Tooth ExtractionNCT03985033
The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing
A study testing leucocyte and platelet-rich fibrin (L-PRF) in people with Tooth Extraction, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Hong Kong.
Trial summary
This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on post-extraction sockets healing. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- leucocyte and platelet-rich fibrin (L-PRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2019to 31 Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Healthy males and females of age 18-70
- Need for two or more extractions of single rooted teeth in the presence of adjacent teeth or implants due to unrestorable caries, residual roots, root fractures or orthodontic treatment
- Able (in the investigators opinion) and willing to comply with all study requirements
- Interested in tooth replacement with dental implants
Who cannot join
- Endodontic periapical lesions with a diameter of more than 5 mm (radiographically determined)
- Sites with buccal and lingual bone plate loss more than 5 mm
- Frank purulence or acute abscess at the time of extraction
- Pregnancy or lactation
- Smokers or alcoholics
- Platelet dysfunction syndrome or thrombocytopenia
- Uncontrolled diabetes
- Medical contraindications to elective oral surgery procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial
This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on post-extraction sockets healing.
Read the detailed description
Tooth extraction is one of the most frequent dental surgical procedures. Following tooth extraction, dimensional changes of the alveolus are inevitable, which consequently decrease the height and width of alveolar bone and impair ideal implant placement and conventional prosthetic treatment. In order to reduce the bone resorption after tooth extraction, the use of platelet concentrates has been proposed. Platelet rich fibrin (PRF) is a second generation of platelet concentrates consisting of platelets, leukocyte and growth factors harvested from blood. PRF not only supports hemostasis but also favors the natural wound healing process. Over the past decade, PRF has gained tremendous momentum having been utilized for a variety of dental and medical procedures including the management of post-extraction sockets. To date, several studies have assessed the efficacy of the use of PRF in promoting postextraction sockets healing. However, results remain contradictory and mainly focus on the clinical and radiological hard and soft tissue healing, aesthetics and postoperative discomfort. The mechanistic hypothesis is that growth factors released by PRF preparations modulate the wound healing process but the effect of local PRF application on the kinetics of release of wound healing modulators has not been studied so far. There is also a lack of information in the literature regarding the biological evaluation during postextraction sockets healing to understand the potential mechanisms. In order to assess the presence or follow dynamics of biomarkers, in this study wound fluid (WF) will be collected from the post-extraction sockets and utilized for multiplex immunoassay. Multiplex immunoassay allows simultaneous quantification of multiple markers providing unique information for a more complete understanding of the potential mechanism of PRF and spontaneous extraction socket healing. Therefore, the aim of this randomized clinical trial is to evaluate the effects of PRF on biomarkers response during post-extraction sockets healing.
- Conditions
- Tooth Extraction
- Being tested
- leucocyte and platelet-rich fibrin (L-PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leucocyte and platelet-rich fibrin (L-PRF)Other
The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF.
| Study group | Role | What they receive |
|---|---|---|
| L-PRF | Experimental | Post-extraction sockets will be filled with autologous leucocyte and platelet-rich fibrin (L-PRF) clot. Receives: Other: leucocyte and platelet-rich fibrin (L-PRF) |
| Control | No intervention | Post-extraction sockets will be left to heal spontaneously with natural blood clot. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations changes of the molecules and inflammatory mediators
Concentrations changes of the molecules and inflammatory mediators in the gingival crevicular fluid (GCF) or wound fluid (WF) from the extraction sockets in L-PRF group and control group at baseline (from GCF), 6 hours, 24 hours, 3 days, 7 days.
Measured: Baseline, 6 hours, 24 hours, 3 days and 7 days
Secondary outcomes (5)
Genes expression profiles
Genes expression profiles of the growth and differentiation factors and inflammatory mediators from the tissue specimen taken from the post-extraction sockets at 3 days.
Measured: Baseline and 3 days
Laser Doppler Flowmetry (LDF) measurement
A commercially available Laser Doppler Blood FlowMeter equipped with a standard fiber optic probe will be used for LDF measurements before tooth extraction, immediately postoperatively, 6 hours, 24 hours, 3 days and 7 days.
Measured: Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days
Radiographic bone changes (Cone-beam computed tomography)
Cone-beam computed tomography (CBCT) images will be obtained before extraction as the baseline and at the 4 months.
Measured: Baseline and 4 months
Wound Healing Index (HI)
Soft tissue healing will be assessed by Wound Healing Index (1 = very poor, 2 = poor, 3 = good, 4 = very good, 5 = excellent).
Measured: 6 hours, 24 hours, 3 days and 7 days
Visual analog scale (VAS)
A 10-point VAS with a score of 0 that equals "no pain" and a score of 10 that equals "worst pain imaginable" will be used to evaluate the postoperative pain at 6 hours, 24 hours, 3 days and 7 days. The patients will be asked to fill the pain they feel at the time of questioning. Questionnaires will be collected at the one-week follow-up visit.
Measured: 6 hours, 24 hours, 3 days 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 posted13 Jun 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design allowing to assess two types of treatment in the same patient.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)
- Sponsor type
- Research network
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Maurizio Tonetti, The University of Hong Kong
- Investigators
- Maurizio Tonetti, DMD, Principal investigator, The European Research Group on Periodontology (ERGOPerio)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985033
- Sponsor's protocol ID
- HKUPhD20190528
- Status last verified
- Jan 2022
- First submitted
- 10 Jun 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alssum L, Eubank TD, Roy S, Erdal BS, Yildiz VO, Tatakis DN, Leblebicioglu B. Gingival Perfusion and Tissue Biomarkers During Early Healing of Postextraction Regenerative Procedures: A Prospective Case Series. J Periodontol. 2017 Nov;88(11):1163-1172. doi: 10.1902/jop.2017.170117. Epub 2017 Jun 23.
PubMed 28644107Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082.
PubMed 25867983Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
PubMed 30623987Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.
PubMed 24966231Buser D, Hoffmann B, Bernard JP, Lussi A, Mettler D, Schenk RK. Evaluation of filling materials in membrane--protected bone defects. A comparative histomorphometric study in the mandible of miniature pigs. Clin Oral Implants Res. 1998 Jun;9(3):137-50. doi: 10.1034/j.1600-0501.1998.090301.x.
PubMed 10530128Chan D, Pelekos G, Ho D, Cortellini P, Tonetti MS. The depth of the implant mucosal tunnel modifies the development and resolution of experimental peri-implant mucositis: A case-control study. J Clin Periodontol. 2019 Feb;46(2):248-255. doi: 10.1111/jcpe.13066. Epub 2019 Feb 7.
PubMed 30638273Del Fabbro M, Bucchi C, Lolato A, Corbella S, Testori T, Taschieri S. Healing of Postextraction Sockets Preserved With Autologous Platelet Concentrates. A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2017 Aug;75(8):1601-1615. doi: 10.1016/j.joms.2017.02.009. Epub 2017 Feb 20.
PubMed 28288724Franceschi RT. Biological approaches to bone regeneration by gene therapy. J Dent Res. 2005 Dec;84(12):1093-103. doi: 10.1177/154405910508401204.
PubMed 16304438Gamal AY, Abdel Ghaffar KA, Alghezwy OA. Crevicular Fluid Growth Factors Release Profile Following the Use of Platelet-Rich Fibrin and Plasma Rich Growth Factors in Treating Periodontal Intrabony Defects: A Randomized Clinical Trial. J Periodontol. 2016 Jun;87(6):654-62. doi: 10.1902/jop.2016.150314. Epub 2016 Feb 15.
PubMed 26876351Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.
PubMed 22211307Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
PubMed 23163915Kampfer H, Pfeilschifter J, Frank S. Expressional regulation of angiopoietin-1 and -2 and the tie-1 and -2 receptor tyrosine kinases during cutaneous wound healing: a comparative study of normal and impaired repair. Lab Invest. 2001 Mar;81(3):361-73. doi: 10.1038/labinvest.3780244.
PubMed 11310829Lin Z, Rios HF, Volk SL, Sugai JV, Jin Q, Giannobile WV. Gene expression dynamics during bone healing and osseointegration. J Periodontol. 2011 Jul;82(7):1007-17. doi: 10.1902/jop.2010.100577. Epub 2010 Dec 13.
PubMed 21142982Marenzi G, Riccitiello F, Tia M, di Lauro A, Sammartino G. Influence of Leukocyte- and Platelet-Rich Fibrin (L-PRF) in the Healing of Simple Postextraction Sockets: A Split-Mouth Study. Biomed Res Int. 2015;2015:369273. doi: 10.1155/2015/369273. Epub 2015 Jul 26.
PubMed 26273612Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, Chandad F, Nacopoulos C, Simonpieri A, Aalam AA, Felice P, Sammartino G, Ghanaati S, Hernandez MA, Choukroun J. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017 Jul;21(6):1913-1927. doi: 10.1007/s00784-017-2133-z. Epub 2017 May 27.
PubMed 28551729
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03985033
- Acronym / sponsor ID
- HKUPhD20190528
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)Research network
- Collaborators
- The University of Hong Kong
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Jun 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.
This study evaluates the clinical and biological effects of leucocyte and platelet-rich fibrin (L-PRF) on post-extraction sockets healing.
Detailed description
Tooth extraction is one of the most frequent dental surgical procedures. Following tooth extraction, dimensional changes of the alveolus are inevitable, which consequently decrease the height and width of alveolar bone and impair ideal implant placement and conventional prosthetic treatment. In order to reduce the bone resorption after tooth extraction, the use of platelet concentrates has been proposed. Platelet rich fibrin (PRF) is a second generation of platelet concentrates consisting of platelets, leukocyte and growth factors harvested from blood. PRF not only supports hemostasis but also favors the natural wound healing process. Over the past decade, PRF has gained tremendous momentum having been utilized for a variety of dental and medical procedures including the management of post-extraction sockets. To date, several studies have assessed the efficacy of the use of PRF in promoting postextraction sockets healing. However, results remain contradictory and mainly focus on the clinical and radiological hard and soft tissue healing, aesthetics and postoperative discomfort. The mechanistic hypothesis is that growth factors released by PRF preparations modulate the wound healing process but the effect of local PRF application on the kinetics of release of wound healing modulators has not been studied so far. There is also a lack of information in the literature regarding the biological evaluation during postextraction sockets healing to understand the potential mechanisms. In order to assess the presence or follow dynamics of biomarkers, in this study wound fluid (WF) will be collected from the post-extraction sockets and utilized for multiplex immunoassay. Multiplex immunoassay allows simultaneous quantification of multiple markers providing unique information for a more complete understanding of the potential mechanism of PRF and spontaneous extraction socket healing. Therefore, the aim of this randomized clinical trial is to evaluate the effects of PRF on biomarkers response during post-extraction sockets healing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design allowing to assess two types of treatment in the same patient.
| Arm | Type | Receives |
|---|---|---|
| L-PRF | Experimental | Other: leucocyte and platelet-rich fibrin (L-PRF)Post-extraction sockets will be filled with autologous leucocyte and platelet-rich fibrin (L-PRF) clot. |
| Control | No intervention | –Post-extraction sockets will be left to heal spontaneously with natural blood clot. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study
- Healthy males and females of age 18-70
- Need for two or more extractions of single rooted teeth in the presence of adjacent teeth or implants due to unrestorable caries, residual roots, root fractures or orthodontic treatment
- Able (in the investigators opinion) and willing to comply with all study requirements
- Interested in tooth replacement with dental implants
Key exclusion criteria (8 listed)
- Endodontic periapical lesions with a diameter of more than 5 mm (radiographically determined)
- Sites with buccal and lingual bone plate loss more than 5 mm
- Frank purulence or acute abscess at the time of extraction
- Pregnancy or lactation
- Smokers or alcoholics
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 |
|---|---|---|
| leucocyte and platelet-rich fibrin (L-PRF)The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF. | Other | L-PRF |
Primary outcome
Concentrations changes of the molecules and inflammatory mediators
Time frame: Baseline, 6 hours, 24 hours, 3 days and 7 days
Concentrations changes of the molecules and inflammatory mediators in the gingival crevicular fluid (GCF) or wound fluid (WF) from the extraction sockets in L-PRF group and control group at baseline (from GCF), 6 hours, 24 hours, 3 days, 7 days.
5 secondary outcomes
Genes expression profiles
Time frame: Baseline and 3 days
Laser Doppler Flowmetry (LDF) measurement
Time frame: Before and immediately after the tooth extraction, 6 hours, 24 hours, 3 days and 7 days
Radiographic bone changes (Cone-beam computed tomography)
Time frame: Baseline and 4 months
Wound Healing Index (HI)
Time frame: 6 hours, 24 hours, 3 days and 7 days
Visual analog scale (VAS)
Time frame: 6 hours, 24 hours, 3 days and 7 days
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 11 Jan 2022.
- Background: PubMed 28644107Alssum L, Eubank TD, Roy S, Erdal BS, Yildiz VO, Tatakis DN, Leblebicioglu B. Gingival Perfusion and Tissue Biomarkers During Early Healing of Postextraction Regenerative Procedures: A Prospective Case Series. J Periodontol. 2017 Nov;88(11):1163-1172. doi: 10.1902/jop.2017.170117. Epub 2017 Jun 23.
- Background: PubMed 25867983Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082.
- Background: PubMed 30623987Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
- Background: PubMed 24966231Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.
- Background: PubMed 10530128Buser D, Hoffmann B, Bernard JP, Lussi A, Mettler D, Schenk RK. Evaluation of filling materials in membrane--protected bone defects. A comparative histomorphometric study in the mandible of miniature pigs. Clin Oral Implants Res. 1998 Jun;9(3):137-50. doi: 10.1034/j.1600-0501.1998.090301.x.
- Background: PubMed 30638273Chan D, Pelekos G, Ho D, Cortellini P, Tonetti MS. The depth of the implant mucosal tunnel modifies the development and resolution of experimental peri-implant mucositis: A case-control study. J Clin Periodontol. 2019 Feb;46(2):248-255. doi: 10.1111/jcpe.13066. Epub 2019 Feb 7.
- Background: PubMed 28288724Del Fabbro M, Bucchi C, Lolato A, Corbella S, Testori T, Taschieri S. Healing of Postextraction Sockets Preserved With Autologous Platelet Concentrates. A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2017 Aug;75(8):1601-1615. doi: 10.1016/j.joms.2017.02.009. Epub 2017 Feb 20.
- Background: PubMed 16304438Franceschi RT. Biological approaches to bone regeneration by gene therapy. J Dent Res. 2005 Dec;84(12):1093-103. doi: 10.1177/154405910508401204.
- Background: PubMed 26876351Gamal AY, Abdel Ghaffar KA, Alghezwy OA. Crevicular Fluid Growth Factors Release Profile Following the Use of Platelet-Rich Fibrin and Plasma Rich Growth Factors in Treating Periodontal Intrabony Defects: A Randomized Clinical Trial. J Periodontol. 2016 Jun;87(6):654-62. doi: 10.1902/jop.2016.150314. Epub 2016 Feb 15.
- Background: PubMed 22211307Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.
- Background: PubMed 23163915Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
- Background: PubMed 11310829Kampfer H, Pfeilschifter J, Frank S. Expressional regulation of angiopoietin-1 and -2 and the tie-1 and -2 receptor tyrosine kinases during cutaneous wound healing: a comparative study of normal and impaired repair. Lab Invest. 2001 Mar;81(3):361-73. doi: 10.1038/labinvest.3780244.
- 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.
Maurizio Tonetti, DMD principal investigator
The European Research Group on Periodontology (ERGOPerio)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leucocyte and platelet-rich fibrin (L-PRF) in people with Tooth Extraction, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Concentrations changes of the molecules and inflammatory mediators (time frame: Baseline, 6 hours, 24 hours, 3 days and 7 days). 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 NCT03985033, which also lists 24 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 11 Jan 2022.