Bone LossPhase 4BTCPNCT06935747
Osteogenic Action of a Medical Device Based on Beta-tricalcium Phosphate (BTCP)
A Phase 4 study testing Medical device: beta-tricalcium phosphate and Bovine Hydroxyapatite in people with Bone Loss and Regenerative Inflammation, run by Mario Pérez Sayáns at 2 sites in Spain.
Trial summary
The general objective of this split-mouth study is to analyze the osteogenic action of BTCP during the bone regeneration process following the extraction of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Regenerative Inflammation, Third Molars Extraction
- What is being tested?
- Medical device: beta-tricalcium phosphate and Bovine Hydroxyapatite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Jul 2025to Jul 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be of legal age, generally defined as 18 years or older, to be able to provide adequate informed consent and understand the risks and benefits of the procedure.
- Informed Consent: Patients must be willing to provide written informed consent to participate in the study, indicating their understanding and acceptance of the associated procedures and risks.
- Need for Extraction of Impacted Mandibular Third Molars: Patients must require the extraction of both impacted mandibular third molars to be eligible for the study.
- Similar Complexity of Impacted Third Molars: The impacted mandibular third molars must present similar complexity for extraction on both sides of the jaw, to ensure a fair comparison between the study groups.
- Absence of Medical Contraindications for Oral Surgical Procedures: Patients must not have significant medical contraindications that would prevent oral surgical procedures, such as clotting disorders, uncontrolled systemic diseases, or a history of severe infections.
Who cannot join
- Severe Mental Disorders: Patients with severe mental disorders that may affect their ability to understand and follow study instructions may be excluded due to concerns about their capacity to provide valid informed consent and follow the study protocol.
- Contraindications for Dental Extractions: Patients with specific contraindications for dental extraction, such as a history of osteonecrosis of the jaws or serious complications associated with previous dental procedures, may be excluded for safety reasons.
- Patients under the age of 18 will not be eligible to participate in the study due to ethical and legal concerns related to obtaining informed consent and the ability to understand the risks and benefits of the study.
- Withdrawal from the Study:
- -If a patient experiences severe complications during the study, such as severe postoperative infections, severe allergic reactions, or any other adverse event that may jeopardize their health, they will be considered for withdrawal from the study to ensure their well-being. Additionally, if a patient decides to voluntarily withdraw from the study at any time, their decision will be respected, and appropriate medical care will be provided as needed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
University of Murcia
Murcia, Murcia
Fabio Camacho Alonso
Universidade de Santiago de Compostela
Santiago de Compostela, A Coruña, 15705
Mario Pérez-Sayáns, PHD,PHD, mario.perez@usc.es
About this study
Official title: Clinical Study to Analyze the Osteogenic Action of a Beta-tricalcium Phosphate-based Product in Bone Regeneration After the Extraction of Impacted Mandibular Third Molars.
The general objective of this split-mouth study is to analyze the osteogenic action of BTCP during the bone regeneration process following the extraction of impacted mandibular third molars.
Read the detailed description
The proposed protocol is a multicenter clinical trial aimed at analyzing the osteogenic action of a medical device based on beta-tricalcium phosphate (hereinafter BTCP) in the bone regeneration process following the extraction of impacted mandibular third molars. The specific objectives of the study include a comparative analysis of clinical and radiological variables between a control group and a study group.
Inclusion criteria for study subjects include being of legal age, providing informed consent, and requiring the extraction of both impacted mandibular third molars, among others. Exclusion criteria include the presence of severe mental disorders or medical contraindications for tooth extraction.
The study involves a total of 60 third molars from 30 patients, divided into a control group and a study group. Data will be collected regarding patient demographics, the surgical procedure, and the bone regeneration assessment.
The surgical procedure involves selecting patients with similarly complex third molars, followed by tooth extraction and the placement of BTCP in the study group or a standard material in the control group. Clinical follow-up will be conducted during the first 7 days, and radiological follow-up will take place over the following 6 months to evaluate bone regeneration.
Patients will receive compensation for their participation in the study, which includes medical consultations, phone follow-ups, examination time, completion of questionnaires, and training in self-assessment.
- Being tested
- Medical device: beta-tricalcium phosphate, Bovine Hydroxyapatite
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical device: beta-tricalcium phosphateCombination product
The description of the intervention for BTCP in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. BTCP is indicated for the treatment of segmental and cavitary bone loss, aesthetic repairs, and bone augmentations (such as inlay or onlay grafts); for filling dental alveolar bone; for dental implant placement; and for the stabilization of osteotomies and prostheses in dentistry.
Bovine HydroxyapatiteOther
The intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties.
| Study group | Role | What they receive |
|---|---|---|
| BTCP Group | Experimental | The experimental BTCP group includes participants who will receive BTCP after the extraction of an impacted mandibular third molar to test its osteogenic properties. BTCP is prepared according to the manufacturer's instructions, initially by immersing it in sterile saline solution. It is applied to the socket after extraction using specialized instruments and is compared with a control group that receives Bio-Oss, a standard xenograft material.
Patients in the experimental group receive postoperative medication, including antibiotics and pain management treatment. Follow-up evaluations assess pain, inflammation, complications, and bone regeneration through radiological assessment.
Objective: To evaluate the efficacy of BTCP in bone regeneration compared to the control. Receives: Combination Product: Medical device: beta-tricalcium phosphate |
| Control group | Active comparator | The control group serves as the active comparator to the BTCP experimental group in this study. Participants undergo the same impacted mandibular third molar extraction procedures as those in the experimental group, but receive a standard material, Bio-Oss, instead of BTCP.
Bio-Oss, a widely used xenograft material in dental surgeries, serves as the reference due to its osteoconductive properties. It is applied to the socket after extraction using specialized instruments and acts as a benchmark for comparing the efficacy of BTCP. Patients in the control group receive postoperative medication according to the study protocol, including antibiotics and pain management treatment. Follow-up assessments evaluate pain, inflammation, complications, and bone regeneration through radiological evaluation. Receives: Other: Bovine Hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Regeneration_Reduction in radiolucent volume
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Reduction in radiolucent volume within the extraction socket, indicating new bone formation (Hounsfield unit (HU)). High values mean more radiopacity and better regeneration.
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Bone Regeneration_bone volume
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone volume within the extraction site over time (mm3). The increase in bone volume means better regeneration
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Bone Regeneration_bone density
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Changes in bone density within the regenerated bone tissue (Hounsfield unit (HU)) High values mean more radiopacity and better regeneration.
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Bone Regeneration_Fractal dimension
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone morphology within the extraction site over time analyzing the fractal dimension (FD) FD can vary between 1 and 2, with 1 being a very simple fractal dimension (such as a straight line) and 2 being a more complex fractal dimension (such as a completely irregular surface)
Measured: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Secondary outcomes (5)
Pain levels through visual analog scale
Assessment of pain experienced by participants using a visual analog scale (VAS) at various time points post-extraction. It comprehends values between 0-10, where 10 is the worst situation.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Clinical Inflammation evaluating by presence/absence
Evaluation of postoperative inflammation around the extraction site using clinical examination and assessment tools (presence/absence). The presence of inflammation means the worst prognosis.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Healing measured by healing index
The healing progress will be assessed using the Healing Index (HI) developed by Hamzani \& Chaushu (2018) and Landry (1988). The HI score ranges from 0 to 5, where 0 indicates poor healing and 5 indicates excellent healing. To ensure consistency and reliability in the assessment of healing, two independent researchers will evaluate the healing progress for all participants. The level of agreement between the researchers will be assessed using Cohen's Kappa index (Mandrekar, 2011). A Cohen's Kappa index value of 0.91 was achieved for the assessment of inflammation level, indicating a high degree of agreement. Similarly, agreement levels exceeding 0.90 were obtained across all HI levels, demonstrating a high level of concordance in the assessment of healing progress.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Post-surgical complications evaluated by presence or absense
Monitoring and recording of any complications following the extraction procedure, such as alveolitis, trismus, infection, and hematoma (presence/absence). The presence of complications is related to a worse prognosis.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Oral Health-related Quality of Life measured by OHIP-14 test
Assessment of the impact of treatment on patients' quality of life using validated instruments (OHIP-14). The higher the average value of the seven dimensions, the more negative the impact of oral health on the quality of life of an individual.Minimum of 0 points and maximum of 56 points. Lower scores: They indicate that the person experiences less impact of oral health problems on their quality of life. That is, they have fewer problems or feel less the impact of these problems in their daily lives. Intermediate scores: Suggest a moderate impact of oral health problems on quality of life. The person may experience some difficulties or discomfort related to their oral health, but they do not necessarily significantly affect their daily functioning. Higher scores: Indicate a significant impact of oral health problems on quality of life. The person may experience a wide range of problems that affect their general well-being, including pain, eating difficulties, sleep problems, etc.
Measured: 24 hours, 48 hours, 72 hours, and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study startJul 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Pérez Sayáns
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Murcia, Nueva Galimplant SLU
- Responsible party
- Sponsor-investigator, Mario Pérez Sayáns, University of Santiago de Compostela
- Investigators
- Fabio Camacho Alonso, phD, Principal investigator, Universidad de MurciaAbel García García, phD, Study chair, Universidade de Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935747
- Sponsor's protocol ID
- BTCP2025
- Acronym
- BTCP
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Analyze the Osteogenic Action of a Beta-tricalcium Phosphate-based Product in Bone Regeneration After the Extraction of Impacted Mandibular Third Molars.
- ClinicalTrials.gov ID
- NCT06935747
- Acronym / sponsor ID
- BTCP / BTCP2025
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mario Pérez SayánsUniversity, hospital or other
- Collaborators
- Universidad de Murcia, Nueva Galimplant SLU
- Study start
- Jul 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 20 Apr 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.
The general objective of this split-mouth study is to analyze the osteogenic action of BTCP during the bone regeneration process following the extraction of impacted mandibular third molars.
Detailed description
The proposed protocol is a multicenter clinical trial aimed at analyzing the osteogenic action of a medical device based on beta-tricalcium phosphate (hereinafter BTCP) in the bone regeneration process following the extraction of impacted mandibular third molars. The specific objectives of the study include a comparative analysis of clinical and radiological variables between a control group and a study group.
Inclusion criteria for study subjects include being of legal age, providing informed consent, and requiring the extraction of both impacted mandibular third molars, among others. Exclusion criteria include the presence of severe mental disorders or medical contraindications for tooth extraction.
The study involves a total of 60 third molars from 30 patients, divided into a control group and a study group. Data will be collected regarding patient demographics, the surgical procedure, and the bone regeneration assessment.
The surgical procedure involves selecting patients with similarly complex third molars, followed by tooth extraction and the placement of BTCP in the study group or a standard material in the control group. Clinical follow-up will be conducted during the first 7 days, and radiological follow-up will take place over the following 6 months to evaluate bone regeneration.
Patients will receive compensation for their participation in the study, which includes medical consultations, phone follow-ups, examination time, completion of questionnaires, and training in self-assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTCP Group | Experimental | Combination Product: Medical device: beta-tricalcium phosphateThe experimental BTCP group includes participants who will receive BTCP after the extraction of an impacted mandibular third molar to test its osteogenic properties. BTCP is prepared according to the manufacturer's instructions, initially by immersing it in sterile saline solution. It is applied to the socket after extraction using specialized instruments and is compared with a control group that receives Bio-Oss, a standard xenograft material. Patients in the experimental group receive postoperative medication, including antibiotics and pain management treatment. Follow-up evaluations assess pain, inflammation, complications, and bone regeneration through radiological assessment. Objective: To evaluate the efficacy of BTCP in bone regeneration compared to the control. |
| Control group | Active comparator | Other: Bovine HydroxyapatiteThe control group serves as the active comparator to the BTCP experimental group in this study. Participants undergo the same impacted mandibular third molar extraction procedures as those in the experimental group, but receive a standard material, Bio-Oss, instead of BTCP. Bio-Oss, a widely used xenograft material in dental surgeries, serves as the reference due to its osteoconductive properties. It is applied to the socket after extraction using specialized instruments and acts as a benchmark for comparing the efficacy of BTCP. Patients in the control group receive postoperative medication according to the study protocol, including antibiotics and pain management treatment. Follow-up assessments evaluate pain, inflammation, complications, and bone regeneration through radiological evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be of legal age, generally defined as 18 years or older, to be able to provide adequate informed consent and understand the risks and benefits of the procedure.
- Informed Consent: Patients must be willing to provide written informed consent to participate in the study, indicating their understanding and acceptance of the associated procedures and risks.
- Need for Extraction of Impacted Mandibular Third Molars: Patients must require the extraction of both impacted mandibular third molars to be eligible for the study.
- Similar Complexity of Impacted Third Molars: The impacted mandibular third molars must present similar complexity for extraction on both sides of the jaw, to ensure a fair comparison between the study groups.
- Absence of Medical Contraindications for Oral Surgical Procedures: Patients must not have significant medical contraindications that would prevent oral surgical procedures, such as clotting disorders, uncontrolled systemic diseases, or a history of severe infections.
Key exclusion criteria (5 listed)
- Severe Mental Disorders: Patients with severe mental disorders that may affect their ability to understand and follow study instructions may be excluded due to concerns about their capacity to provide valid informed consent and follow the study protocol.
- Contraindications for Dental Extractions: Patients with specific contraindications for dental extraction, such as a history of osteonecrosis of the jaws or serious complications associated with previous dental procedures, may be excluded for safety reasons.
- Patients under the age of 18 will not be eligible to participate in the study due to ethical and legal concerns related to obtaining informed consent and the ability to understand the risks and benefits of the study.
- -If a patient experiences severe complications during the study, such as severe postoperative infections, severe allergic reactions, or any other adverse event that may jeopardize their health, they will be considered for withdrawal from the study to ensure their well-being. Additionally, if a patient decides to voluntarily withdraw from the study at any time, their decision will be respected, and appropriate medical care will be provided as needed.
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 |
|---|---|---|
| Medical device: beta-tricalcium phosphateThe description of the intervention for BTCP in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. BTCP is indicated for the treatment of segmental and cavitary bone loss, aesthetic repairs, and bone augmentations (such as inlay or onlay grafts); for filling dental alveolar bone; for dental implant placement; and for the stabilization of osteotomies and prostheses in dentistry. | Combination product | BTCP Group |
| Bovine HydroxyapatiteThe intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties. | Other | Control group |
Primary outcome
Bone Regeneration_Reduction in radiolucent volume
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Reduction in radiolucent volume within the extraction socket, indicating new bone formation (Hounsfield unit (HU)). High values mean more radiopacity and better regeneration.
Bone Regeneration_bone volume
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone volume within the extraction site over time (mm3). The increase in bone volume means better regeneration
Bone Regeneration_bone density
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Changes in bone density within the regenerated bone tissue (Hounsfield unit (HU)) High values mean more radiopacity and better regeneration.
Bone Regeneration_Fractal dimension
Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone morphology within the extraction site over time analyzing the fractal dimension (FD) FD can vary between 1 and 2, with 1 being a very simple fractal dimension (such as a straight line) and 2 being a more complex fractal dimension (such as a completely irregular surface)
5 secondary outcomes
Pain levels through visual analog scale
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Clinical Inflammation evaluating by presence/absence
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Healing measured by healing index
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Post-surgical complications evaluated by presence or absense
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
Oral Health-related Quality of Life measured by OHIP-14 test
Time frame: 24 hours, 48 hours, 72 hours, and 7 days
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 24 Apr 2025.
- 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.
Fabio Camacho Alonso, phD principal investigator
Universidad de Murcia
Abel García García, phD study chair
Universidade de Santiago de Compostela
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medical device: beta-tricalcium phosphate and Bovine Hydroxyapatite in people with Bone Loss and Regenerative Inflammation, run by Mario Pérez Sayáns at 2 sites in Spain.
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 5 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 24 Apr 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 MARIO PEREZ-SAYANS GARCIA, PHD, PHD (+34626233504, mario.perez@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Regeneration_Reduction in radiolucent volume (time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months). The study lists 4 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 24 Apr 2025.