Alveolar Bone ResorptionNCT04383158
Alveolar Socket Healing With and Without PRGF
A study testing PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) in people with Alveolar Bone Resorption and Wound Heal, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
A single-centre randomised controlled pilot study involving 12-24 healthy adult patients for investigating dental extraction socket healing with and without plasma rich in growth factors (PRGF) taking place during early days of healing (days 1, 3, 7, 15, 30) and relating the healing to clinical and histological… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Wound Heal
- What is being tested?
- PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2021to 16 Apr 2024
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All of the following criteria must be fulfilled for inclusion:
- Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥25 years old.
- Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for 2/3rd of the root nor associated with acute periapical pathology.
- Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of >50% buccal bone loss, the participant will be withdrawn.
- Patient in good general health as documented by self-assessment.
- Full mouth bleeding and plaque scores (FMBS <10% and FMPS <20%) recorded within the previous 8 weeks.
Who cannot join
- Uncontrolled or untreated periodontal disease.
- History of local (head and neck) radiation therapy.
- Presence of oral lesions in the area of the extraction (such as ulceration, malignancy).
- Severe bruxing or clenching habits.
- Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible).
- Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. AIDS).
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- History of alcohol or drug abuse.
- Smokers.
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- Malocclusion, or collapse of the occlusal vertical dimension leading to dentoalveolar compensation which could interfere with ridge preservation dimensions and measurements.
- Lack of adjacent sound restored or unrestored teeth.
- Any male participants with facial hair (such as moustache, beard or any other variations of facial hair styles) and must keep their face shaven until after the placement of the dental implant (Visit 10).
- Any individuals using Botox or fillers in the face region.
- All patients to be enrolled who meet the inclusion / exclusion criteria will be asked if they have participated in any other interventional periodontal studies within the last 3 months. If the patient did participate in such studies, then enrolment will be postponed until after 3 months wash-out period has elapsed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of Wound Healing in the Dental Extraction Socket With and Without Plasma Rich in Growth Factors (PRGF). A Pilot Study
A single-centre randomised controlled pilot study involving 12-24 healthy adult patients for investigating dental extraction socket healing with and without plasma rich in growth factors (PRGF) taking place during early days of healing (days 1, 3, 7, 15, 30) and relating the healing to clinical and histological outcomes after 90 days of healing. Healing will be investigated by means of various non-invasive imaging technologies (e.g. laser scanners, thermal cameras, laser cameras) in addition to conventional technologies (e.g. bone core biopsy, 3D xray images). At 90 days of healing, dental implants will be placed in the healed sockets and implants will be restored and followed up until 12 months after connecting the prosthesis to the implant (e.g. implant crown). Dental implant outcomes (e.g. survival, success) will also be evaluated.
Read the detailed description
Randomised, controlled, single-centre, prospective, parallel-group qualitative pilot study. Objectives: the study aims to characterise wound healing events in the dental extraction socket with and without plasma rich in growth factors (PRGF) taking place during early days of healing after a dental extraction and their relation to clinical and histological outcomes after 90 days of healing. The early healing events of the post-extraction socket will be characterized in terms of volumetric changes in relation to intra-oral thermographic changes, blood flowgraphy, molecular (proteomic) changes, as well as extra-oral integrated geometric thermographic changes in tandem with clinical measures of soft tissue healing, post-operative pain assessment. The early healing events will be analysed in relation to volumetric, clinical and histomorphometric changes of new bone formation after 90 days of healing during dental implant treatment. Dental Implant outcomes will be evaluated up to 12 months after loading.
Duration: Overall, we anticipate that the study will last approximately 28 months. We estimate a 3-month study set-up period, followed by a recruitment period of 6 months. Each participant will attend 14 visits over approximately 18-19 months. The first 9 visits involve a dental extraction and follow-up until 90 days after extraction to obtain a bone core biopsy and dental implant placement. Visits 10 to 14 will be for restoring the dental implant and evaluating dental implant treatment outcomes.
- Conditions
- Alveolar Bone Resorption, Wound Heal
- Being tested
- PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)
- Keywords
- alveolar ridge preservation, autologous platelet concentrates, 3-D, randomised controlled study, plasma rich in growth factors, PRGF, Dental Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)Other
ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) is a system for obtaining plasma rich in growth factors (PRGF), which can be applied in the regeneration of bone and other connective tissues in oral surgery. PRGF is a completely autologous blood platelet concentrate that stimulates tissue regeneration due to enrichment with autologous growth factors, acting as a biological system.
| Study group | Role | What they receive |
|---|---|---|
| PRGF extraction sockets (Test) | Active comparator | Immediately after dental extraction, the socket will be filled with Plasma Rich in Growth Factors (ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)) Receives: Other: PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) |
| Unassisted extraction sockets (Control) | No intervention | Dental extraction sockets to be left to heal spontaneously unassisted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-oral geometric and thermographic changes of the alveolar ridge
Changes expressed as percentages of intra-oral geometric volumes and temperatures within a defined region of interest (ROI) at 1, 3, 7, 15, 30 and 90 days after dental extraction in unassisted socket healing and PRGF-assisted healing. The ROIs will include the buccal, crestal, and palatal surfaces of the extraction socket defined proximally between two vertical planes parallel to the tooth axis in the middle of the mesial and distal papilla, and defined superiorly by a horizontal plane at the level of the mucogingival line.dental extraction in unassisted socket healing and PRGF-assisted healing.
Measured: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Secondary outcomes (14)
Extra-oral geometric changes of the whole face at 1, 3, 7, 15, and 30 days after dental extraction
Changes expressed as percentages of extra-oral geometric volumes at selected areas of interest at 1, 3, 7, 15, and 30 days after dental extraction
Measured: From dental extraction and post-operative days 1, 3, 7, 15, and 30.
Extra-oral thermographic changes of the whole face at 1, 3, 7, 15, 30 and 90 days after dental extraction
Changes expressed as percentages of extra-oral thermographic changes at selected areas of interest at 1, 3, 7, 15, 30 and 90 days after dental extraction.
Measured: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Blood flowgraphy changes of intra-oral soft tissue of the dental extraction socket
Changes expressed as percentage of blood flowgraphy measured with Laser Speckle Contrast Imaging (LSCI) of intra-oral soft tissue of the dental extraction socket
Measured: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Molecular (proteomic) changes of wound exudate of the dental extraction socket
Descriptive account of molecular (proteomic) changes of wound exudate of the dental extraction socket after extraction based on the Normalised Spectral Abundance Factor (NSAF) proteomic analysis
Measured: From dental extraction and post-operative days 1, 3, 7, and 15.
Clinical changes of the intra-oral soft tissue of the dental extraction socket measured by soft tissue healing index of Landry (Landry, 1985)
Qualitative clinical changes of the intra-oral soft tissue of the dental extraction socket measured by soft tissue healing index of Landry (Landry, 1985)
Measured: From dental extraction and post-operative days 1, 3, 7, and 15.
Post-operative pain assessed with a visual analogue scale (VAS)
Changes in the values of reported visual analogue scale (VAS) of 10 grades (value of 1= no pain, value of 10= maximum pain) to assess post-operative pain
Measured: From dental extraction and post-operative days 1, 3, 7, and 15.
Geometric changes of 3-D radiographic bone (CBCT) and 3-D optically scanned soft tissue at suture removal (7 days) and at 90 days of healing
Percentage of geometric changes of 3-D radiographic bone (CBCT) and 3-D optically scanned soft tissue at suture removal (7 days) and at 90 days of healing
Measured: At suture removal at 7 days after dental extraction and at 90 days of healing.
Histomorphometric new bone formation assessed with histology and X-ray microtomography (XMT), to calculate the percentages of new bone within bone core samples obtained after 3 months of healing at the dental implant placement procedure
Percentage of new bone formation assessed with histological analysis and X-ray microtomography (XMT) within bone core samples obtained after 3 months of healing at the dental implant placement procedure
Measured: At 90 days of healing after dental extraction.
Feasibility of implant placement expressed as percentages (%) of implants placed with satisfactory primary stability
Percentage of implants placed with satisfactory primary stability in the optimal prosthetically driven 3-D position
Measured: At 90 days of healing after dental extraction.
Need for further augmentation expressed as a percentage (%) of implants that required further ridge augmentation procedures during implant placement for the management of residual dehiscence or fenestration defects
Percentage of implants that required further ridge augmentation procedures during implant placement for the management of residual dehiscence or fenestration defects
Measured: At 90 days of healing after dental extraction.
Implant survival and success according to success criteria of Buser et al (Buser et al., 1990) assessed at 12 months after implant loading
Percentage of implant survival and success according to success criteria of Buser et al (Buser et al 1990)
Measured: At 12 months after implant loading
- Molecular (proteomic) changes of the peri-implant crevicular fluid at suture removal after implant placement and at 6 months and 12 months after implant loading
- Descriptive account of molecular (proteomic) changes of the peri-implant crevicular fluid at suture removal after implant placement and at 6 months and 12 months after implant loading
Measured: at suture removal after implant placement and at 6 months and 12 months after implant loading.
Papilla Fill Index, Pink Esthetic Score (PES) and White Esthetic Score (WES) at 6 months and 12 months after implant loading
PFI, PES and WES scores
Measured: at 6 months and 12 months after implant loading
- Intra-oral geometric changes of the peri-implant soft tissue at 6 months and 12 months after implant loading
Percentage of geometric changes of the peri-implant soft tissues
Measured: at 6 months and 12 months after implant loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start10 Aug 2021
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies 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
- Randomised, controlled, single-centre, prospective, parallel-group qualitative pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos Donos, DDS, MS, PhD, Principal investigator, Centre for Oral Clinical Research, Institute of Dentistry, Barts & The London School of Medicine & Dentistry, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383158
- Sponsor's protocol ID
- IRAS 279109
- Status last verified
- Jul 2024
- First submitted
- 1 May 2020
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Wound Healing in the Dental Extraction Socket With and Without Plasma Rich in Growth Factors (PRGF). A Pilot Study
- ClinicalTrials.gov ID
- NCT04383158
- Acronym / sponsor ID
- IRAS 279109
- Conditions
- Alveolar Bone Resorption, Wound Heal
- Keywords
- alveolar ridge preservation, autologous platelet concentrates, 3-D, randomised controlled study, plasma rich in growth factors, PRGF, Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 12 May 2020 (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.
A single-centre randomised controlled pilot study involving 12-24 healthy adult patients for investigating dental extraction socket healing with and without plasma rich in growth factors (PRGF) taking place during early days of healing (days 1, 3, 7, 15, 30) and relating the healing to clinical and histological outcomes after 90 days of healing. Healing will be investigated by means of various non-invasive imaging technologies (e.g. laser scanners, thermal cameras, laser cameras) in addition to conventional technologies (e.g. bone core biopsy, 3D xray images). At 90 days of healing, dental implants will be placed in the healed sockets and implants will be restored and followed up until 12 months after connecting the prosthesis to the implant (e.g. implant crown). Dental implant outcomes (e.g. survival, success) will also be evaluated.
Detailed description
Randomised, controlled, single-centre, prospective, parallel-group qualitative pilot study. Objectives: the study aims to characterise wound healing events in the dental extraction socket with and without plasma rich in growth factors (PRGF) taking place during early days of healing after a dental extraction and their relation to clinical and histological outcomes after 90 days of healing. The early healing events of the post-extraction socket will be characterized in terms of volumetric changes in relation to intra-oral thermographic changes, blood flowgraphy, molecular (proteomic) changes, as well as extra-oral integrated geometric thermographic changes in tandem with clinical measures of soft tissue healing, post-operative pain assessment. The early healing events will be analysed in relation to volumetric, clinical and histomorphometric changes of new bone formation after 90 days of healing during dental implant treatment. Dental Implant outcomes will be evaluated up to 12 months after loading.
Duration: Overall, we anticipate that the study will last approximately 28 months. We estimate a 3-month study set-up period, followed by a recruitment period of 6 months. Each participant will attend 14 visits over approximately 18-19 months. The first 9 visits involve a dental extraction and follow-up until 90 days after extraction to obtain a bone core biopsy and dental implant placement. Visits 10 to 14 will be for restoring the dental implant and evaluating dental implant treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, controlled, single-centre, prospective, parallel-group qualitative pilot study
| Arm | Type | Receives |
|---|---|---|
| PRGF extraction sockets (Test) | Active comparator | Other: PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)Immediately after dental extraction, the socket will be filled with Plasma Rich in Growth Factors (ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)) |
| Unassisted extraction sockets (Control) | No intervention | –Dental extraction sockets to be left to heal spontaneously unassisted. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥25 years old.
- Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for 2/3rd of the root nor associated with acute periapical pathology.
- Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of >50% buccal bone loss, the participant will be withdrawn.
- Patient in good general health as documented by self-assessment.
- Full mouth bleeding and plaque scores (FMBS <10% and FMPS <20%) recorded within the previous 8 weeks.
Key exclusion criteria (15 listed)
- Uncontrolled or untreated periodontal disease.
- History of local (head and neck) radiation therapy.
- Presence of oral lesions in the area of the extraction (such as ulceration, malignancy).
- Severe bruxing or clenching habits.
- Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible).
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 |
|---|---|---|
| PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) is a system for obtaining plasma rich in growth factors (PRGF), which can be applied in the regeneration of bone and other connective tissues in oral surgery. PRGF is a completely autologous blood platelet concentrate that stimulates tissue regeneration due to enrichment with autologous growth factors, acting as a biological system. | Other | PRGF extraction sockets (Test) |
Primary outcome
Intra-oral geometric and thermographic changes of the alveolar ridge
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Changes expressed as percentages of intra-oral geometric volumes and temperatures within a defined region of interest (ROI) at 1, 3, 7, 15, 30 and 90 days after dental extraction in unassisted socket healing and PRGF-assisted healing. The ROIs will include the buccal, crestal, and palatal surfaces of the extraction socket defined proximally between two vertical planes parallel to the tooth axis in the middle of the mesial and distal papilla, and defined superiorly by a horizontal plane at the level of the mucogingival line.dental extraction in unassisted socket healing and PRGF-assisted healing.
14 secondary outcomes
Extra-oral geometric changes of the whole face at 1, 3, 7, 15, and 30 days after dental extraction
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, and 30.
Extra-oral thermographic changes of the whole face at 1, 3, 7, 15, 30 and 90 days after dental extraction
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Blood flowgraphy changes of intra-oral soft tissue of the dental extraction socket
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Molecular (proteomic) changes of wound exudate of the dental extraction socket
Time frame: From dental extraction and post-operative days 1, 3, 7, and 15.
Clinical changes of the intra-oral soft tissue of the dental extraction socket measured by soft tissue healing index of Landry (Landry, 1985)
Time frame: From dental extraction and post-operative days 1, 3, 7, and 15.
Post-operative pain assessed with a visual analogue scale (VAS)
Time frame: From dental extraction and post-operative days 1, 3, 7, and 15.
Geometric changes of 3-D radiographic bone (CBCT) and 3-D optically scanned soft tissue at suture removal (7 days) and at 90 days of healing
Time frame: At suture removal at 7 days after dental extraction and at 90 days of healing.
Histomorphometric new bone formation assessed with histology and X-ray microtomography (XMT), to calculate the percentages of new bone within bone core samples obtained after 3 months of healing at the dental implant placement procedure
Time frame: At 90 days of healing after dental extraction.
Feasibility of implant placement expressed as percentages (%) of implants placed with satisfactory primary stability
Time frame: At 90 days of healing after dental extraction.
Need for further augmentation expressed as a percentage (%) of implants that required further ridge augmentation procedures during implant placement for the management of residual dehiscence or fenestration defects
Time frame: At 90 days of healing after dental extraction.
Implant survival and success according to success criteria of Buser et al (Buser et al., 1990) assessed at 12 months after implant loading
Time frame: At 12 months after implant loading
- Molecular (proteomic) changes of the peri-implant crevicular fluid at suture removal after implant placement and at 6 months and 12 months after implant loading
Time frame: at suture removal after implant placement and at 6 months and 12 months after implant loading.
Papilla Fill Index, Pink Esthetic Score (PES) and White Esthetic Score (WES) at 6 months and 12 months after implant loading
Time frame: at 6 months and 12 months after implant loading
- Intra-oral geometric changes of the peri-implant soft tissue at 6 months and 12 months after implant loading
Time frame: at 6 months and 12 months after implant loading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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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.
Nikolaos Donos, DDS, MS, PhD principal investigator
Centre for Oral Clinical Research, Institute of Dentistry, Barts & The London School of Medicine & Dentistry, QMUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) in people with Alveolar Bone Resorption and Wound Heal, run by Queen Mary University of London at 1 site in United Kingdom.
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 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 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 United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-oral geometric and thermographic changes of the alveolar ridge (time frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.). 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 23 Jul 2024.