Composite ResinsNCT04600297
3 Years Clinical Evaluation of 3D Printed Resin Composite Fixed Dental Prosthesis
A study testing ELS Even Stronger (3D Printed Resin Composite) in people with Composite Resins and Dental Prosthesis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
In recent years there is a rapid increase in the use of computer aided design and production. Two main types of materials are used in the production of indirect CAD/CAM restorations namely resin composite based and ceramic ones. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Composite Resins, Dental Prosthesis
- What is being tested?
- ELS Even Stronger (3D Printed Resin Composite)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2020to 1 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Need for a three-unit posterior FDP
- One missing tooth from the second premolar to the second molar where 1st molar is missing (pontic replacing 1st molar)
- Presence of opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth)
- Only FPD s with end abutments (No cantilever)
- Sufficient length of the clinical crown (>5 mm)
- No obvious untreated caries, dental health problems (regularly checked by a dentist)
Show all 11Show fewer
- Good or moderate oral hygiene (plaque score of less than 30% in anterior region be-fore treatment)
- No untreated periodontal disease (only DPSI 1, 2)
- Abutment teeth are vital or endodontically treated with a sealed root filling to the apical region, and have to be without apical periodontitis for the past 6 months.
- Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
- Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.
Who cannot join
- Patients suffering from general health impairment
- Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or - Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Endodontic treatment with extensive loss of tooth tissue
- Subjects who presented with severe wear facets and/or reported parafunctional activi-ties such as clenching or nocturnal bruxism
- Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
- Subjects who were pregnant during the duration of the study
- Subjects who are known to be allergic to the ingredients of resin materials
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Medipol University, School of Dentistry
Istanbul, 34083
Muzaffer Ateş, Prof.Dr., +905326134765, mates@medipol.edu.tr
Tuğba Toz, Assos. Prof., +905433242554, tuuuuba2008@hotmail.com
About this study
Official title: Clinical Evaluation of 3D Printed Resin Composite Posterior Fixed Dental Prosthesis: A Prospective Clinical Trial up to 3 Years
In recent years there is a rapid increase in the use of computer aided design and production. Two main types of materials are used in the production of indirect CAD/CAM restorations namely resin composite based and ceramic ones. Mechanical properties and esthetics of ceramic materials are superior to resin composites but the advantages of intraoral repair, easy adjustments and polish of resin materials are undeniable. Improvements of mechanical properties of resin-based materials resulted in the development of resin composite blocks.
3D printed restorations, which can be performed as chairside in one session can be manufactured in case of any broken / chipping / debonding cases, without the need for repeated impression making. This saves time for the patient and the clinician. By using these 3D resin-based composite materials in fixed partial dentures, intraoral repairs can be performed. In addition, the high costs of burs and possible damage to the CAD/CAM blocks used in ceramic milling are eliminated when restoration are manufactured in printers with the DLP technology.
The objective of this study was to evaluate the clinical outcome of 3D printed posterior resin composite FDP restorations up to 3 years.
Read the detailed description
The study will be carried out as a prospective study, with assessment of the restorations after three year. The project includes 3-unit posterior fixed dental prosthesis (FDP) for 70 cases.
Patients participating in the investigation are going to be informed by the "Clinicians" on the background and risk of the investigation. Patients have to give their written consent to participate in the investigation.
The treatment procedure includes the following steps:
Preparation scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing and cementation of the FDP.
The control procedures:
Two weeks after cementation, baseline control will be performed according to USPHS and FDI 2. The restorations will be evaluated at 3 years recall.
- Conditions
- Composite Resins, Dental Prosthesis
- Being tested
- ELS Even Stronger (3D Printed Resin Composite)
- Keywords
- 3D printed fixed prosthesis, resin composite dental prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELS Even Stronger (3D Printed Resin Composite)Device
Missing of one premolar cases will be restored using the 3D Printed resin composite (ELS Even Stronger, Saremco, Switzerland). The steps of the procedure: Preparation, scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing, cementation.
| Study group | Role | What they receive |
|---|---|---|
| 3D printed resin composite posterior FDP | Experimental | Three units posterior fixed dental prosthesis made with 3D printed resin composite material Receives: Device: ELS Even Stronger (3D Printed Resin Composite) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified FDI (World Dental Federation) criteria for dental restoration assessment
The FDI (World Dental Federation) criteria for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. The criteria were categorized into three groups: esthetic, functional and biological parameters. Each criterion can be expressed with five scores, three for acceptable and two for non-acceptable (one for reparable and one for replacement). The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome. Two independent evaluators will evaluate the restorations by using modified FDI criteria.
Measured: 3 years
Secondary outcomes (2)
Plaque accumulation according to the Silness & Löe (1964) Plaque Index
0 = No plaque in the gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, on the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent
Measured: 3 years
Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
0 = Normal gingival.
- = Mild inflammation-slight change in colour, slight oedema. No bleeding on probing
- = Moderate inflammation-redness, oedema and glazing. Bleeding on probing.
- = Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start10 Oct 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Composite ResinsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Cases of one missing posterior tooth to be restored with 3D printed resin composite posterior FDP
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saremco Dental AG
- Responsible party
- Principal investigator, Mehmet Muzaffer Ateş, Istanbul Medipol University Hospital
- Investigators
- Mutlu Özcan, Prof.Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600297
- Sponsor's protocol ID
- 68869993-511.06-.E.150622
- Status last verified
- Aug 2021
- First submitted
- 13 Oct 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rekow ED. Dental CAD/CAM systems: a 20-year success story. J Am Dent Assoc. 2006 Sep;137 Suppl:5S-6S. doi: 10.14219/jada.archive.2006.0396. No abstract available.
PubMed 16950931Miyazaki T, Hotta Y, Kunii J, Kuriyama S, Tamaki Y. A review of dental CAD/CAM: current status and future perspectives from 20 years of experience. Dent Mater J. 2009 Jan;28(1):44-56. doi: 10.4012/dmj.28.44.
PubMed 19280967Ruse ND, Sadoun MJ. Resin-composite blocks for dental CAD/CAM applications. J Dent Res. 2014 Dec;93(12):1232-4. doi: 10.1177/0022034514553976. Epub 2014 Oct 24.
PubMed 25344335Zimmermann M, Ender A, Egli G, Ozcan M, Mehl A. Fracture load of CAD/CAM-fabricated and 3D-printed composite crowns as a function of material thickness. Clin Oral Investig. 2019 Jun;23(6):2777-2784. doi: 10.1007/s00784-018-2717-2. Epub 2018 Oct 27.
PubMed 30368664Alharbi A, Ardu S, Bortolotto T, Krejci I. Stain susceptibility of composite and ceramic CAD/CAM blocks versus direct resin composites with different resinous matrices. Odontology. 2017 Apr;105(2):162-169. doi: 10.1007/s10266-016-0258-1. Epub 2016 Jul 25.
PubMed 27456684Kamonwanon P, Hirose N, Yamaguchi S, Sasaki JI, Kitagawa H, Kitagawa R, Thaweboon S, Srikhirin T, Imazato S. SiO2-nanocomposite film coating of CAD/CAM composite resin blocks improves surface hardness and reduces susceptibility to bacterial adhesion. Dent Mater J. 2017 Jan 31;36(1):88-94. doi: 10.4012/dmj.2016-135. Epub 2016 Dec 6.
PubMed 27928105Mitra SB, Wu D, Holmes BN. An application of nanotechnology in advanced dental materials. J Am Dent Assoc. 2003 Oct;134(10):1382-90. doi: 10.14219/jada.archive.2003.0054.
PubMed 14620019Deliperi S, Bardwell DN. Clinical evaluation of direct cuspal coverage with posterior composite resin restorations. J Esthet Restor Dent. 2006;18(5):256-65; discussion 266-7. doi: 10.1111/j.1708-8240.2006.00033.x.
PubMed 16987320Yesil ZD, Alapati S, Johnston W, Seghi RR. Evaluation of the wear resistance of new nanocomposite resin restorative materials. J Prosthet Dent. 2008 Jun;99(6):435-43. doi: 10.1016/S0022-3913(08)60105-5.
PubMed 18514665Zimmermann M, Koller C, Reymus M, Mehl A, Hickel R. Clinical Evaluation of Indirect Particle-Filled Composite Resin CAD/CAM Partial Crowns after 24 Months. J Prosthodont. 2018 Oct;27(8):694-699. doi: 10.1111/jopr.12582. Epub 2017 Apr 19.
PubMed 28422359Shembish FA, Tong H, Kaizer M, Janal MN, Thompson VP, Opdam NJ, Zhang Y. Fatigue resistance of CAD/CAM resin composite molar crowns. Dent Mater. 2016 Apr;32(4):499-509. doi: 10.1016/j.dental.2015.12.005. Epub 2016 Jan 8.
PubMed 26777092Schlichting LH, Maia HP, Baratieri LN, Magne P. Novel-design ultra-thin CAD/CAM composite resin and ceramic occlusal veneers for the treatment of severe dental erosion. J Prosthet Dent. 2011 Apr;105(4):217-26. doi: 10.1016/S0022-3913(11)60035-8.
PubMed 21458646Magne P, Schlichting LH, Maia HP, Baratieri LN. In vitro fatigue resistance of CAD/CAM composite resin and ceramic posterior occlusal veneers. J Prosthet Dent. 2010 Sep;104(3):149-57. doi: 10.1016/S0022-3913(10)60111-4.
PubMed 20813228Magne P, Stanley K, Schlichting LH. Modeling of ultrathin occlusal veneers. Dent Mater. 2012 Jul;28(7):777-82. doi: 10.1016/j.dental.2012.04.002. Epub 2012 May 9.
PubMed 22575740El-Damanhoury HM, Haj-Ali RN, Platt JA. Fracture resistance and microleakage of endocrowns utilizing three CAD-CAM blocks. Oper Dent. 2015 Mar-Apr;40(2):201-10. doi: 10.2341/13-143-L. Epub 2014 Sep 30.
PubMed 25268039
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3D Printed Resin Composite Posterior Fixed Dental Prosthesis: A Prospective Clinical Trial up to 3 Years
- ClinicalTrials.gov ID
- NCT04600297
- Acronym / sponsor ID
- 68869993-511.06-.E.150622
- Conditions
- Composite Resins, Dental Prosthesis
- Keywords
- 3D printed fixed prosthesis, resin composite dental prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Saremco Dental AG
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 23 Oct 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.
In recent years there is a rapid increase in the use of computer aided design and production. Two main types of materials are used in the production of indirect CAD/CAM restorations namely resin composite based and ceramic ones. Mechanical properties and esthetics of ceramic materials are superior to resin composites but the advantages of intraoral repair, easy adjustments and polish of resin materials are undeniable. Improvements of mechanical properties of resin-based materials resulted in the development of resin composite blocks.
3D printed restorations, which can be performed as chairside in one session can be manufactured in case of any broken / chipping / debonding cases, without the need for repeated impression making. This saves time for the patient and the clinician. By using these 3D resin-based composite materials in fixed partial dentures, intraoral repairs can be performed. In addition, the high costs of burs and possible damage to the CAD/CAM blocks used in ceramic milling are eliminated when restoration are manufactured in printers with the DLP technology.
The objective of this study was to evaluate the clinical outcome of 3D printed posterior resin composite FDP restorations up to 3 years.
Detailed description
The study will be carried out as a prospective study, with assessment of the restorations after three year. The project includes 3-unit posterior fixed dental prosthesis (FDP) for 70 cases.
Patients participating in the investigation are going to be informed by the "Clinicians" on the background and risk of the investigation. Patients have to give their written consent to participate in the investigation.
The treatment procedure includes the following steps:
Preparation scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing and cementation of the FDP.
The control procedures:
Two weeks after cementation, baseline control will be performed according to USPHS and FDI 2. The restorations will be evaluated at 3 years recall.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cases of one missing posterior tooth to be restored with 3D printed resin composite posterior FDP
| Arm | Type | Receives |
|---|---|---|
| 3D printed resin composite posterior FDP | Experimental | Device: ELS Even Stronger (3D Printed Resin Composite)Three units posterior fixed dental prosthesis made with 3D printed resin composite material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Need for a three-unit posterior FDP
- One missing tooth from the second premolar to the second molar where 1st molar is missing (pontic replacing 1st molar)
- Presence of opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth)
- Only FPD s with end abutments (No cantilever)
- Sufficient length of the clinical crown (>5 mm)
Key exclusion criteria (7 listed)
- Patients suffering from general health impairment
- Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or - Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Endodontic treatment with extensive loss of tooth tissue
- Subjects who presented with severe wear facets and/or reported parafunctional activi-ties such as clenching or nocturnal bruxism
- Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
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 |
|---|---|---|
| ELS Even Stronger (3D Printed Resin Composite)Missing of one premolar cases will be restored using the 3D Printed resin composite (ELS Even Stronger, Saremco, Switzerland). The steps of the procedure: Preparation, scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing, cementation. | Device | 3D printed resin composite posterior FDP |
Primary outcome
Modified FDI (World Dental Federation) criteria for dental restoration assessment
Time frame: 3 years
The FDI (World Dental Federation) criteria for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. The criteria were categorized into three groups: esthetic, functional and biological parameters. Each criterion can be expressed with five scores, three for acceptable and two for non-acceptable (one for reparable and one for replacement). The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome. Two independent evaluators will evaluate the restorations by using modified FDI criteria.
2 secondary outcomes
Plaque accumulation according to the Silness & Löe (1964) Plaque Index
Time frame: 3 years
Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Background: PubMed 16950931Rekow ED. Dental CAD/CAM systems: a 20-year success story. J Am Dent Assoc. 2006 Sep;137 Suppl:5S-6S. doi: 10.14219/jada.archive.2006.0396. No abstract available.
- Background: PubMed 19280967Miyazaki T, Hotta Y, Kunii J, Kuriyama S, Tamaki Y. A review of dental CAD/CAM: current status and future perspectives from 20 years of experience. Dent Mater J. 2009 Jan;28(1):44-56. doi: 10.4012/dmj.28.44.
- Background: PubMed 25344335Ruse ND, Sadoun MJ. Resin-composite blocks for dental CAD/CAM applications. J Dent Res. 2014 Dec;93(12):1232-4. doi: 10.1177/0022034514553976. Epub 2014 Oct 24.
- Background: PubMed 30368664Zimmermann M, Ender A, Egli G, Ozcan M, Mehl A. Fracture load of CAD/CAM-fabricated and 3D-printed composite crowns as a function of material thickness. Clin Oral Investig. 2019 Jun;23(6):2777-2784. doi: 10.1007/s00784-018-2717-2. Epub 2018 Oct 27.
- Background: PubMed 27456684Alharbi A, Ardu S, Bortolotto T, Krejci I. Stain susceptibility of composite and ceramic CAD/CAM blocks versus direct resin composites with different resinous matrices. Odontology. 2017 Apr;105(2):162-169. doi: 10.1007/s10266-016-0258-1. Epub 2016 Jul 25.
- Background: PubMed 27928105Kamonwanon P, Hirose N, Yamaguchi S, Sasaki JI, Kitagawa H, Kitagawa R, Thaweboon S, Srikhirin T, Imazato S. SiO2-nanocomposite film coating of CAD/CAM composite resin blocks improves surface hardness and reduces susceptibility to bacterial adhesion. Dent Mater J. 2017 Jan 31;36(1):88-94. doi: 10.4012/dmj.2016-135. Epub 2016 Dec 6.
- Background: PubMed 14620019Mitra SB, Wu D, Holmes BN. An application of nanotechnology in advanced dental materials. J Am Dent Assoc. 2003 Oct;134(10):1382-90. doi: 10.14219/jada.archive.2003.0054.
- Background: PubMed 16987320Deliperi S, Bardwell DN. Clinical evaluation of direct cuspal coverage with posterior composite resin restorations. J Esthet Restor Dent. 2006;18(5):256-65; discussion 266-7. doi: 10.1111/j.1708-8240.2006.00033.x.
- Background: PubMed 18514665Yesil ZD, Alapati S, Johnston W, Seghi RR. Evaluation of the wear resistance of new nanocomposite resin restorative materials. J Prosthet Dent. 2008 Jun;99(6):435-43. doi: 10.1016/S0022-3913(08)60105-5.
- Background: PubMed 28422359Zimmermann M, Koller C, Reymus M, Mehl A, Hickel R. Clinical Evaluation of Indirect Particle-Filled Composite Resin CAD/CAM Partial Crowns after 24 Months. J Prosthodont. 2018 Oct;27(8):694-699. doi: 10.1111/jopr.12582. Epub 2017 Apr 19.
- Background: PubMed 26777092Shembish FA, Tong H, Kaizer M, Janal MN, Thompson VP, Opdam NJ, Zhang Y. Fatigue resistance of CAD/CAM resin composite molar crowns. Dent Mater. 2016 Apr;32(4):499-509. doi: 10.1016/j.dental.2015.12.005. Epub 2016 Jan 8.
- Background: PubMed 21458646Schlichting LH, Maia HP, Baratieri LN, Magne P. Novel-design ultra-thin CAD/CAM composite resin and ceramic occlusal veneers for the treatment of severe dental erosion. J Prosthet Dent. 2011 Apr;105(4):217-26. doi: 10.1016/S0022-3913(11)60035-8.
- 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.
Mutlu Özcan, Prof.Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELS Even Stronger (3D Printed Resin Composite) in people with Composite Resins and Dental Prosthesis, run by Istanbul Medipol University Hospital 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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Aug 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Muzaffer Ateş, Prof. Dr. (+90 212 453 48 00 ext. 4969, mates@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified FDI (World Dental Federation) criteria for dental restoration assessment (time frame: 3 years). 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 NCT04600297, which also lists 17 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 13 Aug 2021.