Dental PlaqueNCT04853745
The Effect of Air Polishing on the Tooth Surface
An observational study of Dental Plaque, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The use of air-polishing device that operates by directing a fine slurry of pressurized air, water, and abrasive particles has become widespread in dentistry for polishing. The introduction of abrasive powders with different properties creates the need to evaluate the effects of these powders on dental hard tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Plaque
- What is being tested?
- AIR-FLOW® Master Piezon
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2019to 14 Sep 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry.
Who may be able to join
- Being older than age of 18,
- Willing to participate the study,
- To have a single rooted tooth with gingival recession on all surfaces and need to be extracted,
- The tooth has to be free of caries, defects and restorations.
Who cannot join
- Have history of infectious diseases like Hepatitis and/or HIV (+).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University, Faculty of Dentistry
Kocaeli
About this study
Official title: Analyzing the Effect of Different Polishing Materials on Different Dental Tissues by Micro-Computed Tomography
The use of air-polishing device that operates by directing a fine slurry of pressurized air, water, and abrasive particles has become widespread in dentistry for polishing. The introduction of abrasive powders with different properties creates the need to evaluate the effects of these powders on dental hard tissues. This study was focused on the effect of sodium bicarbonate, glycine and erythritol air polishing on enamel and exposed root surface.
Read the detailed description
The aim of this study is to evaluate the effect of sodium bicarbonate, glycine and erythritol air polishing on enamel and exposed root surface. Forty eight single root extracted teeth were included into the study. The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect depth, defect volume, demineralization depth and mineral density values were estimated.
- Conditions
- Dental Plaque
- Being tested
- AIR-FLOW® Master Piezon
- Keywords
- glycine, erythritol, sodium bicarbonate, x-ray microtomography, gingival recession, air abrasion
- Medical subject headings
- Dental Plaque, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIR-FLOW® Master PiezonDevice
AIR-FLOW® Master Piezon is intended for use in the cleaning and polishing of teeth by the projection of water,air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. This air polishing device was used for all powder instrumentations.
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate group | Sodium bicarbonate-based powder (CLASSIC®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application. Receives: Device: AIR-FLOW® Master Piezon | |
| glycine group | Glycine-based powder (PERIO®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application. Receives: Device: AIR-FLOW® Master Piezon | |
| erythritol group | Erythritol-based powder (PLUS®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application. Receives: Device: AIR-FLOW® Master Piezon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defect depth
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect depth was estimated.
Measured: 5 second
Demineralization depth
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the demineralization depth was estimated.
Measured: 5 second
Mineral density
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5 mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the mineral density was estimated.
Measured: 10 second
Defect volume
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect volume was estimated.
Measured: 5 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start24 Jul 2019
- Primary completion27 Jul 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vecihe Merve Balta Uysal, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853745
- Sponsor's protocol ID
- KOU GOKAEK 2019/10.34
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Petersilka GJ. Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontol 2000. 2011 Feb;55(1):124-42. doi: 10.1111/j.1600-0757.2010.00342.x. No abstract available.
PubMed 21134232Graumann SJ, Sensat ML, Stoltenberg JL. Air polishing: a review of current literature. J Dent Hyg. 2013 Aug;87(4):173-80.
PubMed 23986410Gutmann ME. Air polishing: a comprehensive review of the literature. J Dent Hyg. 1998 Summer;72(3):47-56.
PubMed 9693568Weaks LM, Lescher NB, Barnes CM, Holroyd SV. Clinical evaluation of the Prophy-Jet as an instrument for routine removal of tooth stain and plaque. J Periodontol. 1984 Aug;55(8):486-8. doi: 10.1902/jop.1984.55.8.486.
PubMed 6592321Berkstein S, Reiff RL, McKinney JF, Killoy WJ. Supragingival root surface removal during maintenance procedures utilizing an air-powder abrasive system or hand scaling. An in vitro study. J Periodontol. 1987 May;58(5):327-30. doi: 10.1902/jop.1987.58.5.327.
PubMed 3295185Barnes CM, Russell CM, Gerbo LR, Wells BR, Barnes DW. Effects of an air-powder polishing system on orthodontically bracketed and banded teeth. Am J Orthod Dentofacial Orthop. 1990 Jan;97(1):74-81. doi: 10.1016/S0889-5406(05)81712-3. No abstract available.
PubMed 2136972Kontturi-Narhi V, Markkanen S, Markkanen H. Effects of airpolishing on dental plaque removal and hard tissues as evaluated by scanning electron microscopy. J Periodontol. 1990 Jun;61(6):334-8. doi: 10.1902/jop.1990.61.6.334.
PubMed 2366141Atkinson DR, Cobb CM, Killoy WJ. The effect of an air-powder abrasive system on in vitro root surfaces. J Periodontol. 1984 Jan;55(1):13-8. doi: 10.1902/jop.1984.55.1.13.
PubMed 6319658Barnes CM, Covey D, Watanabe H, Simetich B, Schulte JR, Chen H. An in vitro comparison of the effects of various air polishing powders on enamel and selected esthetic restorative materials. J Clin Dent. 2014;25(4):76-87.
PubMed 26054183Pelka M, Trautmann S, Petschelt A, Lohbauer U. Influence of air-polishing devices and abrasives on root dentin-an in vitro confocal laser scanning microscope study. Quintessence Int. 2010 Jul-Aug;41(7):e141-8.
PubMed 20614037Sahrmann P, Ronay V, Schmidlin PR, Attin T, Paque F. Three-dimensional defect evaluation of air polishing on extracted human roots. J Periodontol. 2014 Aug;85(8):1107-14. doi: 10.1902/jop.2014.130629. Epub 2014 Jan 30.
PubMed 24476548Tada K, Kakuta K, Ogura H, Sato S. Effect of particle diameter on air polishing of dentin surfaces. Odontology. 2010 Feb;98(1):31-6. doi: 10.1007/s10266-009-0113-8. Epub 2010 Feb 16.
PubMed 20155505Tada K, Wiroj S, Inatomi M, Sato S. The characterization of dentin defects produced by air polishing. Odontology. 2012 Jan;100(1):41-6. doi: 10.1007/s10266-011-0019-0. Epub 2011 May 10.
PubMed 21556726Herr ML, DeLong R, Li Y, Lunos SA, Stoltenberg JL. Use of a continual sweep motion to compare air polishing devices, powders and exposure time on unexposed root cementum. Odontology. 2017 Jul;105(3):311-319. doi: 10.1007/s10266-016-0282-1. Epub 2017 Jan 9.
PubMed 28070701Camboni S, Donnet M. Tooth Surface Comparison after Air Polishing and Rubber Cup: A Scanning Electron Microscopy Study. J Clin Dent. 2016 Mar;27(1):13-18.
PubMed 28390211
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Effect of Different Polishing Materials on Different Dental Tissues by Micro-Computed Tomography
- ClinicalTrials.gov ID
- NCT04853745
- Acronym / sponsor ID
- KOU GOKAEK 2019/10.34
- Conditions
- Dental Plaque
- Keywords
- glycine, erythritol, sodium bicarbonate, x-ray microtomography, gingival recession, air abrasion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 21 Apr 2021 (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.
The use of air-polishing device that operates by directing a fine slurry of pressurized air, water, and abrasive particles has become widespread in dentistry for polishing. The introduction of abrasive powders with different properties creates the need to evaluate the effects of these powders on dental hard tissues. This study was focused on the effect of sodium bicarbonate, glycine and erythritol air polishing on enamel and exposed root surface.
Detailed description
The aim of this study is to evaluate the effect of sodium bicarbonate, glycine and erythritol air polishing on enamel and exposed root surface. Forty eight single root extracted teeth were included into the study. The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect depth, defect volume, demineralization depth and mineral density values were estimated.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate group | – | Device: AIR-FLOW® Master PiezonSodium bicarbonate-based powder (CLASSIC®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application. |
| glycine group | – | Device: AIR-FLOW® Master PiezonGlycine-based powder (PERIO®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application. |
| erythritol group | – | Device: AIR-FLOW® Master PiezonErythritol-based powder (PLUS®, EMS SA, Nyon, Switzerland) was used for air polishing the samples belonging to this group. All surfaces were numbered and application was made to the mesial and distal surfaces of the root, buccal and lingual surfaces of the crown to avoid repeated instrumentations. After device and samples were fixed, a metal plate with a 5 mm diameter hole was placed on the sample to limit the application area. Surfaces one and three were air-polished using the with a medium power setting (9 LED power setting), and surfaces two and four were air-polished using the with a maximum power setting (17 LED power setting). The distance between the handpiece and the tooth surface was kept constant at 5 mm, and the treatment angulation was adjusted to 60 degrees. In all applications, the application time was 5 seconds and the water setting was medium (6 LED). The powder chambers of the device were filled to the maximum level in each application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry.
Key inclusion criteria (4 listed)
- Being older than age of 18,
- Willing to participate the study,
- To have a single rooted tooth with gingival recession on all surfaces and need to be extracted,
- The tooth has to be free of caries, defects and restorations.
Key exclusion criteria (1 listed)
- Have history of infectious diseases like Hepatitis and/or HIV (+).
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 |
|---|---|---|
| AIR-FLOW® Master PiezonAIR-FLOW® Master Piezon is intended for use in the cleaning and polishing of teeth by the projection of water,air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. This air polishing device was used for all powder instrumentations. | Device | erythritol group, glycine group, sodium bicarbonate group |
Primary outcome
Defect depth
Time frame: 5 second
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect depth was estimated.
Demineralization depth
Time frame: 5 second
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the demineralization depth was estimated.
Mineral density
Time frame: 10 second
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5 mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the mineral density was estimated.
Defect volume
Time frame: 5 second
The teeth were divided into three groups, the crown and exposed root surface were air polished using three powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree. Samples were scanned in a micro-computed tomography (micro-CT) at baseline and then after powder treatment and the defect volume was estimated.
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 21 Apr 2021.
- Background: PubMed 21134232Petersilka GJ. Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontol 2000. 2011 Feb;55(1):124-42. doi: 10.1111/j.1600-0757.2010.00342.x. No abstract available.
- Background: PubMed 23986410Graumann SJ, Sensat ML, Stoltenberg JL. Air polishing: a review of current literature. J Dent Hyg. 2013 Aug;87(4):173-80.
- Background: PubMed 9693568Gutmann ME. Air polishing: a comprehensive review of the literature. J Dent Hyg. 1998 Summer;72(3):47-56.
- Background: PubMed 6592321Weaks LM, Lescher NB, Barnes CM, Holroyd SV. Clinical evaluation of the Prophy-Jet as an instrument for routine removal of tooth stain and plaque. J Periodontol. 1984 Aug;55(8):486-8. doi: 10.1902/jop.1984.55.8.486.
- Background: PubMed 3295185Berkstein S, Reiff RL, McKinney JF, Killoy WJ. Supragingival root surface removal during maintenance procedures utilizing an air-powder abrasive system or hand scaling. An in vitro study. J Periodontol. 1987 May;58(5):327-30. doi: 10.1902/jop.1987.58.5.327.
- Background: PubMed 2136972Barnes CM, Russell CM, Gerbo LR, Wells BR, Barnes DW. Effects of an air-powder polishing system on orthodontically bracketed and banded teeth. Am J Orthod Dentofacial Orthop. 1990 Jan;97(1):74-81. doi: 10.1016/S0889-5406(05)81712-3. No abstract available.
- Background: PubMed 2366141Kontturi-Narhi V, Markkanen S, Markkanen H. Effects of airpolishing on dental plaque removal and hard tissues as evaluated by scanning electron microscopy. J Periodontol. 1990 Jun;61(6):334-8. doi: 10.1902/jop.1990.61.6.334.
- Background: PubMed 6319658Atkinson DR, Cobb CM, Killoy WJ. The effect of an air-powder abrasive system on in vitro root surfaces. J Periodontol. 1984 Jan;55(1):13-8. doi: 10.1902/jop.1984.55.1.13.
- Background: PubMed 26054183Barnes CM, Covey D, Watanabe H, Simetich B, Schulte JR, Chen H. An in vitro comparison of the effects of various air polishing powders on enamel and selected esthetic restorative materials. J Clin Dent. 2014;25(4):76-87.
- Background: PubMed 20614037Pelka M, Trautmann S, Petschelt A, Lohbauer U. Influence of air-polishing devices and abrasives on root dentin-an in vitro confocal laser scanning microscope study. Quintessence Int. 2010 Jul-Aug;41(7):e141-8.
- Background: PubMed 24476548Sahrmann P, Ronay V, Schmidlin PR, Attin T, Paque F. Three-dimensional defect evaluation of air polishing on extracted human roots. J Periodontol. 2014 Aug;85(8):1107-14. doi: 10.1902/jop.2014.130629. Epub 2014 Jan 30.
- Background: PubMed 20155505Tada K, Kakuta K, Ogura H, Sato S. Effect of particle diameter on air polishing of dentin surfaces. Odontology. 2010 Feb;98(1):31-6. doi: 10.1007/s10266-009-0113-8. Epub 2010 Feb 16.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Plaque, run by Kocaeli University 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 4 inclusion and 1 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 21 Apr 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?
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?
Defect depth (time frame: 5 second). The study lists 4 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 NCT04853745, which also lists 19 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 21 Apr 2021.