Alveolar Bone LossNCT03958448
Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation.
A study testing Placement of extra short implants, maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation and placement of standard implant in people with Alveolar Bone Loss, run by ARDEC Academy.
Trial summary
Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Placement of extra short implants, maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation and placement of standard implant
- 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
- 1 Oct 2015to 2 Apr 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Edentulous maxilla
- Willing to receive a full arch fixed restoration in the maxilla.
- Latest extraction at least 8 weeks before implant insertion
- Sinus floor height included between 4 to 6 mm
- Bone width in the distal segments sufficient to allow the insertion of a 4 mm long implant of standard diameter.
- In the anterior maxilla (from first premolar to first premolar) bone width sufficient to allow the insertion of 10 mm long implants of standard diameter. Minor horizontal augmentations with guided bone regeneration procedures was allowed in the anterior maxilla.
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- the opposing arch have to present one of the following conditions:
- natural dentition (at least 10 elements from 3.5 to 4.5)
- Fixed dental prosthesis of at least 10 elements (from 3.5 to 4.5) supported by teeth or implants
- Implant supported or teeth supported overdentures
- Adequate partial removable prostheses.
Who cannot join
- Presence of conditions requiring prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements).
- Major systemic diseases, or medical conditions requiring prolonged use of steroids, or alcoholism or chronically drug abuse.
- Current pregnancy or breastfeeding women
- Smokers > 10 cigarettes per day
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Immunocompromised patients including patients infected with HIV
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- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
- Patients with an ongoing or previous treatment with bisphosphonates (for at least 2 months for oral therapy or 6 months for IV injection)
- Local exclusion criteria
- Local inflammation, including untreated periodontitis
- Pre-cancerous oral lesions
- History of local irradiation therapy
- Severe bruxism or clenching habits
- Patients with inadequate oral hygiene or unmotivated for adequate oral home care
- Previous Guided bone regeneration or Guided tissue regeneration treatment at the implant site
- Total removable prosthesis in the lower arch
About this study
Official title: Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation. A Randomized Clinical Trial
Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the maxilla have not been published yet. The aim of the present study will be to compare the survival and success rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure
Read the detailed description
Two groups will be randomly prepared, the Short group and the Standard group. In the Short group, one 4 mm long and 4.1 mm in diameter implant (extra-short implant) will be installed in each side of the posterior region of the maxilla. In the Standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (standard implant) will be installed into each augmented sinus. In the frontal region, four 10 mm long implants will be installed in both groups. Clinical assessments and x-rays will be taken at prosthesis delivering (6-8 weeks after implant installation), and after 6, 12, 18 and 24 months.
- Conditions
- Alveolar Bone Loss
- Being tested
- Placement of extra short implants, maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation, placement of standard implant
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of extra short implantsProcedure or surgery
placement of an extra short implant in the posterior edentulous ridge
maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentationProcedure or surgery
placement of standard implantProcedure or surgery
placement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation
| Study group | Role | What they receive |
|---|---|---|
| Short Group | Experimental | In each side of the posterior region of the maxilla, one tissue level implant, 4 mm long and 4.1 mm in diameter, will be installed Receives: Procedure: Placement of extra short implants |
| Standard group | Experimental | sinus floor elevation with will be performed using natural bovine bone graft as filler material and porcine dermis collagen membrane to cover the antrostomy. After 4 months of healing, one bone level implant, 10 mm long and 4.1 mm in diameter, will be installed into each augmented sinus. Receives: Procedure: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation; Procedure: placement of standard implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate of 4 mm implants used as distal support
To compare the survival rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure.
Measured: 24 months
Crestal bone level
Change of crestal bone level measured on intraoral x-ray applying a parallel technique from baseline (definitive prosthesis delivering) and 2-year follow-up. The distance between the implant margin and the first bone to implant contact will be measured in millimeters at the mesial and distal aspects of the Short and Standard implants.
Measured: 24 months
Secondary outcomes (1)
Technical complications
Any technical complications related to implants, abutments, screw loosening, prosthetic fracture or chipping of the veneer material expressed in number of occurrence.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Oct 2015
- Primary completion2 Dec 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be randomly prepared. The Short group, one 4 mm long and 4.1 mm in diameter implant (Short implant) will be installed in each side of the posterior region of the maxilla. The standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (Standard implant) will be installed into each augmented sinus.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARDEC Academy
- Sponsor type
- Research network
- Collaborators
- University of Bologna, ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958448
- Sponsor's protocol ID
- protocol #15052
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
PubMed 18724852Barone A, Ricci M, Grassi RF, Nannmark U, Quaranta A, Covani U. A 6-month histological analysis on maxillary sinus augmentation with and without use of collagen membranes over the osteotomy window: randomized clinical trial. Clin Oral Implants Res. 2013 Jan;24(1):1-6. doi: 10.1111/j.1600-0501.2011.02340.x. Epub 2011 Dec 12.
PubMed 22151577Masuda K, Silva ER, Botticelli D, Apaza Alccayhuaman KA, Xavier SP. Antrostomy Preparation for Maxillary Sinus Floor Augmentation Using Drills or a Sonic Instrument: A Microcomputed Tomography and Histomorphometric Study in Rabbits. Int J Oral Maxillofac Implants. 2019 July/August;34(4):819-827. doi: 10.11607/jomi.7350. Epub 2019 Feb 15.
PubMed 30768660Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
PubMed 15726851Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x.
PubMed 21906186Moon YS, Sohn DS, Moon JW, Lee JH, Park IS, Lee JK. Comparative histomorphometric analysis of maxillary sinus augmentation with absorbable collagen membrane and osteoinductive replaceable bony window in rabbits. Implant Dent. 2014 Feb;23(1):29-36. doi: 10.1097/ID.0000000000000031.
PubMed 24445918Omori Y, Ricardo Silva E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Reposition of the bone plate over the antrostomy in maxillary sinus augmentation: A histomorphometric study in rabbits. Clin Oral Implants Res. 2018 Aug;29(8):821-834. doi: 10.1111/clr.13292. Epub 2018 Jun 7.
PubMed 29876969Corbella S, Taschieri S, Weinstein R, Del Fabbro M. Histomorphometric outcomes after lateral sinus floor elevation procedure: a systematic review of the literature and meta-analysis. Clin Oral Implants Res. 2016 Sep;27(9):1106-22. doi: 10.1111/clr.12702. Epub 2015 Oct 10.
PubMed 26452326Caneva M, Lang NP, Garcia Rangel IJ, Ferreira S, Caneva M, De Santis E, Botticelli D. Sinus mucosa elevation using Bio-Oss(R) or Gingistat(R) collagen sponge: an experimental study in rabbits. Clin Oral Implants Res. 2017 Jul;28(7):e21-e30. doi: 10.1111/clr.12850. Epub 2016 Apr 15.
PubMed 27080163De Santis E, Lang NP, Ferreira S, Rangel Garcia I Jr, Caneva M, Botticelli D. Healing at implants installed concurrently to maxillary sinus floor elevation with Bio-Oss(R) or autologous bone grafts. A histo-morphometric study in rabbits. Clin Oral Implants Res. 2017 May;28(5):503-511. doi: 10.1111/clr.12825. Epub 2016 Mar 10.
PubMed 26969193Riachi F, Naaman N, Tabarani C, Aboelsaad N, Aboushelib MN, Berberi A, Salameh Z. Influence of material properties on rate of resorption of two bone graft materials after sinus lift using radiographic assessment. Int J Dent. 2012;2012:737262. doi: 10.1155/2012/737262. Epub 2012 Jul 31.
PubMed 22899930Shanbhag S, Shanbhag V, Stavropoulos A. Volume changes of maxillary sinus augmentations over time: a systematic review. Int J Oral Maxillofac Implants. 2014 Jul-Aug;29(4):881-92. doi: 10.11607/jomi.3472.
PubMed 25032768Zijderveld SA, van den Bergh JP, Schulten EA, ten Bruggenkate CM. Anatomical and surgical findings and complications in 100 consecutive maxillary sinus floor elevation procedures. J Oral Maxillofac Surg. 2008 Jul;66(7):1426-38. doi: 10.1016/j.joms.2008.01.027.
PubMed 18571027
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extra-short (4 mm) Implants Used as Distal Support of a Maxillary Full-arch Fixed Dental Prosthesis vs. 10 mm Implants Installed After Sinus Floor Elevation. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03958448
- Acronym / sponsor ID
- protocol #15052
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ARDEC AcademyResearch network
- Collaborators
- University of Bologna, ITI International Team for Implantology, Switzerland
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 22 May 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.
Recently, 4 mm long implants with a standard diameter have been used for the restoration of the posterior edentulous mandible with favorable results. However, randomized clinical trials reporting the results from full-arch fixed dental prosthesis that included 4 mm long implants placed in the posterior regions of the maxilla have not been published yet. The aim of the present study will be to compare the survival and success rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure
Detailed description
Two groups will be randomly prepared, the Short group and the Standard group. In the Short group, one 4 mm long and 4.1 mm in diameter implant (extra-short implant) will be installed in each side of the posterior region of the maxilla. In the Standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (standard implant) will be installed into each augmented sinus. In the frontal region, four 10 mm long implants will be installed in both groups. Clinical assessments and x-rays will be taken at prosthesis delivering (6-8 weeks after implant installation), and after 6, 12, 18 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups will be randomly prepared. The Short group, one 4 mm long and 4.1 mm in diameter implant (Short implant) will be installed in each side of the posterior region of the maxilla. The standard group, bilateral sinus floor elevations will be performed. After 4 months of healing, one 10 mm long and 4.1 mm in diameter implant (Standard implant) will be installed into each augmented sinus.
| Arm | Type | Receives |
|---|---|---|
| Short Group | Experimental | Procedure: Placement of extra short implantsIn each side of the posterior region of the maxilla, one tissue level implant, 4 mm long and 4.1 mm in diameter, will be installed |
| Standard group | Experimental | Procedure: maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation, Procedure: placement of standard implantsinus floor elevation with will be performed using natural bovine bone graft as filler material and porcine dermis collagen membrane to cover the antrostomy. After 4 months of healing, one bone level implant, 10 mm long and 4.1 mm in diameter, will be installed into each augmented sinus. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Edentulous maxilla
- Willing to receive a full arch fixed restoration in the maxilla.
- Latest extraction at least 8 weeks before implant insertion
- Sinus floor height included between 4 to 6 mm
- Bone width in the distal segments sufficient to allow the insertion of a 4 mm long implant of standard diameter.
Key exclusion criteria (16 listed)
- Presence of conditions requiring prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements).
- Major systemic diseases, or medical conditions requiring prolonged use of steroids, or alcoholism or chronically drug abuse.
- Current pregnancy or breastfeeding women
- Smokers > 10 cigarettes per day
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
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 |
|---|---|---|
| Placement of extra short implantsplacement of an extra short implant in the posterior edentulous ridge | Procedure or surgery | Short Group |
| maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation | Procedure or surgery | Standard group |
| placement of standard implantplacement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation | Procedure or surgery | Standard group |
Primary outcome
survival rate of 4 mm implants used as distal support
Time frame: 24 months
To compare the survival rates of 4 mm implants used as distal support of a maxillary full-arch fixed dental prosthesis with standard (10 mm) implants placed in association with a bilateral sinus floor augmentation procedure.
Crestal bone level
Time frame: 24 months
Change of crestal bone level measured on intraoral x-ray applying a parallel technique from baseline (definitive prosthesis delivering) and 2-year follow-up. The distance between the implant margin and the first bone to implant contact will be measured in millimeters at the mesial and distal aspects of the Short and Standard implants.
1 secondary outcome
Technical complications
Time frame: 24 months
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 22 May 2019.
- Results publication: PubMed 18724852Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
- Results publication: PubMed 22151577Barone A, Ricci M, Grassi RF, Nannmark U, Quaranta A, Covani U. A 6-month histological analysis on maxillary sinus augmentation with and without use of collagen membranes over the osteotomy window: randomized clinical trial. Clin Oral Implants Res. 2013 Jan;24(1):1-6. doi: 10.1111/j.1600-0501.2011.02340.x. Epub 2011 Dec 12.
- Results publication: PubMed 30768660Masuda K, Silva ER, Botticelli D, Apaza Alccayhuaman KA, Xavier SP. Antrostomy Preparation for Maxillary Sinus Floor Augmentation Using Drills or a Sonic Instrument: A Microcomputed Tomography and Histomorphometric Study in Rabbits. Int J Oral Maxillofac Implants. 2019 July/August;34(4):819-827. doi: 10.11607/jomi.7350. Epub 2019 Feb 15.
- Results publication: PubMed 15726851Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73.
- Results publication: PubMed 21906186Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x.
- Results publication: PubMed 24445918Moon YS, Sohn DS, Moon JW, Lee JH, Park IS, Lee JK. Comparative histomorphometric analysis of maxillary sinus augmentation with absorbable collagen membrane and osteoinductive replaceable bony window in rabbits. Implant Dent. 2014 Feb;23(1):29-36. doi: 10.1097/ID.0000000000000031.
- Results publication: PubMed 29876969Omori Y, Ricardo Silva E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Reposition of the bone plate over the antrostomy in maxillary sinus augmentation: A histomorphometric study in rabbits. Clin Oral Implants Res. 2018 Aug;29(8):821-834. doi: 10.1111/clr.13292. Epub 2018 Jun 7.
- Results publication: PubMed 26452326Corbella S, Taschieri S, Weinstein R, Del Fabbro M. Histomorphometric outcomes after lateral sinus floor elevation procedure: a systematic review of the literature and meta-analysis. Clin Oral Implants Res. 2016 Sep;27(9):1106-22. doi: 10.1111/clr.12702. Epub 2015 Oct 10.
- Results publication: PubMed 27080163Caneva M, Lang NP, Garcia Rangel IJ, Ferreira S, Caneva M, De Santis E, Botticelli D. Sinus mucosa elevation using Bio-Oss(R) or Gingistat(R) collagen sponge: an experimental study in rabbits. Clin Oral Implants Res. 2017 Jul;28(7):e21-e30. doi: 10.1111/clr.12850. Epub 2016 Apr 15.
- Results publication: PubMed 26969193De Santis E, Lang NP, Ferreira S, Rangel Garcia I Jr, Caneva M, Botticelli D. Healing at implants installed concurrently to maxillary sinus floor elevation with Bio-Oss(R) or autologous bone grafts. A histo-morphometric study in rabbits. Clin Oral Implants Res. 2017 May;28(5):503-511. doi: 10.1111/clr.12825. Epub 2016 Mar 10.
- Results publication: PubMed 22899930Riachi F, Naaman N, Tabarani C, Aboelsaad N, Aboushelib MN, Berberi A, Salameh Z. Influence of material properties on rate of resorption of two bone graft materials after sinus lift using radiographic assessment. Int J Dent. 2012;2012:737262. doi: 10.1155/2012/737262. Epub 2012 Jul 31.
- Results publication: PubMed 25032768Shanbhag S, Shanbhag V, Stavropoulos A. Volume changes of maxillary sinus augmentations over time: a systematic review. Int J Oral Maxillofac Implants. 2014 Jul-Aug;29(4):881-92. doi: 10.11607/jomi.3472.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of extra short implants, maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation and placement of standard implant in people with Alveolar Bone Loss, run by ARDEC Academy.
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 16 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 22 May 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?
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?
survival rate of 4 mm implants used as distal support (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT03958448, which also lists 13 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 22 May 2019.