Tooth DiscolorationPhase 4NCT04407910
Office Bleaching Treatment by Using Rubber-cup and Air-powder Polishing Device Prophylaxis in Rondomised Clinical Design
A Phase 4 study testing AIRFLOW® Master device +Opalescence Xtra Boost. and rubber-cup+Opalescence Xtra Boost. in people with Tooth Discoloration and Color Changes During Tooth Formation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The increasing demand for whitening teeth necessitates requirements and guidelines to ensure the efficacy of products and bleaching techniques. So far there is no comparative study to evaluate the effectiveness of pre-operative air-powder polishing device (APD) and rubber-cup prophylaxis on tooth bleaching in-office. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Color Changes During Tooth Formation
- What is being tested?
- AIRFLOW® Master device +Opalescence Xtra Boost. and rubber-cup+Opalescence Xtra Boost.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2018to 17 May 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - being at least 18 years of age
- having minimum of 20 natural teeth (including incisors, canines, and premolars in both arches)
- having good oral hygiene (Plaque index <1, Gingival index <1)
Who cannot join
- having restorations or active caries on the anterior teeth of either arch
- presence of tetracycline staining or fluorosis
- general hypersensitivity
- gingival recession or periodontal disease
- smokers
- pregnant or lactating women
- history of prior bleaching treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-operative Air-powder Polishing and Rubber-cup Prophylaxis on Tooth Bleaching Outcomes: Randomised Controlled Split-mouth Clinical Study
The increasing demand for whitening teeth necessitates requirements and guidelines to ensure the efficacy of products and bleaching techniques. So far there is no comparative study to evaluate the effectiveness of pre-operative air-powder polishing device (APD) and rubber-cup prophylaxis on tooth bleaching in-office. Office-bleaching has some advantages such as avoiding soft tissue irritation, preventing the use of excess material and producing immediate esthetic results.
The aim this study is to compare the effects of pre-operative air-powder polishing and rubber-cup prophylaxis on tooth bleaching outcomes. The null hypothesis of this research was that there would be no difference in the change in according to the type of prophylaxis on tooth-bleaching outcomes.△L,△a,△b,△E and △SGU.
The results of the study show that both rubber cup prophylaxis and APD devices can be equally used before bleaching treatment as there were no statistical differences in color change.
Read the detailed description
Tooth color was measured using spectrophotometer VITA Easyshade V (Vita Zahnfabrik, Germany). The spectrophotometer was calibrated before use in each participant and the device tip was placed on middle thirds of the labial surface of teeth as suggested by the manufacturer's manual.
The tooth color was measured before initial prophylaxis (baseline), immediately after bleaching and after one week. The digital spectrophotometer used in the current study measures the shade of teeth based on the CIE (Commission Internationale de l'éclairage) L*a*b* color space system. This system expresses color as three values: L* for the lightness from black (0) to white (100), a* from green (-) to red (+), and b* from blue (-) to yellow (+). The following values were recorded in the units of CIE L*a*b* color space.
-Data of lightness (L*) and a* and b*axis
-△e: a teeth color change (△e*) was derived as: △e = [(△L *)2+ (△a *)2 + (△b *)2]1/2 While making Shade guide units (SGU) measurements, the bleached index is set according to the VITA Bleached guide 3D-MASTER at spectrophotometer for the measured shade. The measured bleached index after treatment was subtracted from the baseline value. The difference corresponded to the change of the SGU (△ SGU) achieved immediately and 1 week after the bleaching treatment.
The patients had bleaching treatment on the maxillary anterior area including right and left canines. The right and left sides of the patients were randomized by toss of a coin to receive polishing with rubber cup prophylaxis or air powder polishing system before bleaching.
All prophylaxis procedures were performed by same clinician (M.O.). The rubber cup prophylaxis was applied with low-speed handpieces. A rubber cup was attached to the prophy-angle. The handpiece used at a steady slow pace of 2500-3000 rpm. The rubber cup contacted each tooth surface for an average of 5 seconds together with polishing paste consisting of flour of pumice, glycerin and fluoride.
The air polishing treatment was performed by AIRFLOW® Master device (EMS, Nyon, Switzerland) with a six LED (Light Emitting Diode) power setting (2.2 bars dynamic pressure inside powder chamber) and an 11 LED (35 mL/min) water setting for 30 seconds (powder consumption was 1.1 g). Sodium bicarbonate air-powder polishing powder (AIR-FLOW® Plus, EMS Electro Medical Systems, Nyon, Switzerland) was used. The nozzle was held 3-4 mm from the tooth surface and the tip was angulated diagonally. The spray was delivered for an average of 5 seconds using a constant circular motion for each tooth. The spray was directed towards the middle one-thirds of the exposed tooth.
All bleaching procedures were performed by same clinician (Z.G.B.K.). The bleaching agent (Opalescence Xtra Boost/ Ultradent, South Jordan, Utah, USA) was prepared and used following the manufacturer's instructions. Opal Dam (Ultradent, South Jordan, Utah, USA) was used for protection of the gingiva. The bleaching gel was then applied to form 1-2 mm thickness on the buccal surfaces of the teeth of both arches. The gel remained on teeth for 15 minutes and was then suctioned from teeth using a surgical suction tip. This application was repeated a second time in the same session.
- Being tested
- AIRFLOW® Master device +Opalescence Xtra Boost., rubber-cup+Opalescence Xtra Boost.
- Keywords
- Tooth Bleaching, Prophylaxis, Dental Materials
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRFLOW® Master device +Opalescence Xtra Boost.Combination product
Prophylaxis techniques for pre-bleaching treatment
rubber-cup+Opalescence Xtra Boost.Combination product
Prophylaxis techniques for pre-bleaching treatment
| Study group | Role | What they receive |
|---|---|---|
| Air-powder polishing device | Experimental | Not described Receives: Combination Product: AIRFLOW® Master device +Opalescence Xtra Boost.; Combination Product: rubber-cup+Opalescence Xtra Boost. |
| Rubber-cup+paste | Experimental | Not described Receives: Combination Product: AIRFLOW® Master device +Opalescence Xtra Boost.; Combination Product: rubber-cup+Opalescence Xtra Boost. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔE
Delta E is a metric for understanding how the human eye perceives color difference
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start10 Sep 2018
- Primary completion18 Mar 2019
- Study completion17 May 2019
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 Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by Cukurova 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We have two groups applied to split-mouth experimental units. Left side of maxillary have received rubber-cup and right side of maxillary of each subject.have APD prophylaxis respectively.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zeliha gonca bek kurklu, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407910
- Sponsor's protocol ID
- 1-6-18-78/78
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sulieman M. An overview of tooth discoloration: extrinsic, intrinsic and internalized stains. Dent Update. 2005 Oct;32(8):463-4, 466-8, 471. doi: 10.12968/denu.2005.32.8.463.
PubMed 16262034Watts A, Addy M. Tooth discolouration and staining: a review of the literature. Br Dent J. 2001 Mar 24;190(6):309-16. doi: 10.1038/sj.bdj.4800959.
PubMed 11325156Kihn PW. Vital tooth whitening. Dent Clin North Am. 2007 Apr;51(2):319-31, viii. doi: 10.1016/j.cden.2006.12.001.
PubMed 17532915Gallagher A, Maggio B, Bowman J, Borden L, Mason S, Felix H. Clinical study to compare two in-office (chairside) whitening systems. J Clin Dent. 2002;13(6):219-24.
PubMed 12518494Joiner A. The bleaching of teeth: a review of the literature. J Dent. 2006 Aug;34(7):412-9. doi: 10.1016/j.jdent.2006.02.002. Epub 2006 Mar 29.
PubMed 16569473Seghi RR, Denry I. Effects of external bleaching on indentation and abrasion characteristics of human enamel in vitro. J Dent Res. 1992 Jun;71(6):1340-4. doi: 10.1177/00220345920710061201.
PubMed 1613185Patil SS, Rakhewar PS, Limaye PS, Chaudhari NP. A comparative evaluation of plaque-removing efficacy of air polishing and rubber-cup, bristle brush with paste polishing on oral hygiene status: A clinical study. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):457-62. doi: 10.4103/2231-0762.167723.
PubMed 26759798Bernardon JK, Ferrari P, Baratieri LN, Rauber GB. Comparison of treatment time versus patient satisfaction in at-home and in-office tooth bleaching therapy. J Prosthet Dent. 2015 Dec;114(6):826-30. doi: 10.1016/j.prosdent.2015.05.014. Epub 2015 Sep 12.
PubMed 26372629Sawai MA, Bhardwaj A, Jafri Z, Sultan N, Daing A. Tooth polishing: The current status. J Indian Soc Periodontol. 2015 Jul-Aug;19(4):375-80. doi: 10.4103/0972-124X.154170.
PubMed 26392683Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
PubMed 20166405Chowdhary Z, Mohan R. Efficiency of three different polishing methods on enamel and cementum: A scanning electron microscope study. J Indian Soc Periodontol. 2018 Jan-Feb;22(1):18-24. doi: 10.4103/jisp.jisp_40_17.
PubMed 29568167Wiegand A, Drebenstedt S, Roos M, Magalhaes AC, Attin T. 12-month color stability of enamel, dentine, and enamel-dentine samples after bleaching. Clin Oral Investig. 2008 Dec;12(4):303-10. doi: 10.1007/s00784-008-0195-7. Epub 2008 Mar 28.
PubMed 18369668Giachetti L, Bertini F, Bambi C, Nieri M, Scaminaci Russo D. A randomized clinical trial comparing at-home and in-office tooth whitening techniques: A nine-month follow-up. J Am Dent Assoc. 2010 Nov;141(11):1357-64. doi: 10.14219/jada.archive.2010.0081.
PubMed 21037194Barry TN, Bailey CW, Ashcraft-Olmscheid D, Vandewalle KS. Effect of a New Bleaching Gel on Tooth Whitening. Oper Dent. 2017 Sep/Oct;42(5):559-566. doi: 10.2341/16-200-L.
PubMed 28829933Nakamura T, Saito O, Ko T, Maruyama T. The effects of polishing and bleaching on the colour of discoloured teeth in vivo. J Oral Rehabil. 2001 Nov;28(11):1080-4. doi: 10.1046/j.1365-2842.2001.00762.x.
PubMed 11722726
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-operative Air-powder Polishing and Rubber-cup Prophylaxis on Tooth Bleaching Outcomes: Randomised Controlled Split-mouth Clinical Study
- ClinicalTrials.gov ID
- NCT04407910
- Acronym / sponsor ID
- 1-6-18-78/78
- Keywords
- Tooth Bleaching, Prophylaxis, Dental Materials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 29 May 2020 (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 increasing demand for whitening teeth necessitates requirements and guidelines to ensure the efficacy of products and bleaching techniques. So far there is no comparative study to evaluate the effectiveness of pre-operative air-powder polishing device (APD) and rubber-cup prophylaxis on tooth bleaching in-office. Office-bleaching has some advantages such as avoiding soft tissue irritation, preventing the use of excess material and producing immediate esthetic results.
The aim this study is to compare the effects of pre-operative air-powder polishing and rubber-cup prophylaxis on tooth bleaching outcomes. The null hypothesis of this research was that there would be no difference in the change in according to the type of prophylaxis on tooth-bleaching outcomes.△L,△a,△b,△E and △SGU.
The results of the study show that both rubber cup prophylaxis and APD devices can be equally used before bleaching treatment as there were no statistical differences in color change.
Detailed description
Tooth color was measured using spectrophotometer VITA Easyshade V (Vita Zahnfabrik, Germany). The spectrophotometer was calibrated before use in each participant and the device tip was placed on middle thirds of the labial surface of teeth as suggested by the manufacturer's manual.
The tooth color was measured before initial prophylaxis (baseline), immediately after bleaching and after one week. The digital spectrophotometer used in the current study measures the shade of teeth based on the CIE (Commission Internationale de l'éclairage) L*a*b* color space system. This system expresses color as three values: L* for the lightness from black (0) to white (100), a* from green (-) to red (+), and b* from blue (-) to yellow (+). The following values were recorded in the units of CIE L*a*b* color space.
-Data of lightness (L*) and a* and b*axis
-△e: a teeth color change (△e*) was derived as: △e = [(△L *)2+ (△a *)2 + (△b *)2]1/2 While making Shade guide units (SGU) measurements, the bleached index is set according to the VITA Bleached guide 3D-MASTER at spectrophotometer for the measured shade. The measured bleached index after treatment was subtracted from the baseline value. The difference corresponded to the change of the SGU (△ SGU) achieved immediately and 1 week after the bleaching treatment.
The patients had bleaching treatment on the maxillary anterior area including right and left canines. The right and left sides of the patients were randomized by toss of a coin to receive polishing with rubber cup prophylaxis or air powder polishing system before bleaching.
All prophylaxis procedures were performed by same clinician (M.O.). The rubber cup prophylaxis was applied with low-speed handpieces. A rubber cup was attached to the prophy-angle. The handpiece used at a steady slow pace of 2500-3000 rpm. The rubber cup contacted each tooth surface for an average of 5 seconds together with polishing paste consisting of flour of pumice, glycerin and fluoride.
The air polishing treatment was performed by AIRFLOW® Master device (EMS, Nyon, Switzerland) with a six LED (Light Emitting Diode) power setting (2.2 bars dynamic pressure inside powder chamber) and an 11 LED (35 mL/min) water setting for 30 seconds (powder consumption was 1.1 g). Sodium bicarbonate air-powder polishing powder (AIR-FLOW® Plus, EMS Electro Medical Systems, Nyon, Switzerland) was used. The nozzle was held 3-4 mm from the tooth surface and the tip was angulated diagonally. The spray was delivered for an average of 5 seconds using a constant circular motion for each tooth. The spray was directed towards the middle one-thirds of the exposed tooth.
All bleaching procedures were performed by same clinician (Z.G.B.K.). The bleaching agent (Opalescence Xtra Boost/ Ultradent, South Jordan, Utah, USA) was prepared and used following the manufacturer's instructions. Opal Dam (Ultradent, South Jordan, Utah, USA) was used for protection of the gingiva. The bleaching gel was then applied to form 1-2 mm thickness on the buccal surfaces of the teeth of both arches. The gel remained on teeth for 15 minutes and was then suctioned from teeth using a surgical suction tip. This application was repeated a second time in the same session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We have two groups applied to split-mouth experimental units. Left side of maxillary have received rubber-cup and right side of maxillary of each subject.have APD prophylaxis respectively.
| Arm | Type | Receives |
|---|---|---|
| Air-powder polishing device | Experimental | Combination Product: AIRFLOW® Master device +Opalescence Xtra Boost., Combination Product: rubber-cup+Opalescence Xtra Boost. |
| Rubber-cup+paste | Experimental | Combination Product: AIRFLOW® Master device +Opalescence Xtra Boost., Combination Product: rubber-cup+Opalescence Xtra Boost. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - being at least 18 years of age
- having minimum of 20 natural teeth (including incisors, canines, and premolars in both arches)
- having good oral hygiene (Plaque index <1, Gingival index <1)
Key exclusion criteria (7 listed)
- having restorations or active caries on the anterior teeth of either arch
- presence of tetracycline staining or fluorosis
- general hypersensitivity
- gingival recession or periodontal disease
- smokers
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 |
|---|---|---|
| AIRFLOW® Master device +Opalescence Xtra Boost.Prophylaxis techniques for pre-bleaching treatment | Combination product | Air-powder polishing device, Rubber-cup+paste |
| rubber-cup+Opalescence Xtra Boost.Prophylaxis techniques for pre-bleaching treatment | Combination product | Air-powder polishing device, Rubber-cup+paste |
Primary outcome
ΔE
Time frame: 1 week
Delta E is a metric for understanding how the human eye perceives color difference
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 29 May 2020.
- Background: PubMed 16262034Sulieman M. An overview of tooth discoloration: extrinsic, intrinsic and internalized stains. Dent Update. 2005 Oct;32(8):463-4, 466-8, 471. doi: 10.12968/denu.2005.32.8.463.
- Background: PubMed 11325156Watts A, Addy M. Tooth discolouration and staining: a review of the literature. Br Dent J. 2001 Mar 24;190(6):309-16. doi: 10.1038/sj.bdj.4800959.
- Background: PubMed 17532915Kihn PW. Vital tooth whitening. Dent Clin North Am. 2007 Apr;51(2):319-31, viii. doi: 10.1016/j.cden.2006.12.001.
- Background: PubMed 12518494Gallagher A, Maggio B, Bowman J, Borden L, Mason S, Felix H. Clinical study to compare two in-office (chairside) whitening systems. J Clin Dent. 2002;13(6):219-24.
- Background: PubMed 16569473Joiner A. The bleaching of teeth: a review of the literature. J Dent. 2006 Aug;34(7):412-9. doi: 10.1016/j.jdent.2006.02.002. Epub 2006 Mar 29.
- Background: PubMed 1613185Seghi RR, Denry I. Effects of external bleaching on indentation and abrasion characteristics of human enamel in vitro. J Dent Res. 1992 Jun;71(6):1340-4. doi: 10.1177/00220345920710061201.
- Background: PubMed 26759798Patil SS, Rakhewar PS, Limaye PS, Chaudhari NP. A comparative evaluation of plaque-removing efficacy of air polishing and rubber-cup, bristle brush with paste polishing on oral hygiene status: A clinical study. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):457-62. doi: 10.4103/2231-0762.167723.
- Background: PubMed 26372629Bernardon JK, Ferrari P, Baratieri LN, Rauber GB. Comparison of treatment time versus patient satisfaction in at-home and in-office tooth bleaching therapy. J Prosthet Dent. 2015 Dec;114(6):826-30. doi: 10.1016/j.prosdent.2015.05.014. Epub 2015 Sep 12.
- Background: PubMed 26392683Sawai MA, Bhardwaj A, Jafri Z, Sultan N, Daing A. Tooth polishing: The current status. J Indian Soc Periodontol. 2015 Jul-Aug;19(4):375-80. doi: 10.4103/0972-124X.154170.
- Background: PubMed 20166405Bernardon JK, Sartori N, Ballarin A, Perdigao J, Lopes GC, Baratieri LN. Clinical performance of vital bleaching techniques. Oper Dent. 2010 Jan-Feb;35(1):3-10. doi: 10.2341/09-008CR.
- Background: PubMed 29568167Chowdhary Z, Mohan R. Efficiency of three different polishing methods on enamel and cementum: A scanning electron microscope study. J Indian Soc Periodontol. 2018 Jan-Feb;22(1):18-24. doi: 10.4103/jisp.jisp_40_17.
- Background: PubMed 18369668Wiegand A, Drebenstedt S, Roos M, Magalhaes AC, Attin T. 12-month color stability of enamel, dentine, and enamel-dentine samples after bleaching. Clin Oral Investig. 2008 Dec;12(4):303-10. doi: 10.1007/s00784-008-0195-7. Epub 2008 Mar 28.
- Related InfoLink provided by the sponsor.
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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?
A Phase 4 study testing AIRFLOW® Master device +Opalescence Xtra Boost. and rubber-cup+Opalescence Xtra Boost. in people with Tooth Discoloration and Color Changes During Tooth Formation, run by Cukurova 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 3 inclusion and 7 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 29 May 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ΔE (time frame: 1 week). 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 NCT04407910, 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 29 May 2020.