gt group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection);
- control intervention (Gc group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection); All periodontally healthy subjects will be assigned control intervention.
At baseline, both gingivitis patients and periodontally healthy subjects will undergo:
- assessment of clinical periodontal parameters;
- subgingival plaque sampling for microbiological analysis;
- assessment of patient-reported outcomes (including oral-health related quality of life) using dedicated questionnaires; Gingivitis subjects will repeat the assessments at 3-week, 3-month, and 6-month follow-up visit.
The 6-month proportion of periodontally healthy participants in each gingivitis group (Gt and Gc) will be regarded as the primary outcome of the study. Changes in clinical parameters, subgingival microbial community profile, and scores related to patient-reported outcomes will be regarded as the secondary outcome measures.
- Conditions
- Gingivitis
- Being tested
- toothbrushing, flossing, Toothpaste Product, Mouthrinse
- Keywords
- mouthrinse, plaque-induced gingivitis, adolescents, oral hygiene, amine lactate, zinc lactate, gingival inflammation, periodontal diseases
- Medical subject headings
- Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toothbrushingOther
manual toothbrush (meridol)
flossingOther
dental floss (meridol)
Toothpaste ProductDevice
amine and zinc lactate - containing toothpaste (meridol Gum Protection)
MouthrinseDevice
amine and zinc lactate - containing mouthrinse (meridol Gum Protection)
| Study group | Role | What they receive |
|---|---|---|
| Gingivitis - test intervention | Experimental | Gingivitis patients assigned to test intervention will use: manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection) Receives: Other: toothbrushing; Other: flossing; Device: Toothpaste Product; Device: Mouthrinse |
| Gingivitis - control intervention | Active comparator | Gingivitis patients assigned to control intervention will use: manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) Receives: Other: toothbrushing; Other: flossing; Device: Toothpaste Product |
| Periodontal health - no treatment | Other | Periodontally healthy subjects will be compared for baseline assessments with gingivitis patients of the other two arms. However, periodontally subjects will conclude their participation in the study within the baseline visit after receiving devices and instructions related to the control intervention. Receives: Other: toothbrushing; Other: flossing; Device: Toothpaste Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month proportion of periodontally healthy participants
At 6 months, the proportion (range: 0%-100%) of cases of periodontal health (as diagnosed according to the case definition of the 2017 World Workshop) will be evaluated and compared between Gt and Gc groups.
Measured: 6 months
Secondary outcomes (9)
Gingival Index (GI)
GI (without the BoP component) will be assessed on a scale from 0 (no clinically detectable inflammation) to 3 (severe inflammation with spontaneous bleeding) at the mesio-buccal aspects of 6 index teeth (i.e., 1.6, 2.1, 2.4, 3.6, 4.1, 4.4).
Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in Gi.
Measured: 3 weeks, 3 months, 6 months
Plaque score
Plaque score will be evaluated as present (0) or absent (1) at 6 sites (mesio-buccal, buccal, disto- buccal, mesio-lingual, lingual, disto-lingual) of each tooth.
Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in the full-mouth proportion of sites with plaque.
Measured: 3 weeks, 3 months, 6 months
Bleeding on probing (BoP)
BoP will be evaluated as present/absent using a UNC15 probe (Hu-Friedy Italy s.r.l., Milano, Italy) at 6 sites (mesio-buccal, buccal, disto-buccal, mesio- lingual, lingual, disto-lingual) of each tooth.
Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in the full-mouth prevalence of BoP (range: 0%-100%).
Measured: 3 weeks, 3 months, 6 months
Probing depth (PD)
PD will be measured in mm using a UNC15 probe (Hu-Friedy Italy s.r.l., Milano, Italy) at 6 sites (mesio-buccal, buccal, disto-buccal, mesio- lingual, lingual, disto-lingual) of each tooth.
Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in PD.
Measured: 3 weeks, 3 months, 6 months
Clinical attachment level (CAL)
CAL will be measured in mm using a UNC15 probe (Hu-Friedy Italy s.r.l., Milano, Italy) at 6 sites (mesio-buccal, buccal, disto-buccal, mesio- lingual, lingual, disto-lingual) of each tooth.
Gt and Gc groups will be compared for the 3-week, 3-month and 6-month changes in CAL.
Measured: 3 weeks, 3 months, 6 months
Plaque sampling and microbiological analysis
Plaque sampling will be performed with sterile Mini Five Gracey curettes (Hu-Friedy Italy s.r.l., Milano, Italy) from the subgingival area at the mesio- buccal aspects of 6 index teeth (Manual of Procedures for Human Microbiome Project - Core Microbiome Sampling Protocol Version Number: 12.0; 29 Jul 2010).
The microbial composition of each sample will be analyzed by a real-time quantitative PCR (qPCR) microarray, providing profiling of microorganisms usually found in dental plaque (Microbial DNA qPCR Array for Oral Disease) (Qiagen, Hilden, Germany). Array assays are designed using the 16S rRNA gene as the target gene and individual primers and hydrolysis-probe detection, increasing specificity of each assay. Amplification will be carried out in a Quant Studio 5 thermocycler (Thermo Fisher Scientific, Milan, Italy), providing simultaneous detection and quantification of 93 different microbial species, including putative and known periodontopathogens.
Measured: 3 weeks, 3 months, 6 months
Patient satisfaction with the use of the oral hygiene regimen
At 6 months, the participant will be asked to state his/her degree of satisfaction with the use of the oral hygiene regimen used during the experimental phase. Satisfaction will be classified as follows: 0- excellent; 1-good; 2- acceptable; 3- poor. The participant will also be asked about possible side effects and complaints related to the use of the assigned products. This evaluation will be performed without the presence of the examiners to enable the participant to give his/her honest opinion.
Measured: 6 months
Oral-health related quality of life (OHrQoL)
At baseline and 6 months, participants will be instructed to fill the Child Perceptions Questionnaire for 11- to 14 year-old Children (CPQ11-14). The questionnaire will be filled by the participant under the supervision of the examiner.
The assessment is developed through 37 questions distributed in 4 sections, which refer to: oral symptoms, functional limitations, emotions related to the condition of the oral cavity, and what role this has in social relationships. Each question will be rated according to the following scale: never (0); once or twice (1); sometimes (2); often (3); every day or almost every day (4).
The total score will be obtained as the algebraic sum of the single scores, and will range from 0 (indicating no impact of the oral health condition on the quality of life) to 148 (indicating maximum impact of the oral condition on the quality of life).
Measured: Baseline, 6 months
Adverse events (AEs)
Adverse events will be recorded on a dedicated form, and major adverse events will be immediately communicated to the Operative Unite of Legal Medicine, University - Hospital of Ferrara, Italy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start7 Jan 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- Single center, examiner-blind, parallel-arm, randomized trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Consorzio Futuro in Ricerca
- Responsible party
- Principal investigator, Leonardo Trombelli, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671106
- Sponsor's protocol ID
- 297-2024-Sper-AUSLFe
- Acronym
- SPA
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Biological samples (subgingival plaque) will be analyzed at the Section of Microbiology, University of Ferrara, Italy. However, the analysis will be conducted in a blinded fashion (no information related to patient identity and observation interval will be provided for each sample to be analyzed).
Publications
Montesani L, Montesani L, Mateo L, Daep C, Huber N, Isapour G, Zhang YP. Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial. Clin Oral Investig. 2024 Jan 13;28(1):90. doi: 10.1007/s00784-023-05487-0.
PubMed 38217757Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Clin Periodontol. 2018 Jun;45 Suppl 20:S44-S67. doi: 10.1111/jcpe.12939.
PubMed 29926492
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Amine and Zinc Lactate - Containing Mouthrinse in the Home-based Treatment of Plaque-induced Gingivitis in Adolescents. A Single-center, Examiner-blind, Parallel-arm, Randomized Trial
- ClinicalTrials.gov ID
- NCT06671106
- Acronym / sponsor ID
- SPA / 297-2024-Sper-AUSLFe
- Conditions
- Gingivitis
- Keywords
- mouthrinse, plaque-induced gingivitis, adolescents, oral hygiene, amine lactate, zinc lactate, gingival inflammation, periodontal diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- Consorzio Futuro in Ricerca
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 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.
The goal of this clinical trial is to evaluate if the adjunctive use of an amine and zinc lactate - containing mouthrinse may give significant benefits in the home-based treatment of plaque-induced gingivitis in adolescents. The study is based on the following hypothesis: the periodontal conditions of participants affected by gingivitis will significantly benefit from the implementation of the self-performed plaque control regimen (consisting of manual toothbrush and amine and zinc lactate toothpaste) with an amine and zinc lactate - containing mouthrinse. The benefit is expected to become manifest in terms of impact on clinical periodontal parameters, ecology of the subgingival environment, patient-reported outcomes and oral-health-related quality of life. In other words, gingivitis participants implementing their self-performed oral hygiene with the investigated mouthrinse are expected to assume a closer profile (based on the outcomes listed above) to periodontally healthy subjects when compared to gingivitis participants not using the investigated mouthrinse.
One hundred fifty participants (100 adolescents with gingivitis and 50 periodontally healthy adolescents) will be selected for the study. Gingivitis patients will be asked to participate in 5 observation intervals: screening visit, study baseline, and 3 follow-up visits (3 weeks, 3 months, 6 months), while periodontally healthy controls will conclude their participation in the study within the baseline visit.
According to the randomization list, at baseline gingivitis patients will receive one of the following home-based oral hygiene regimen:
- test intervention (Gt group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection);
- control intervention (Gc group): manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection); All periodontally healthy subjects will be assigned control intervention.
At baseline, both gingivitis patients and periodontally healthy subjects will undergo:
- assessment of clinical periodontal parameters;
- subgingival plaque sampling for microbiological analysis;
- assessment of patient-reported outcomes (including oral-health related quality of life) using dedicated questionnaires; Gingivitis subjects will repeat the assessments at 3-week, 3-month, and 6-month follow-up visit.
The 6-month proportion of periodontally healthy participants in each gingivitis group (Gt and Gc) will be regarded as the primary outcome of the study. Changes in clinical parameters, subgingival microbial community profile, and scores related to patient-reported outcomes will be regarded as the secondary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single center, examiner-blind, parallel-arm, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Gingivitis - test intervention | Experimental | Other: toothbrushing, Other: flossing, Device: Toothpaste Product, Device: MouthrinseGingivitis patients assigned to test intervention will use: manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) and amine and zinc lactate - containing mouthrinse (meridol Gum Protection) |
| Gingivitis - control intervention | Active comparator | Other: toothbrushing, Other: flossing, Device: Toothpaste ProductGingivitis patients assigned to control intervention will use: manual toothbrush (meridol) and dental floss (meridol) associated with amine and zinc lactate - containing toothpaste (meridol Gum Protection) |
| Periodontal health - no treatment | Other | Other: toothbrushing, Other: flossing, Device: Toothpaste ProductPeriodontally healthy subjects will be compared for baseline assessments with gingivitis patients of the other two arms. However, periodontally subjects will conclude their participation in the study within the baseline visit after receiving devices and instructions related to the control intervention. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- systemically healthy;
- eligible for oral care provision by Regional Health Service due to low socio-economic status;
- at least 16 fully erupted teeth (excluding third molars);
- diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018, Chapple et al. 2018);
- willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and filling).
Key exclusion criteria (10 listed)
- pregnant or lactating;
- current smoking;
- motor and/or cognitive deficit impairing compliance with the study intervals or procedures;
- legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;
- teeth with developmental defects (e.g., enamel pearls/projections);
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 |
|---|---|---|
| toothbrushingmanual toothbrush (meridol) | Other | Gingivitis - control intervention, Gingivitis - test intervention, Periodontal health - no treatment |
| flossingdental floss (meridol) | Other | Gingivitis - control intervention, Gingivitis - test intervention, Periodontal health - no treatment |
| Toothpaste Productamine and zinc lactate - containing toothpaste (meridol Gum Protection) | Device | Gingivitis - control intervention, Gingivitis - test intervention, Periodontal health - no treatment |
| Mouthrinseamine and zinc lactate - containing mouthrinse (meridol Gum Protection) | Device | Gingivitis - test intervention |
Primary outcome
6-month proportion of periodontally healthy participants
Time frame: 6 months
At 6 months, the proportion (range: 0%-100%) of cases of periodontal health (as diagnosed according to the case definition of the 2017 World Workshop) will be evaluated and compared between Gt and Gc groups.
9 secondary outcomes
Gingival Index (GI)
Time frame: 3 weeks, 3 months, 6 months
Plaque score
Time frame: 3 weeks, 3 months, 6 months
Bleeding on probing (BoP)
Time frame: 3 weeks, 3 months, 6 months
Probing depth (PD)
Time frame: 3 weeks, 3 months, 6 months
Clinical attachment level (CAL)
Time frame: 3 weeks, 3 months, 6 months
Plaque sampling and microbiological analysis
Time frame: 3 weeks, 3 months, 6 months
Patient satisfaction with the use of the oral hygiene regimen
Time frame: 6 months
Oral-health related quality of life (OHrQoL)
Time frame: Baseline, 6 months
Adverse events (AEs)
Time frame: 6 months
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 25 Mar 2025.
- Background: PubMed 38217757Montesani L, Montesani L, Mateo L, Daep C, Huber N, Isapour G, Zhang YP. Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial. Clin Oral Investig. 2024 Jan 13;28(1):90. doi: 10.1007/s00784-023-05487-0.
- Background: PubMed 29926492Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Clin Periodontol. 2018 Jun;45 Suppl 20:S44-S67. doi: 10.1111/jcpe.12939.
- Individual participant dataSharing planned: No. Biological samples (subgingival plaque) will be analyzed at the Section of Microbiology, University of Ferrara, Italy. However, the analysis will be conducted in a blinded fashion (no information related to patient identity and observation interval will be provided for each sample to be analyzed).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing toothbrushing, flossing and Toothpaste Product in people with Gingivitis, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 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 25 Mar 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 Italy. 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 Leonardo Trombelli, Full Professor and Director (+390532688507, leonardo.trombelli@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month proportion of periodontally healthy participants (time frame: 6 months). 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 NCT06671106, which also lists 2 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 25 Mar 2025.