Malocclusion, Angle Class II, Division 1NCT03999307
Low-Level Laser Therapy and Flapless Corticopuncture Effect on Accelerating Six Maxillary Anterior Teeth Retraction
A study testing Low-Level Laser Therapy (LLLT) and Flapless Corticopunture in people with Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.
Trial summary
The long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Malocclusion, Angle Class II, Division 1
- What is being tested?
- Low-Level Laser Therapy (LLLT) and Flapless Corticopunture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSyria
- Study dates
- 6 Aug 2018to 6 Nov 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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient age between (18 - 24) years.
- Class II Division 1 malocclusion that indicates extraction of two maxillary first premolars with the following parameters:
- ANB: 5 to 10 degrees. Overjet: 5 to 10 mm. Growth Pattern: normal or slightly vertical.
- All upper teeth are existed (Except for third molars).
- Mild to moderate crowding (3 mm or less).
- Patient dose not undergo any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …).
- Good oral hygiene (Plaque index < 1).
Who cannot join
- Any medical condition affecting orthodontic tooth movement.
- Poor oral hygiene (Plaque index > 1).
- Patient did not undergo previous orthodontic treatment.
- Patient lack of commitment toward follow-up appointments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Low-Level Laser Therapy (LLLT) and Flapless Corticopuncture Effect on Accelerating Implant-Supported En-Masse Retraction of the Six Maxillary Anterior Teeth (Clinical Randomized Controlled Trial)
The long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. Therefore, the purpose of this study is to evaluate the efficiency of two new noninvasive methods (Low-Level Laser Therapy and Corticopuncture) in accelerating orthodontic tooth movement for the implant supported En-Masse retraction of the six maxillary anterior teeth.
Read the detailed description
This study will be a randomized controlled trial with a 1:1:1 allocation ratio. Sample size was calculated using Minitab version 15. 36 Participants recruited from patients attending the Department of Orthodontics and Dentofacial Orthopedics at Damascus University with class II division 1 malocclusion that indicates the extraction of first maxillary premolars will be randomly assigned into one of three groups: Low-Level Laser Therapy (LLLT) group, flapless corticopuncture group, or control group. Titanium mini-implants (1.6 mm diameter and 7 mm length) will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm height above the archwires below the mucogingival junction. After complete leveling and alignment of the maxillary dental arch, which will be defined by passive insertion of 19*25 inch S.S. archwire, the retraction stage of the six maxillary anterior teeth will begin.
- Conditions
- Malocclusion, Angle Class II, Division 1
- Being tested
- Low-Level Laser Therapy (LLLT), Flapless Corticopunture, Control
- Keywords
- Orthodontic Tooth Movement Acceleration
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Therapy (LLLT)Radiation
LLLT will be applied in this group
Flapless CorticopuntureProcedure or surgery
Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur
ControlOther
Typical orthodontic treatment with no LLLT or flapless corticopuncture
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Laser Therapy (LLLT) | Experimental | In the LLLT group, a low-level laser with wavelength of 808 nm, output of 250 mW, energy of 4 Joules per point and application time of 16 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol: the root will be divided theoretically into 2 halves; gingival and cervical, and laser will be applied in the center of each half from both buccal and palatal sides which means 4 application points and a total energy of 16 Joules per tooth. Receives: Radiation: Low-Level Laser Therapy (LLLT) |
| Flapless Corticopuncture | Experimental | In the flapless corticopuncture group, 3 interdental punctures located between the roots of the six maxillary anterior teeth from both the buccal and palatal sides, will be done using a 1-mm diameter round surgical Tungsten bur with 1 mm depth and 1.5 mm space between each puncture. These punctures start 2 mm from the free gingiva. Besides, an additional 2 parallel set of punctures with the same dimensions of the interdental ones will be done in the extraction sockets from both the buccal and palatal sides. Receives: Procedure: Flapless Corticopunture |
| Control | Experimental | Patients in control group will undergo typical orthodontic treatment only with no LLLT or flapless corticopuncture application. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of en-masse retraction of the six maxillary anterior teeth
Assessment will be performed by calculating the time required from the beginning of the six maxillary anterior teeth retraction till the completion of this procedure
Measured: The months required to complete the retraction procedure will be recorded, which is expected to be occur within four months
Rate of en-masse retraction of the six maxillary anterior teeth
Assessment will be performed on study models by dividing the distance that the six maxillary anterior teeth moved during retraction to the time required to retract them to their ideal positions.
Measured: The calculation of the rate of retraction will be done once the retraction procedure has finished which is expected to occur within four months
Secondary outcomes (6)
Maxillary first molar anchorage loss
Assessment will be performed on study casts by calculating the amount of mesial drifting of the maxillary molar (if any) in millimeters before and after retraction
Measured: This outcome will be measured one day before upper incisors' retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Root resorption
Assessment will be performed by subtracting the root length of each maxillary anterior tooth after retraction from its length before starting retraction procedure.
Measured: A CBCT image will be taken one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Changes in the gingival indices
Assessment will be performed clinically using the WHO probe
Measured: This outcome will be measured one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Change in tooth vitality (the response of the pulp tissue toward external stimuli)
Tooth vitality will be evaluated for each tooth of the six maxillary anterior teeth using Ethyl Chloride applied by a cotton roll on each tooth, which will indicate negative response (no vitality) or positive response (vital pulp)
Measured: This outcome will be measured one day before the six maxillary anterior teeth retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Changes in the levels of pain and discomfort
Assessment will be performed using questionnaires that include Visual Analog Scale (VAS) for each question, the scale has a minimum scale of 0 (no pain or discomfort) and a maximum scale of 100 (maximum pain or discomfort).
Measured: These levels will be assessed at: one day, one week, two weeks, and four weeks following the intervention
Change in the Oral Health Related Quality of Life associated with anterior teeth retraction.
Assessment will be performed using the OHIP-14 questionnaire; which is a questionnaire that include 14 questions regarding different aspects of problems that might be associated with retraction (discomfort, stress, chewing difficulties, ...). the patient could choose the answer from a five-point Likert scale (Never, Hardly ever, Occasionally, Fairly often, Very often)
Measured: The OHIP-14 will be assessed immediately after application, after 1, 7, 14, and 28 days of the six maxillary anterior teeth retraction initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start6 Aug 2018
- Primary completion6 Jun 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class II, Division 1Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Moaffak A. AlSayed Hasan, DDS, Msc Ortho, PhD Student, Principal investigator, PhD Student, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab RepublicMowaffak Ajaj, DDS, Msc Ortho, PhD, Study chair, Assistant Professor, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab RepublicOmar Hamadah, DDS, Msc, PhD, Study chair, Assistant Professor, Department of Oral Medicine - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999307
- Sponsor's protocol ID
- UDDS-Ortho-04-2020
- Status last verified
- Jan 2021
- First submitted
- 10 Jun 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.
PubMed 27869476Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
PubMed 23787192Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
PubMed 22381489Hoogeveen EJ, Jansma J, Ren Y. Surgically facilitated orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S51-64. doi: 10.1016/j.ajodo.2013.11.019.
PubMed 24680025Tuncer NI, Arman-Ozcirpici A, Oduncuoglu BF, Gocmen JS, Kantarci A. Efficiency of piezosurgery technique in miniscrew supported en-masse retraction: a single-centre, randomized controlled trial. Eur J Orthod. 2017 Nov 30;39(6):586-594. doi: 10.1093/ejo/cjx015.
PubMed 28402521Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
PubMed 27696311Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
PubMed 24182579
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Level Laser Therapy (LLLT) and Flapless Corticopuncture Effect on Accelerating Implant-Supported En-Masse Retraction of the Six Maxillary Anterior Teeth (Clinical Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT03999307
- Acronym / sponsor ID
- UDDS-Ortho-04-2020
- Conditions
- Malocclusion, Angle Class II, Division 1
- Keywords
- Orthodontic Tooth Movement Acceleration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 26 Jun 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.
The long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. Therefore, the purpose of this study is to evaluate the efficiency of two new noninvasive methods (Low-Level Laser Therapy and Corticopuncture) in accelerating orthodontic tooth movement for the implant supported En-Masse retraction of the six maxillary anterior teeth.
Detailed description
This study will be a randomized controlled trial with a 1:1:1 allocation ratio. Sample size was calculated using Minitab version 15. 36 Participants recruited from patients attending the Department of Orthodontics and Dentofacial Orthopedics at Damascus University with class II division 1 malocclusion that indicates the extraction of first maxillary premolars will be randomly assigned into one of three groups: Low-Level Laser Therapy (LLLT) group, flapless corticopuncture group, or control group. Titanium mini-implants (1.6 mm diameter and 7 mm length) will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm height above the archwires below the mucogingival junction. After complete leveling and alignment of the maxillary dental arch, which will be defined by passive insertion of 19*25 inch S.S. archwire, the retraction stage of the six maxillary anterior teeth will begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy (LLLT) | Experimental | Radiation: Low-Level Laser Therapy (LLLT)In the LLLT group, a low-level laser with wavelength of 808 nm, output of 250 mW, energy of 4 Joules per point and application time of 16 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol: the root will be divided theoretically into 2 halves; gingival and cervical, and laser will be applied in the center of each half from both buccal and palatal sides which means 4 application points and a total energy of 16 Joules per tooth. |
| Flapless Corticopuncture | Experimental | Procedure: Flapless CorticopuntureIn the flapless corticopuncture group, 3 interdental punctures located between the roots of the six maxillary anterior teeth from both the buccal and palatal sides, will be done using a 1-mm diameter round surgical Tungsten bur with 1 mm depth and 1.5 mm space between each puncture. These punctures start 2 mm from the free gingiva. Besides, an additional 2 parallel set of punctures with the same dimensions of the interdental ones will be done in the extraction sockets from both the buccal and palatal sides. |
| Control | Experimental | Other: ControlPatients in control group will undergo typical orthodontic treatment only with no LLLT or flapless corticopuncture application. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient age between (18 - 24) years.
- Class II Division 1 malocclusion that indicates extraction of two maxillary first premolars with the following parameters:
- ANB: 5 to 10 degrees. Overjet: 5 to 10 mm. Growth Pattern: normal or slightly vertical.
- All upper teeth are existed (Except for third molars).
- Mild to moderate crowding (3 mm or less).
Key exclusion criteria (4 listed)
- Any medical condition affecting orthodontic tooth movement.
- Poor oral hygiene (Plaque index > 1).
- Patient did not undergo previous orthodontic treatment.
- Patient lack of commitment toward follow-up appointments.
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 |
|---|---|---|
| Low-Level Laser Therapy (LLLT)LLLT will be applied in this group | Radiation | Low-Level Laser Therapy (LLLT) |
| Flapless CorticopuntureSmall holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur | Procedure or surgery | Flapless Corticopuncture |
| ControlTypical orthodontic treatment with no LLLT or flapless corticopuncture | Other | Control |
Primary outcome
Duration of en-masse retraction of the six maxillary anterior teeth
Time frame: The months required to complete the retraction procedure will be recorded, which is expected to be occur within four months
Assessment will be performed by calculating the time required from the beginning of the six maxillary anterior teeth retraction till the completion of this procedure
Rate of en-masse retraction of the six maxillary anterior teeth
Time frame: The calculation of the rate of retraction will be done once the retraction procedure has finished which is expected to occur within four months
Assessment will be performed on study models by dividing the distance that the six maxillary anterior teeth moved during retraction to the time required to retract them to their ideal positions.
6 secondary outcomes
Maxillary first molar anchorage loss
Time frame: This outcome will be measured one day before upper incisors' retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Root resorption
Time frame: A CBCT image will be taken one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Changes in the gingival indices
Time frame: This outcome will be measured one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Change in tooth vitality (the response of the pulp tissue toward external stimuli)
Time frame: This outcome will be measured one day before the six maxillary anterior teeth retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months
Changes in the levels of pain and discomfort
Time frame: These levels will be assessed at: one day, one week, two weeks, and four weeks following the intervention
Change in the Oral Health Related Quality of Life associated with anterior teeth retraction.
Time frame: The OHIP-14 will be assessed immediately after application, after 1, 7, 14, and 28 days of the six maxillary anterior teeth retraction initiation
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 20 Jan 2021.
- Background: PubMed 27869476AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.
- Background: PubMed 23787192Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
- Background: PubMed 22381489Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
- Background: PubMed 24680025Hoogeveen EJ, Jansma J, Ren Y. Surgically facilitated orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S51-64. doi: 10.1016/j.ajodo.2013.11.019.
- Background: PubMed 28402521Tuncer NI, Arman-Ozcirpici A, Oduncuoglu BF, Gocmen JS, Kantarci A. Efficiency of piezosurgery technique in miniscrew supported en-masse retraction: a single-centre, randomized controlled trial. Eur J Orthod. 2017 Nov 30;39(6):586-594. doi: 10.1093/ejo/cjx015.
- Results publication: PubMed 27696311Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
- Results publication: PubMed 24182579Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
- 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.
Mohammad Moaffak A. AlSayed Hasan, DDS, Msc Ortho, PhD Student principal investigator
PhD Student, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
Mowaffak Ajaj, DDS, Msc Ortho, PhD study chair
Assistant Professor, Department of Orthodontics and Dentofacial Orthopedics - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
Omar Hamadah, DDS, Msc, PhD study chair
Assistant Professor, Department of Oral Medicine - Faculty of Dental Medicine - Damascus University - Damascus - Syrian Arab Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy (LLLT) and Flapless Corticopunture in people with Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.
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 7 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: finished, as of the sponsor's last update on 20 Jan 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 Syria. 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?
Duration of en-masse retraction of the six maxillary anterior teeth (time frame: The months required to complete the retraction procedure will be recorded, which is expected to be occur within four 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 NCT03999307, which also lists 7 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 20 Jan 2021.