Wound HealNCT04097509
Effects of Platelet Concentrates on Palatal Wound Healing
A study testing AFG application on palatinal wound healing and i-PRF application on palatinal wound healing in people with Wound Heal and Platelets; Defect, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and… Read more about this study
- Who is it for?
- Ages 18 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Platelets; Defect, Periodontal Inflammation
- What is being tested?
- AFG application on palatinal wound healing and i-PRF application on palatinal wound healing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 10 Jun 2019
- 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 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients older than age 18
- Patients with good oral hygiene
- Patients who do not use drugs that affect wound healing
- Patients who are systemically healthy
- Patients who are non-smokers
- Patients who do not have coagulation disorder
- Patients who do not have nausea
- Patients who are not anti-inflammatory drug allergy sufferers
Who cannot join
- • Patients who have systematic disorders such as (diabetes, hypertension, radiotherapy, chemotherapy, etc.)
- Patients who use any medication that may affect wound healing
- Patients with coagulation disorders
- Patients who are smokers and alcohol users
- Patients who are pregnant and breastfeeding
- Patients with poor oral hygiene
Show all 9Show fewer
- Patients who have nausea
- Patients who are anti-inflammatory drug allergy sufferers
- Patients who do not attend regular check-ups
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University, Faculty of Dentistry, Department of Periodontics,
Malatya, 44280
About this study
Official title: Comparison of the Effects of Different Platelet Concentrates on Palatal Wound Healing
Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and postoperative comfort. In a study using a platelet rich plasma (PRP) with a different platelet concentration, PRP was found to accelerate wound healing and shorten the healing time. In another study using titanium-prepared platelet rich fibrin (T-PRF) for palatal wound healing, it accelerated the wound healing process and reached the initial level of soft tissue thickness in the donor region at the end of 6 months. In the literature, there are few studies using platelet concentrates in palatal wound healing and only some concentrates (PRP, PRF, T-PRF) are used. The aim of this study is to compare the effects of injectable platelet rich fibrin (i-PRF), which are autologous fibrin glue (AFG) and injectable platelet concentrates, on palatal wound healing. The findings obtained from this study will contribute to the literature in determining the product and method that will provide optimal postoperative patient comfort and wound healing.
Read the detailed description
Attached gingiva plays an important role in maintaining periodontal health. In the presence of inadequate attached gingiva, periodontal tissue inflammation, root sensitivity, root caries and gingival recessions are caused due to mucogingival stress in the related area and oral hygiene which is not provided adequately. In such cases, inadequate attached gingival width should be increased with mucogingival periodontal plastic surgery.
Free gingival graft (FGG) is accepted as the most commonly used mucogingival procedure in increasing the attached gingival, because of its predictable surgical outcome, simple technique and its application in large areas of operation. In the free gingival graft operation, the recipient bed is prepared in the area with insufficient attached gingiva. Free gingival grafts containing epithelial and connective tissue from the donor area are applied to this recipient bed in appropriate dimensions . Palatal region is the most preferred donor site in terms of anatomical advantage, ideal tissue thickness and wide keratinized band removal. The secondary wound in the donor site after FGG heals in 2-4 weeks and may cause problems that affect patient comfort such as paresthesia, herpetic lesion, mucocele, bleeding and pain in the postoperative period. Different products such as hemostatic agents, low-dose laser treatments, herbal products, ozonated oil, antibacterial / antiseptic agents, bioactive materials and platelet concentrates have been tested to accelerate wound healing and prevent these problems. Studies on the determination of the product and method that provide optimal postoperative patient comfort and wound healing from such products, whose effects on wound healing are known, are ongoing.
Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and postoperative comfort. In a study using a platelet rich plasma (PRP) with a different platelet concentration, PRP was found to accelerate wound healing and shorten the healing time. In another study using titanium-prepared platelet rich fibrin (T-PRF) for palatal wound healing, it accelerated the wound healing process and reached the initial level of soft tissue thickness in the donor region at the end of 6 months. In the literature, there are few studies using platelet concentrates in palatal wound healing and only some concentrates (PRP, PRF, T-PRF) are used. The aim of this study is to compare the effects of injectable platelet rich fibrin (i-PRF), which are autologous fibrin glue (AFG) and injectable platelet concentrates, on palatal wound healing. The findings obtained from this study will contribute to the literature in determining the product and method that will provide optimal postoperative patient comfort and wound healing.
In this randomized, controlled clinical study, 36 patients in need of FGG were divided into three groups. AFG (n=12) or i-PRF (n=12) was applied to donor sites and compared to control group (n=12). Wound healing with H2O2 test, VAS, MMS scale and LTH index were evaluated on the 3rd, 7th, 14th day and 1st month. The bleeding status was evaluated on 3rd and 7th days. Palatal tissue thickness was measured at baseline, 1st month and 3rd month.
AFG and i-PRF have positive effects on the healing process by accelerating wound healing and reducing postoperative morbidity.
- Being tested
- AFG application on palatinal wound healing, i-PRF application on palatinal wound healing, control
- Medical subject headings
- Blood Platelet Disorders, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFG application on palatinal wound healingBiological
9 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. In the protocol, venous blood collected in the tube was centrifuged for 2 minutes at 2700 rpm (approximately 692 g) in a special centrifuge (Medifuge, Silfradent, Italy) to obtain two layers: the lower layer of red blood cells and the upper layer of AFG. The AFG at the top of the tube was collected by means of an injector and transferred to the metal godet. It was held for 15-20 minutes for polymerization. After polymerization occurred, the polymerized AFG in the metal gum was applied to the wound surface in the donor site . No suture or tissue glue was used. Adhesive properties of AFG were utilized.
i-PRF application on palatinal wound healingBiological
10 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. Based on G force, collected venous blood were centrifuged at 2300 rpm (about 241 g) in a centrifuge (PC-O2, Process for PRF, Nice, France) for 3 minutes to obtain two layers: The two layers are the lower layer of red blood cells and the upper layer of i-PRF. The i-PRF at the top of the tube was collected with a syringe and transferred to the metal godet. It was held for 20-25 minutes for polymerization. After the polymerization, the polymerized i-PRF was applied to the wound surface in the donor site. No suture or tissue glue was used. Adhesive properties of AFG were utilized.
controlOther
no application
| Study group | Role | What they receive |
|---|---|---|
| autologous fibrin glue (AFG) group | Experimental | In the test groups, polymerized AFG was applied to the palatinal donor area. Donor palate was closed with sterile aluminum foil and periodontal pack Receives: Biological: AFG application on palatinal wound healing |
| injectable platelet rich fibrin (i-PRF) group | Experimental | In the test groups, polymerized i-PRF was applied to the donor area. Donor palate was closed with sterile aluminum foil and periodontal pack. Receives: Biological: i-PRF application on palatinal wound healing |
| Control Group | Placebo comparator | In the control group, only moist sterile tamponade was applied following graft removal to the palatinal donor area. Donor palate was closed with sterile aluminum foil and periodontal pack Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Epithelialization of wound in % at different time points
Completion of wound epithelialization was evaluated clinically using H2O2 foaming test. After the wound area was dried with gauze, 3% of hydrogen peroxide (H2O2) was applied to the wound with an injector. The result of H2O2 application was evaluated as bubbling within / without palate. The absence of foaming indicates that epithelialization is complete
Measured: Epithelialization was evaluated on the 3rd, 7th, 14th day and 1st month.
Change of color, contour and distortion of wound in the total score of scale in numerical at different time points
The Modified Manchester Scar (MMS) Scale was used to assess the color, contour, and distortion of the wound . The color of the wound was classified as a perfect match (score 0), mild mismatch (score 1), or obvious mismatch (score 2) compared to the neighboring mucosa. The contour of the wound was evaluated as similar (score 0), slightly raised or indented (score 1) and hypertrophic (score 2) when compared to surrounding tissues. Wound distortion was evaluated as no distortion (score 0), mild distortion (score 1) and obvious distortion (score 2) . The sum of the scores in the three categories shows the repair score of the wound, with a total score ranging from 0 to 6, with lower scores indicating better repair.
Measured: MMS was evaluated on the 3rd, 7th, 14th day and 1st month.
Change of redness, presence of bleeding, granulation tissue, epithelialization and suppuration in % at different time points
Wound healing was evaluated using the Landry, Turnbull, Howley (LTH) index, which classifies the healing process according to redness, presence of bleeding, granulation tissue, epithelialization and suppuration. Improvement in this index was scored between 1 (very poor recovery) and 5 (excellent recovery).The sum of the scores shows the repair score of the wound. Evaluation of wound healing process with LTH index was performed on the 3rd, 7th and 14th days and on the 1st and 3rd month controls.
Measured: LTH was evaluated on the 3rd, 7th, 14th day and 1st month.
Secondary outcomes (1)
change of Postoperative Pain Evaluation (VAS) in total score of scale in numerical at different time points
VAS was used for postoperative pain evaluation. On the two ends of a 100 mm line, the definition of 'no pain 'and 'the most severe pain of my life' was written and the patient was asked to mark the appropriate position on this line. The distance from the no pain 'end to the patient's mark was measured in millimeters to determine the patient's pain. Pain assessment was performed on the 3rd, 7th, 14th and 1st month.
Measured: VAS was evaluated on the 3rd, 7th, 14th day and 1st month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 May 2018
- Primary completion10 Feb 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a randomized, controlled clinical trial. Three groups were randomly assigned as one control and two test groups. A total of 36 patients (12 patients in each group) were included in the study. In the control group, only moist sterile tamponade was applied following graft removal to the palatinal donor area. In the test groups, polymerized AFG or polymerized i-PRF were applied to the donor area. After these procedures, donor palate was closed with sterile aluminum foil and periodontal pat in all 3 groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mustafa özay uslu, Inonu University
- Investigators
- MUSTAFA Ö USLU, Asst. Prof., Study director, Inonu University, Faculty of Dentistry, Department of Periodontics,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097509
- Sponsor's protocol ID
- 2018/46
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 20 Sep 2019
- 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 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Platelet Concentrates on Palatal Wound Healing
- ClinicalTrials.gov ID
- NCT04097509
- Acronym / sponsor ID
- 2018/46
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 10 Feb 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 20 Sep 2019 (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.
Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and postoperative comfort. In a study using a platelet rich plasma (PRP) with a different platelet concentration, PRP was found to accelerate wound healing and shorten the healing time. In another study using titanium-prepared platelet rich fibrin (T-PRF) for palatal wound healing, it accelerated the wound healing process and reached the initial level of soft tissue thickness in the donor region at the end of 6 months. In the literature, there are few studies using platelet concentrates in palatal wound healing and only some concentrates (PRP, PRF, T-PRF) are used. The aim of this study is to compare the effects of injectable platelet rich fibrin (i-PRF), which are autologous fibrin glue (AFG) and injectable platelet concentrates, on palatal wound healing. The findings obtained from this study will contribute to the literature in determining the product and method that will provide optimal postoperative patient comfort and wound healing.
Detailed description
Attached gingiva plays an important role in maintaining periodontal health. In the presence of inadequate attached gingiva, periodontal tissue inflammation, root sensitivity, root caries and gingival recessions are caused due to mucogingival stress in the related area and oral hygiene which is not provided adequately. In such cases, inadequate attached gingival width should be increased with mucogingival periodontal plastic surgery.
Free gingival graft (FGG) is accepted as the most commonly used mucogingival procedure in increasing the attached gingival, because of its predictable surgical outcome, simple technique and its application in large areas of operation. In the free gingival graft operation, the recipient bed is prepared in the area with insufficient attached gingiva. Free gingival grafts containing epithelial and connective tissue from the donor area are applied to this recipient bed in appropriate dimensions . Palatal region is the most preferred donor site in terms of anatomical advantage, ideal tissue thickness and wide keratinized band removal. The secondary wound in the donor site after FGG heals in 2-4 weeks and may cause problems that affect patient comfort such as paresthesia, herpetic lesion, mucocele, bleeding and pain in the postoperative period. Different products such as hemostatic agents, low-dose laser treatments, herbal products, ozonated oil, antibacterial / antiseptic agents, bioactive materials and platelet concentrates have been tested to accelerate wound healing and prevent these problems. Studies on the determination of the product and method that provide optimal postoperative patient comfort and wound healing from such products, whose effects on wound healing are known, are ongoing.
Platelet concentrates used in palatal wound healing have been reported to accelerate wound healing and reduce postoperative patient discomfort. The use of elet platelet rich fibrin '(PRF) in the palatal donor site after FGG surgery has been shown to provide significant benefits in terms of wound healing parameters and postoperative comfort. In a study using a platelet rich plasma (PRP) with a different platelet concentration, PRP was found to accelerate wound healing and shorten the healing time. In another study using titanium-prepared platelet rich fibrin (T-PRF) for palatal wound healing, it accelerated the wound healing process and reached the initial level of soft tissue thickness in the donor region at the end of 6 months. In the literature, there are few studies using platelet concentrates in palatal wound healing and only some concentrates (PRP, PRF, T-PRF) are used. The aim of this study is to compare the effects of injectable platelet rich fibrin (i-PRF), which are autologous fibrin glue (AFG) and injectable platelet concentrates, on palatal wound healing. The findings obtained from this study will contribute to the literature in determining the product and method that will provide optimal postoperative patient comfort and wound healing.
In this randomized, controlled clinical study, 36 patients in need of FGG were divided into three groups. AFG (n=12) or i-PRF (n=12) was applied to donor sites and compared to control group (n=12). Wound healing with H2O2 test, VAS, MMS scale and LTH index were evaluated on the 3rd, 7th, 14th day and 1st month. The bleeding status was evaluated on 3rd and 7th days. Palatal tissue thickness was measured at baseline, 1st month and 3rd month.
AFG and i-PRF have positive effects on the healing process by accelerating wound healing and reducing postoperative morbidity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study was designed as a randomized, controlled clinical trial. Three groups were randomly assigned as one control and two test groups. A total of 36 patients (12 patients in each group) were included in the study. In the control group, only moist sterile tamponade was applied following graft removal to the palatinal donor area. In the test groups, polymerized AFG or polymerized i-PRF were applied to the donor area. After these procedures, donor palate was closed with sterile aluminum foil and periodontal pat in all 3 groups.
| Arm | Type | Receives |
|---|---|---|
| autologous fibrin glue (AFG) group | Experimental | Biological: AFG application on palatinal wound healingIn the test groups, polymerized AFG was applied to the palatinal donor area. Donor palate was closed with sterile aluminum foil and periodontal pack |
| injectable platelet rich fibrin (i-PRF) group | Experimental | Biological: i-PRF application on palatinal wound healingIn the test groups, polymerized i-PRF was applied to the donor area. Donor palate was closed with sterile aluminum foil and periodontal pack. |
| Control Group | Placebo comparator | Other: controlIn the control group, only moist sterile tamponade was applied following graft removal to the palatinal donor area. Donor palate was closed with sterile aluminum foil and periodontal pack |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Patients older than age 18
Key exclusion criteria (9 listed)
- • Patients who have systematic disorders such as (diabetes, hypertension, radiotherapy, chemotherapy, etc.)
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 |
|---|---|---|
| AFG application on palatinal wound healing9 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. In the protocol, venous blood collected in the tube was centrifuged for 2 minutes at 2700 rpm (approximately 692 g) in a special centrifuge (Medifuge, Silfradent, Italy) to obtain two layers: the lower layer of red blood cells and the upper layer of AFG. The AFG at the top of the tube was collected by means of an injector and transferred to the metal godet. It was held for 15-20 minutes for polymerization. After polymerization occurred, the polymerized AFG in the metal gum was applied to the wound surface in the donor site . No suture or tissue glue was used. Adhesive properties of AFG were utilized. | Biological | autologous fibrin glue (AFG) group |
| i-PRF application on palatinal wound healing10 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. Based on G force, collected venous blood were centrifuged at 2300 rpm (about 241 g) in a centrifuge (PC-O2, Process for PRF, Nice, France) for 3 minutes to obtain two layers: The two layers are the lower layer of red blood cells and the upper layer of i-PRF. The i-PRF at the top of the tube was collected with a syringe and transferred to the metal godet. It was held for 20-25 minutes for polymerization. After the polymerization, the polymerized i-PRF was applied to the wound surface in the donor site. No suture or tissue glue was used. Adhesive properties of AFG were utilized. | Biological | injectable platelet rich fibrin (i-PRF) group |
| controlno application | Other | Control Group |
Primary outcome
Change of Epithelialization of wound in % at different time points
Time frame: Epithelialization was evaluated on the 3rd, 7th, 14th day and 1st month.
Completion of wound epithelialization was evaluated clinically using H2O2 foaming test. After the wound area was dried with gauze, 3% of hydrogen peroxide (H2O2) was applied to the wound with an injector. The result of H2O2 application was evaluated as bubbling within / without palate. The absence of foaming indicates that epithelialization is complete
Change of color, contour and distortion of wound in the total score of scale in numerical at different time points
Time frame: MMS was evaluated on the 3rd, 7th, 14th day and 1st month.
The Modified Manchester Scar (MMS) Scale was used to assess the color, contour, and distortion of the wound . The color of the wound was classified as a perfect match (score 0), mild mismatch (score 1), or obvious mismatch (score 2) compared to the neighboring mucosa. The contour of the wound was evaluated as similar (score 0), slightly raised or indented (score 1) and hypertrophic (score 2) when compared to surrounding tissues. Wound distortion was evaluated as no distortion (score 0), mild distortion (score 1) and obvious distortion (score 2) . The sum of the scores in the three categories shows the repair score of the wound, with a total score ranging from 0 to 6, with lower scores indicating better repair.
Change of redness, presence of bleeding, granulation tissue, epithelialization and suppuration in % at different time points
Time frame: LTH was evaluated on the 3rd, 7th, 14th day and 1st month.
Wound healing was evaluated using the Landry, Turnbull, Howley (LTH) index, which classifies the healing process according to redness, presence of bleeding, granulation tissue, epithelialization and suppuration. Improvement in this index was scored between 1 (very poor recovery) and 5 (excellent recovery).The sum of the scores shows the repair score of the wound. Evaluation of wound healing process with LTH index was performed on the 3rd, 7th and 14th days and on the 1st and 3rd month controls.
1 secondary outcome
change of Postoperative Pain Evaluation (VAS) in total score of scale in numerical at different time points
Time frame: VAS was evaluated on the 3rd, 7th, 14th day and 1st month.
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 20 Sep 2019.
- 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.
MUSTAFA Ö USLU, Asst. Prof. study director
Inonu University, Faculty of Dentistry, Department of Periodontics,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFG application on palatinal wound healing and i-PRF application on palatinal wound healing in people with Wound Heal and Platelets; Defect, run by Inonu University at 1 site in Turkey (Türkiye).
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 8 inclusion and 9 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 20 Sep 2019. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Change of Epithelialization of wound in % at different time points (time frame: Epithelialization was evaluated on the 3rd, 7th, 14th day and 1st month.). The study lists 3 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 20 Sep 2019.