Sinus PneumatizationNCT03559777
Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome
A study testing closed sinus lifting by Osteotome and closed sinus lifting by Densah bur in people with Sinus Pneumatization, run by Cairo University.
Trial summary
This study is aiming to evaluate primary stability of implant in closed sinus lifting cases by Densah bur in compared to Osteotome in partially edentulous patients hoping that densah bur can lift the sinus membrane and improve primary stability of implant. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Pneumatization
- What is being tested?
- closed sinus lifting by Osteotome and closed sinus lifting by Densah bur
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both males as well as females without any active periodontal disease.
- All patients were in a good health with no systemic diseases.
- All selected patients were non-smokers and non-alcoholics.
- Patient were free from T.M.J troubles, abnormal oral habits such as bruxism.
- The edentulous ridges were covered with optimal thickness of soft tissue.
- Remaining natural teeth had good.
- Periodontal tissue support and occlusion showed sufficient inter arch space.
- On the local level, patients with maxillary sinus diseases and unfavorable inter maxillary relationship were excluded.
Who cannot join
- Patients with residual bone height less than 6mm.
- Patients with systemic disease that may affect bone quality.
- Patients with poor oral hygiene and active periodontal diseases.
- Patient with limited mouth opening.
Trial locations and contacts
No sites are listed yet.
ahmed fahmy, professor contact
About this study
Official title: Evaluation for Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome in Partially Edentulous Patients (A Randomized Clinical Trial)
This study is aiming to evaluate primary stability of implant in closed sinus lifting cases by Densah bur in compared to Osteotome in partially edentulous patients hoping that densah bur can lift the sinus membrane and improve primary stability of implant.
Read the detailed description
The osteotome technique is effective in certain cases, but the most sensitive aspect is the tapping force, which should be sufficient enough to infracture the sinus floor cortical bone but restrained enough to prevent the osteotome tip from traumatizing the Schneiderian membrane.
Several surgical techniques have been proposed to minimize the sinus membrane perforation rate by using a piezosurgical device, balloon, hydrostatic pressure.
The success of therapy in posterior maxilla is not only dependent on the success of the sinus elevation but also the primary stability of the implant that allow bone apposition on the implant surface without any micromovement for osseeointegration.
Later, densah burs are introduced as another treatment option for internal transalveolar approach of sinus floor elevation with improving primary stability of implant by osseodensification.
As treatment options of edentulous maxillary today may include dental implants, the practitioner must be familiar with various sinus lift surgical techniques in order to choose an ideal treatment option for the patient.
- Conditions
- Sinus Pneumatization
- Being tested
- closed sinus lifting by Osteotome, closed sinus lifting by Densah bur
- Keywords
- closed sinus lifiting, implant stability, osteotome, densah bur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed sinus lifting by OsteotomeOther
- Local anesthesia will be injected intra-orally
- A full thickness flap will be elevated
- A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor.
- The widening drills can be sequentially used to widen the osteotomy site to the same level
- An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level.
- The osteotome will be tapped gently to fracture up the sinus floor.
- Xenograft will be added to the osteotomy as the grafting material.
- Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted.
- Smart peg will be placed on implant and Ostell will be used to record ISQ.
- Healing collar will be placed on implant.
- Suturing the flab around healing collar.
closed sinus lifting by Densah burOther
- Local anesthesia will be injected intra-orally
- A full thickness flap will be elevated
- A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor.
- Change the drill motor to reverse- densifying Mode
- with the densah bur (2.5mm) until 1 mm short of the sinus floor.
- Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments.
- densah burs (3.5mm) advance in the osteotomy.
- Xenograft will be added to the osteotomy .
- Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted.
- Smart peg will be placed on implant and Ostell will be used to record ISQ.
- Healing collar will be placed on implant.
- Suturing the flab around healing collar.
| Study group | Role | What they receive |
|---|---|---|
| closed sinus lifting by Osteotome | Active comparator | * Local anesthesia will be injected intra-orally
* A full thickness flap will be elevated
* A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor.
* The widening drills can be sequentially used to widen the osteotomy site to the same level
* An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level.
* The osteotome will be tapped gently to fracture up the sinus floor.
* Xenograft will be added to the osteotomy as the grafting material.
* Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted.
* Smart peg will be placed on implant and Ostell will be used to record ISQ.
* Healing collar will be placed on implant.
* Suturing the flab around healing collar. Receives: Other: closed sinus lifting by Osteotome |
| closed sinus lifting by Densah bur | Experimental | * Local anesthesia will be injected intra-orally
* A full thickness flap will be elevated
* A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor.
* Change the drill motor to reverse- densifying Mode
* Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor.
* Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments.
* densah burs (3.5mm) advance in the osteotomy.
* Xenograft will be added to the osteotomy .
* Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted.
* Smart peg will be placed on implant and Ostell will be used to record ISQ.
* Healing collar will be placed on implant.
* Suturing the flab around healing collar. Receives: Other: closed sinus lifting by Densah bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
stability of implant
After implant placement, Implant stability will be measured by Ostell
Measured: Implant stability will be measured intraoperative at time of surgery
stability of implant
Implant stability will be measured by Ostell
Measured: Implant stability will be measured at second week
stability of implant
Implant stability will be measured by Ostell
Measured: Implant stability will be measured at fourth week
stability of implant
Implant stability will be measured by Ostell
Measured: Implant stability will be measured at the sixth week
stability of implant
Implant stability will be measured by Ostell
Measured: Implant stability will be measured at The eighth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Sinus PneumatizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly divided into 2 equal groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha amer taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559777
- Sponsor's protocol ID
- closed sinus lifiting
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zohrabian VM, Sonick M, Hwang D, Abrahams JJ. Dental Implants. Semin Ultrasound CT MR. 2015 Oct;36(5):415-26. doi: 10.1053/j.sult.2015.09.002. Epub 2015 Sep 12.
PubMed 26589695Atwood DA. Reduction of residual ridges: a major oral disease entity. J Prosthet Dent. 1971 Sep;26(3):266-79. doi: 10.1016/0022-3913(71)90069-2. No abstract available.
PubMed 4934947Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
PubMed 3516738Valentini P, Abensur DJ. Maxillary sinus grafting with anorganic bovine bone: a clinical report of long-term results. Int J Oral Maxillofac Implants. 2003 Jul-Aug;18(4):556-60.
PubMed 12939008Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
PubMed 8055503Pjetursson 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 18724852Chen L, Cha J. An 8-year retrospective study: 1,100 patients receiving 1,557 implants using the minimally invasive hydraulic sinus condensing technique. J Periodontol. 2005 Mar;76(3):482-91. doi: 10.1902/jop.2005.76.3.482.
PubMed 15857085Pietrokovski 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 5224784Bartee BK. Extraction site reconstruction for alveolar ridge preservation. Part 1: rationale and materials selection. J Oral Implantol. 2001;27(4):187-93. doi: 10.1563/1548-1336(2001)0272.3.CO;2.
PubMed 12500877Sharan A, Madjar D. Maxillary sinus pneumatization following extractions: a radiographic study. Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):48-56.
PubMed 18416412Chrcanovic BR, Albrektsson T, Wennerberg A. Reasons for failures of oral implants. J Oral Rehabil. 2014 Jun;41(6):443-76. doi: 10.1111/joor.12157. Epub 2014 Mar 11.
PubMed 24612346Geckili O, Bilhan H, Geckili E, Cilingir A, Mumcu E, Bural C. Evaluation of possible prognostic factors for the success, survival, and failure of dental implants. Implant Dent. 2014 Feb;23(1):44-50. doi: 10.1097/ID.0b013e3182a5d430.
PubMed 24113554Lundgren S, Cricchio G, Hallman M, Jungner M, Rasmusson L, Sennerby L. Sinus floor elevation procedures to enable implant placement and integration: techniques, biological aspects and clinical outcomes. Periodontol 2000. 2017 Feb;73(1):103-120. doi: 10.1111/prd.12165.
PubMed 28000271Schwartz-Arad D, Herzberg R, Dolev E. The prevalence of surgical complications of the sinus graft procedure and their impact on implant survival. J Periodontol. 2004 Apr;75(4):511-6. doi: 10.1902/jop.2004.75.4.511.
PubMed 15152813Tan WC, Lang NP, Zwahlen M, Pjetursson BE. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. Part II: transalveolar technique. J Clin Periodontol. 2008 Sep;35(8 Suppl):241-54. doi: 10.1111/j.1600-051X.2008.01273.x.
PubMed 18724853
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for Primary Stability of Implant in Closed Sinus Lifting Cases Using Densah Bur Versus Osteotome in Partially Edentulous Patients (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03559777
- Acronym / sponsor ID
- closed sinus lifiting
- Conditions
- Sinus Pneumatization
- Keywords
- closed sinus lifiting, implant stability, osteotome, densah bur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 18 Jun 2018 (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 is aiming to evaluate primary stability of implant in closed sinus lifting cases by Densah bur in compared to Osteotome in partially edentulous patients hoping that densah bur can lift the sinus membrane and improve primary stability of implant.
Detailed description
The osteotome technique is effective in certain cases, but the most sensitive aspect is the tapping force, which should be sufficient enough to infracture the sinus floor cortical bone but restrained enough to prevent the osteotome tip from traumatizing the Schneiderian membrane.
Several surgical techniques have been proposed to minimize the sinus membrane perforation rate by using a piezosurgical device, balloon, hydrostatic pressure.
The success of therapy in posterior maxilla is not only dependent on the success of the sinus elevation but also the primary stability of the implant that allow bone apposition on the implant surface without any micromovement for osseeointegration.
Later, densah burs are introduced as another treatment option for internal transalveolar approach of sinus floor elevation with improving primary stability of implant by osseodensification.
As treatment options of edentulous maxillary today may include dental implants, the practitioner must be familiar with various sinus lift surgical techniques in order to choose an ideal treatment option for the patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The patients will be randomly divided into 2 equal groups
| Arm | Type | Receives |
|---|---|---|
| closed sinus lifting by Osteotome | Active comparator | Other: closed sinus lifting by Osteotome* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. * The widening drills can be sequentially used to widen the osteotomy site to the same level * An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level. * The osteotome will be tapped gently to fracture up the sinus floor. * Xenograft will be added to the osteotomy as the grafting material. * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar. |
| closed sinus lifting by Densah bur | Experimental | Other: closed sinus lifting by Densah bur* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor. * Change the drill motor to reverse- densifying Mode * Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor. * Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments. * densah burs (3.5mm) advance in the osteotomy. * Xenograft will be added to the osteotomy . * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both males as well as females without any active periodontal disease.
- All patients were in a good health with no systemic diseases.
- All selected patients were non-smokers and non-alcoholics.
- Patient were free from T.M.J troubles, abnormal oral habits such as bruxism.
- The edentulous ridges were covered with optimal thickness of soft tissue.
Key exclusion criteria (4 listed)
- Patients with residual bone height less than 6mm.
- Patients with systemic disease that may affect bone quality.
- Patients with poor oral hygiene and active periodontal diseases.
- Patient with limited mouth opening.
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 |
|---|---|---|
| closed sinus lifting by Osteotome* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. * The widening drills can be sequentially used to widen the osteotomy site to the same level * An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level. * The osteotome will be tapped gently to fracture up the sinus floor. * Xenograft will be added to the osteotomy as the grafting material. * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar. | Other | closed sinus lifting by Osteotome |
| closed sinus lifting by Densah bur* Local anesthesia will be injected intra-orally * A full thickness flap will be elevated * A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor. * Change the drill motor to reverse- densifying Mode * with the densah bur (2.5mm) until 1 mm short of the sinus floor. * Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments. * densah burs (3.5mm) advance in the osteotomy. * Xenograft will be added to the osteotomy . * Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted. * Smart peg will be placed on implant and Ostell will be used to record ISQ. * Healing collar will be placed on implant. * Suturing the flab around healing collar. | Other | closed sinus lifting by Densah bur |
Primary outcome
stability of implant
Time frame: Implant stability will be measured intraoperative at time of surgery
After implant placement, Implant stability will be measured by Ostell
stability of implant
Time frame: Implant stability will be measured at second week
Implant stability will be measured by Ostell
stability of implant
Time frame: Implant stability will be measured at fourth week
Implant stability will be measured by Ostell
stability of implant
Time frame: Implant stability will be measured at the sixth week
Implant stability will be measured by Ostell
stability of implant
Time frame: Implant stability will be measured at The eighth week
Implant stability will be measured by Ostell
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Background: PubMed 26589695Zohrabian VM, Sonick M, Hwang D, Abrahams JJ. Dental Implants. Semin Ultrasound CT MR. 2015 Oct;36(5):415-26. doi: 10.1053/j.sult.2015.09.002. Epub 2015 Sep 12.
- Background: PubMed 4934947Atwood DA. Reduction of residual ridges: a major oral disease entity. J Prosthet Dent. 1971 Sep;26(3):266-79. doi: 10.1016/0022-3913(71)90069-2. No abstract available.
- Background: PubMed 3516738Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
- Background: PubMed 12939008Valentini P, Abensur DJ. Maxillary sinus grafting with anorganic bovine bone: a clinical report of long-term results. Int J Oral Maxillofac Implants. 2003 Jul-Aug;18(4):556-60.
- Background: PubMed 8055503Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
- Background: 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.
- Background: PubMed 15857085Chen L, Cha J. An 8-year retrospective study: 1,100 patients receiving 1,557 implants using the minimally invasive hydraulic sinus condensing technique. J Periodontol. 2005 Mar;76(3):482-91. doi: 10.1902/jop.2005.76.3.482.
- Background: PubMed 5224784Pietrokovski 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.
- Background: PubMed 12500877Bartee BK. Extraction site reconstruction for alveolar ridge preservation. Part 1: rationale and materials selection. J Oral Implantol. 2001;27(4):187-93. doi: 10.1563/1548-1336(2001)0272.3.CO;2.
- Background: PubMed 18416412Sharan A, Madjar D. Maxillary sinus pneumatization following extractions: a radiographic study. Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):48-56.
- Background: PubMed 24612346Chrcanovic BR, Albrektsson T, Wennerberg A. Reasons for failures of oral implants. J Oral Rehabil. 2014 Jun;41(6):443-76. doi: 10.1111/joor.12157. Epub 2014 Mar 11.
- Background: PubMed 24113554Geckili O, Bilhan H, Geckili E, Cilingir A, Mumcu E, Bural C. Evaluation of possible prognostic factors for the success, survival, and failure of dental implants. Implant Dent. 2014 Feb;23(1):44-50. doi: 10.1097/ID.0b013e3182a5d430.
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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.
ahmed fahmy, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing closed sinus lifting by Osteotome and closed sinus lifting by Densah bur in people with Sinus Pneumatization, 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 8 inclusion and 4 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 18 Jun 2018. 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 taha amer, master (+201095896951, tahaamer181290@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stability of implant (time frame: Implant stability will be measured intraoperative at time of surgery). The study lists 5 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 NCT03559777, which also lists 22 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 18 Jun 2018.