Alveolar Bone ResorptionNCT04022538
Evaluation of Vertical Height in Anterior Maxillary Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement
A study testing Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement and Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation in people with Alveolar Bone Resorption, run by Cairo University.
Trial summary
Vertical bone height has always presented challenge for the clinicians especially in the anterior aesthetic zone. Therefore, this trial will attempt to compare whether better vertical bone height and implant placement technique can be achieved using simultaneous implant placement with the sandwich osteotomy, which is… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement and Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Aug 2020
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range from 20-55 years. No sex predilection.
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous anterior maxilla with vertically deficient alveolar ridge that is less than 10 mm measured from the crest of the alveolar ridge to the nasal floor.
- Normal vertical dimension with increased inter-arch space.
- The minimum number of missing teeth in the anterior maxillary alveolar ridge is two adjacent anterior teeth.
Who cannot join
- • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area.
- Deficient horizontal dimensions of the alveolar ridge i.e. width is less than 5 mm.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Vertical Bone Augmentation Using Anterior Maxillary Segmental Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement, A Randomized Controlled Trial
Vertical bone height has always presented challenge for the clinicians especially in the anterior aesthetic zone. Therefore, this trial will attempt to compare whether better vertical bone height and implant placement technique can be achieved using simultaneous implant placement with the sandwich osteotomy, which is a time saving procedure performed in a single stage surgery; when compared to using fixation plates to support the segment followed by delayed implant placement.
Read the detailed description
Fixation plates are usually used to support the segmentalized bone segment during vertical bone augmentation using sandwich osteotomy and inlay bone grafting; to minimize movement of the bone segment and allow for new bone formation. Therefore, the aim of this study is to evaluate vertical bone height achieved at the anterior maxilla in vertical segmental sandwich osteotomy with simultaneous implant placement versus the same technique using fixation plates.
Description of Sandwich Osteotomy procedure to be done:
- A full thickness pyramidal flap with buccal paracrestal incision and two vertical releasing incisions slightly divergent to each other will be made. Then the mucoperiosteal flap will be reflected exposing the whole buccal cortical plate without reflection of the palatal mucosa.
- The palatal mucosa will not be reflected to avoid disturbance of blood supply to the mobilized segment for proper healing.
- With a Tungsten carbide disc - 1 mm in thickness and 10 mm in diameter - the alveolar bone will be segmented using a horizontal cut 3 to 5 mm apical to the crest of the ridge, and two lateral vertically oblique cuts 1-2 mm away from adjacent teeth roots slightly converging toward the alveolar crest or almost parallel to each other; thus creating a trapezoid-shaped bone segment pedicled on the attached palatal tissues.
- The horizontal and the two vertical cuts will then be revised using a set of graduated ridge splitting (fine chisels) osteotomes of sequential width and a light weight mallet to ensure that the surgical cuts are down to spongy bone.
- The segment will then be mobilized crestally, pedicled on the non-reflected palatal tissue.
- Conditions
- Alveolar Bone Resorption
- Being tested
- Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement, Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation
- Keywords
- Vertical bone augmentation, Inlay bone graft, Dental Implants, Sandwich Osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placementProcedure or surgery
Also called Inlay alveolar bone grafting with simultaneous implant placement
Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:
- The first implant osteotomy will be prepared and placed while a chisel is placed between the down fractured segment and the basal bone, and then the second implant will be installed.
- The gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
- Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.
Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixationProcedure or surgery
Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:
- The created gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
- The mobilized segment is to be fixed to the basal bone using micro-plates and micro-screws.
- Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material.
| Study group | Role | What they receive |
|---|---|---|
| Sandwich osteotomy with simultaneous implant placement | Experimental | This group will undergo Sandwich osteotomy procedure and segment will be fixed using the dental implants placed simultaneously during the same surgical procedure. The remaining gap will be filled using xenograft. Receives: Procedure: Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement |
| Sandwich osteotomy using micro-plates fixation | Active comparator | This group will undergo Sandwich osteotomy procedure and segment will be fixed using micro-plates and screws, and the gap will be filled using xenograft. Receives: Procedure: Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Vertical Alveolar ridge height
Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography
Measured: 4 months postoperatively
Secondary outcomes (1)
Patient Satisfaction: scale from 1 to 10
Measured on a scale from 1 to 10
Measured: 4 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Ali Abdulkhaleq Al-dubai, Cairo University
- Investigators
- Mohammed Aldubai, Principal investigator, Master's Degree Candidate at Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022538
- Sponsor's protocol ID
- CEBD-CU-2019-05-27
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bashutski JD, Wang HL. Common implant esthetic complications. Implant Dent. 2007 Dec;16(4):340-8. doi: 10.1097/ID.0b013e318159ca05.
PubMed 18091161Carlsson GE, Bergman B, Hedegard B. Changes in contour of the maxillary alveolar process under immediate dentures. A longitudinal clinical and x-ray cephalometric study covering 5 years. Acta Odontol Scand. 1967 Jun;25(1):45-75. doi: 10.3109/00016356709072522. No abstract available.
PubMed 5233859El Hadidy MS, Mounir M, Abou-Elfetouh A, Barakat A. Assessment of vertical ridge augmentation and labial prominence using buccal versus palatal approaches for maxillary segmental sandwich osteotomy (inlay technique): A randomized clinical trial. Clin Implant Dent Relat Res. 2018 Oct;20(5):722-728. doi: 10.1111/cid.12653. Epub 2018 Jul 18.
PubMed 30019829Esposito M, Grusovin MG, Kwan S, Worthington HV, Coulthard P. Interventions for replacing missing teeth: bone augmentation techniques for dental implant treatment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD003607. doi: 10.1002/14651858.CD003607.pub3.
PubMed 18646092Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Jensen OT, Kuhlke L, Bedard JF, White D. Alveolar segmental sandwich osteotomy for anterior maxillary vertical augmentation prior to implant placement. J Oral Maxillofac Surg. 2006 Feb;64(2):290-6. doi: 10.1016/j.joms.2005.10.021.
PubMed 16413903Kahnberg KE, Nystrom E, Bartholdsson L. Combined use of bone grafts and Branemark fixtures in the treatment of severely resorbed maxillae. Int J Oral Maxillofac Implants. 1989 Winter;4(4):297-304.
PubMed 2639859Keestra JA, Barry O, Jong Ld, Wahl G. Long-term effects of vertical bone augmentation: a systematic review. J Appl Oral Sci. 2016 Jan-Feb;24(1):3-17. doi: 10.1590/1678-775720150357.
PubMed 27008252Laviv A, Jensen OT, Tarazi E, Casap N. Alveolar sandwich osteotomy in resorbed alveolar ridge for dental implants: a 4-year prospective study. J Oral Maxillofac Surg. 2014 Feb;72(2):292-303. doi: 10.1016/j.joms.2013.09.036. Epub 2013 Oct 5.
PubMed 24321312Lim G, Lin GH, Monje A, Chan HL, Wang HL. Wound Healing Complications Following Guided Bone Regeneration for Ridge Augmentation: A Systematic Review and Meta-Analysis. Int J Oral Maxillofac Implants. 2018 January/February;33(1):41-50. doi: 10.11607/jomi.5581. Epub 2017 Sep 22.
PubMed 28938030Mansour HH, Badr A, Osman AH, Atef M. Anterior maxillary sandwich osteotomy technique with simultaneous implant placement: A novel approach for management of vertical deficiency. Clin Implant Dent Relat Res. 2019 Feb;21(1):160-168. doi: 10.1111/cid.12687. Epub 2018 Nov 9.
PubMed 30411842Milinkovic I, Cordaro L. Are there specific indications for the different alveolar bone augmentation procedures for implant placement? A systematic review. Int J Oral Maxillofac Surg. 2014 May;43(5):606-25. doi: 10.1016/j.ijom.2013.12.004. Epub 2014 Jan 19.
PubMed 24451333Mounir M, Mounir S, Abou-Elfetouh A, Shaker MA. Assessment of vertical ridge augmentation in anterior aesthetic zone using onlay xenografts with titanium mesh versus the inlay bone grafting technique: A randomized clinical trial. Int J Oral Maxillofac Surg. 2017 Nov;46(11):1458-1465. doi: 10.1016/j.ijom.2017.04.021. Epub 2017 May 16.
PubMed 28526551Nkenke E, Neukam FW. Autogenous bone harvesting and grafting in advanced jaw resorption: morbidity, resorption and implant survival. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S203-17.
PubMed 24977256Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.
PubMed 5224784
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vertical Bone Augmentation Using Anterior Maxillary Segmental Sandwich Osteotomy: Simultaneous Versus Delayed Implant Placement, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04022538
- Acronym / sponsor ID
- CEBD-CU-2019-05-27
- Conditions
- Alveolar Bone Resorption
- Keywords
- Vertical bone augmentation, Inlay bone graft, Dental Implants, Sandwich Osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 17 Jul 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.
Vertical bone height has always presented challenge for the clinicians especially in the anterior aesthetic zone. Therefore, this trial will attempt to compare whether better vertical bone height and implant placement technique can be achieved using simultaneous implant placement with the sandwich osteotomy, which is a time saving procedure performed in a single stage surgery; when compared to using fixation plates to support the segment followed by delayed implant placement.
Detailed description
Fixation plates are usually used to support the segmentalized bone segment during vertical bone augmentation using sandwich osteotomy and inlay bone grafting; to minimize movement of the bone segment and allow for new bone formation. Therefore, the aim of this study is to evaluate vertical bone height achieved at the anterior maxilla in vertical segmental sandwich osteotomy with simultaneous implant placement versus the same technique using fixation plates.
Description of Sandwich Osteotomy procedure to be done:
- A full thickness pyramidal flap with buccal paracrestal incision and two vertical releasing incisions slightly divergent to each other will be made. Then the mucoperiosteal flap will be reflected exposing the whole buccal cortical plate without reflection of the palatal mucosa.
- The palatal mucosa will not be reflected to avoid disturbance of blood supply to the mobilized segment for proper healing.
- With a Tungsten carbide disc - 1 mm in thickness and 10 mm in diameter - the alveolar bone will be segmented using a horizontal cut 3 to 5 mm apical to the crest of the ridge, and two lateral vertically oblique cuts 1-2 mm away from adjacent teeth roots slightly converging toward the alveolar crest or almost parallel to each other; thus creating a trapezoid-shaped bone segment pedicled on the attached palatal tissues.
- The horizontal and the two vertical cuts will then be revised using a set of graduated ridge splitting (fine chisels) osteotomes of sequential width and a light weight mallet to ensure that the surgical cuts are down to spongy bone.
- The segment will then be mobilized crestally, pedicled on the non-reflected palatal tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sandwich osteotomy with simultaneous implant placement | Experimental | Procedure: Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placementThis group will undergo Sandwich osteotomy procedure and segment will be fixed using the dental implants placed simultaneously during the same surgical procedure. The remaining gap will be filled using xenograft. |
| Sandwich osteotomy using micro-plates fixation | Active comparator | Procedure: Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixationThis group will undergo Sandwich osteotomy procedure and segment will be fixed using micro-plates and screws, and the gap will be filled using xenograft. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range from 20-55 years. No sex predilection.
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Edentulous anterior maxilla with vertically deficient alveolar ridge that is less than 10 mm measured from the crest of the alveolar ridge to the nasal floor.
- Normal vertical dimension with increased inter-arch space.
- The minimum number of missing teeth in the anterior maxillary alveolar ridge is two adjacent anterior teeth.
Key exclusion criteria (3 listed)
- • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area.
- Deficient horizontal dimensions of the alveolar ridge i.e. width is less than 5 mm.
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 |
|---|---|---|
| Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placementAlso: Inlay alveolar bone grafting with simultaneous implant placementFollowing the Sandwich Osteotomy procedure described in the study description, the following steps will be done: * The first implant osteotomy will be prepared and placed while a chisel is placed between the down fractured segment and the basal bone, and then the second implant will be installed. * The gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute. * Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material. | Procedure or surgery | Sandwich osteotomy with simultaneous implant placement |
| Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixationFollowing the Sandwich Osteotomy procedure described in the study description, the following steps will be done: * The created gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute. * The mobilized segment is to be fixed to the basal bone using micro-plates and micro-screws. * Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material. | Procedure or surgery | Sandwich osteotomy using micro-plates fixation |
Primary outcome
Final Vertical Alveolar ridge height
Time frame: 4 months postoperatively
Measured in millimeters from the crest of the alveolar ridge to the floor of nasal cavity using cone-beam computed tomography
1 secondary outcome
Patient Satisfaction: scale from 1 to 10
Time frame: 4 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 18091161Bashutski JD, Wang HL. Common implant esthetic complications. Implant Dent. 2007 Dec;16(4):340-8. doi: 10.1097/ID.0b013e318159ca05.
- Background: PubMed 5233859Carlsson GE, Bergman B, Hedegard B. Changes in contour of the maxillary alveolar process under immediate dentures. A longitudinal clinical and x-ray cephalometric study covering 5 years. Acta Odontol Scand. 1967 Jun;25(1):45-75. doi: 10.3109/00016356709072522. No abstract available.
- Background: PubMed 30019829El Hadidy MS, Mounir M, Abou-Elfetouh A, Barakat A. Assessment of vertical ridge augmentation and labial prominence using buccal versus palatal approaches for maxillary segmental sandwich osteotomy (inlay technique): A randomized clinical trial. Clin Implant Dent Relat Res. 2018 Oct;20(5):722-728. doi: 10.1111/cid.12653. Epub 2018 Jul 18.
- Background: PubMed 18646092Esposito M, Grusovin MG, Kwan S, Worthington HV, Coulthard P. Interventions for replacing missing teeth: bone augmentation techniques for dental implant treatment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD003607. doi: 10.1002/14651858.CD003607.pub3.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 16413903Jensen OT, Kuhlke L, Bedard JF, White D. Alveolar segmental sandwich osteotomy for anterior maxillary vertical augmentation prior to implant placement. J Oral Maxillofac Surg. 2006 Feb;64(2):290-6. doi: 10.1016/j.joms.2005.10.021.
- Background: PubMed 2639859Kahnberg KE, Nystrom E, Bartholdsson L. Combined use of bone grafts and Branemark fixtures in the treatment of severely resorbed maxillae. Int J Oral Maxillofac Implants. 1989 Winter;4(4):297-304.
- Background: PubMed 27008252Keestra JA, Barry O, Jong Ld, Wahl G. Long-term effects of vertical bone augmentation: a systematic review. J Appl Oral Sci. 2016 Jan-Feb;24(1):3-17. doi: 10.1590/1678-775720150357.
- Background: PubMed 24321312Laviv A, Jensen OT, Tarazi E, Casap N. Alveolar sandwich osteotomy in resorbed alveolar ridge for dental implants: a 4-year prospective study. J Oral Maxillofac Surg. 2014 Feb;72(2):292-303. doi: 10.1016/j.joms.2013.09.036. Epub 2013 Oct 5.
- Background: PubMed 28938030Lim G, Lin GH, Monje A, Chan HL, Wang HL. Wound Healing Complications Following Guided Bone Regeneration for Ridge Augmentation: A Systematic Review and Meta-Analysis. Int J Oral Maxillofac Implants. 2018 January/February;33(1):41-50. doi: 10.11607/jomi.5581. Epub 2017 Sep 22.
- Background: PubMed 30411842Mansour HH, Badr A, Osman AH, Atef M. Anterior maxillary sandwich osteotomy technique with simultaneous implant placement: A novel approach for management of vertical deficiency. Clin Implant Dent Relat Res. 2019 Feb;21(1):160-168. doi: 10.1111/cid.12687. Epub 2018 Nov 9.
- Background: PubMed 24451333Milinkovic I, Cordaro L. Are there specific indications for the different alveolar bone augmentation procedures for implant placement? A systematic review. Int J Oral Maxillofac Surg. 2014 May;43(5):606-25. doi: 10.1016/j.ijom.2013.12.004. Epub 2014 Jan 19.
- 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.
Mohammed Aldubai principal investigator
Master's Degree Candidate at Faculty of Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement and Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation in people with Alveolar Bone Resorption, run by Cairo University.
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 3 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 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Evidence-based Dentistry Committe at OMFS dept. (+201001932020, surgeryeb@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Vertical Alveolar ridge height (time frame: 4 months postoperatively). 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 NCT04022538, which also lists 23 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 17 Jul 2019.