Abrasion, DentalNCT06107218
Performance Of Class I Composite Restorations After Cavity Finishing By Air Abrasion Versus Diamond Stone
A study testing Bioactive Glass Air Abrasion Particles. and Diamond Stone. in people with Abrasion, Dental and Class I Dental Caries, run by Cairo University.
Trial summary
The aim of the study is to reveal the performance of the resin composite restorations after finishing the cavity walls and margins using bioactive glass air abrasion particles in comparison to the routine finishing with the finishing diamond stone according to the FDI criteria for post operative sensitivity, marginal… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Abrasion, Dental, Class I Dental Caries
- What is being tested?
- Bioactive Glass Air Abrasion Particles. and Diamond Stone.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jun 2025
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral hygiene (plaque index score 0 or 1).
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Patients approving to participate in the study.
Who cannot join
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Performance Of Occlusal Resin Composite Restorations Following Cavity Finishing Using Bioactive Glass Air Abrasion Versus Diamond Stone: A Randomized Controlled Trial
The aim of the study is to reveal the performance of the resin composite restorations after finishing the cavity walls and margins using bioactive glass air abrasion particles in comparison to the routine finishing with the finishing diamond stone according to the FDI criteria for post operative sensitivity, marginal adaptation, marginal discoloration, secondary caries, and retention.
Read the detailed description
Intraoral air abrasion is the process of altering the surface of the tooth structure through the use of abrasive particles propelled by compressed air or other gasses. The use of intraoral air abrasion has become practical with devices that simultaneously output abrasive particles and water to control the spread of the particles. There are different types of abrasive particles maybe used depending on the clinical application for which the intraoral air abrasion is being performed. Intraoral air abrasion may also be used as a tool for dental prophylaxis, often called air polishing.
Different particles could be incorporated into air abrasion devices according to the intended use of them, such as aluminum oxide (alumina), Calcium Sodium Phosphosilicate (Biactive Glass) and Sodium bicarbonate. To obtain maximum cutting efficiency, the particle should be hard enough to indent the substrate it abrades, and irregular in shape with a sharp cutting edge. Round and smooth particles possess poor abrasive properties, so it may be used for polishing needs "air- polishing". Increased air pressure provided an increased number and velocity of the particles. Abrading power must be proportional to kinetic energy of the particles, which is the function of mass and velocity of the particle. The cutting efficiency of air abrasion depends on several criteria, such as: size, shape, hardness, density of the particles and air pressure.
Aluminum oxide (alumina) are the most abrasive type of particles used. They are irregular in shape with different particle sizes. Intraoral sandblasting with alumina particles (Al2O3) was first described in 1945 by Black. Initially, it was reported that the bond strength to the tooth surface improved, also confirmed by recent investigations, and some authors adopted its use in clinical procedures even after preparing the cavity with rotating instrument. A bioactive glass abrasive, is also commercially available but indicated for the purpose of tooth polishing. Some work has also showed potential for it to have selective cutting properties. However, its cutting time can take 2-3 times longer than alumina, making it clinically indicated for cavity finishing and not cutting.
- Conditions
- Abrasion, Dental, Class I Dental Caries
- Being tested
- Bioactive Glass Air Abrasion Particles., Diamond Stone.
- Medical subject headings
- Tooth Abrasion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive Glass Air Abrasion Particles.Other
Finishing of cavity walls by AquaCare Air Abrasion Device using Bioactive Glass Air Abrasion Particles.
Diamond Stone.Other
Finishing of cavity walls using Diamond Stone.
| Study group | Role | What they receive |
|---|---|---|
| Diamond Stone group (Comparator) | Active comparator | Class I cavities will be finished using 20-30 μm grit extra fine (EF) yellow coded diamond stone with maximum rotational speed 300,000 min -1. Receives: Other: Diamond Stone. |
| Bioactive Glass Air Abrasion group (Intervention) | Active comparator | Class I cavities will be finished by AquaCare Air Abrasion Device using bioactive glass air-abrasion particles (a mix of 30-60-90 μm particles). The nozzle of the air abrasion device will be 0.6 in diameter and angulated at 90° to the occlusal surface with a distance away from the tooth about 2-3 mm. The device will be used in a dynamic motion with 60 psi (4 Bar) adjusted pressure for 3 seconds. Receives: Other: Bioactive Glass Air Abrasion Particles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity.
The restorations will be assessed and evaluated by Visual Analogue Scale using Federation Dentaire Internationale (FDI) criteria. Visual Analogue Scale will be used by scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
Measured: 24 hours Baseline, 6 and 12 months.
Secondary outcomes (4)
Marginal Discoloration.
The restorations will be assessed by visual examination and short air drying. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Measured: 24 hours Baseline, 6, 12 and 18 months.
Marginal Adaptation.
The Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Measured: 24 hours Baseline, 6, 12 and 18 months.
Occurrence of Caries.
The Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Measured: 24 hours Baseline, 6, 12 and 18 months.
Loss of Retention.
The restorations will be assessed by visual examination and short air drying. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Measured: 24 hours Baseline, 6, 12 and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (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 Abrasion, DentalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Essam Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107218
- Sponsor's protocol ID
- Air Abrasion in Finishing
- Status last verified
- Nov 2023
- First submitted
- 10 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang CT, Kim J, Arce C, Lawson NC. Intraoral Air Abrasion: A Review of Devices, Materials, Evidence, and Clinical Applications in Restorative Dentistry. Compend Contin Educ Dent. 2019 Sep;40(8):508-513; quiz 514.
PubMed 31478697Paolinelis G, Banerjee A, Watson TF. An in vitro investigation of the effect and retention of bioactive glass air-abrasive on sound and carious dentine. J Dent. 2008 Mar;36(3):214-8. doi: 10.1016/j.jdent.2007.12.004. Epub 2008 Jan 30.
PubMed 18237840Banerjee A, Pabari H, Paolinelis G, Thompson ID, Watson TF. An in vitro evaluation of selective demineralised enamel removal using bio-active glass air abrasion. Clin Oral Investig. 2011 Dec;15(6):895-900. doi: 10.1007/s00784-010-0470-2. Epub 2010 Oct 13.
PubMed 20941634Banerjee A, Thompson ID, Watson TF. Minimally invasive caries removal using bio-active glass air-abrasion. J Dent. 2011 Jan;39(1):2-7. doi: 10.1016/j.jdent.2010.09.004. Epub 2010 Oct 1.
PubMed 20888883Milly H, Austin RS, Thompson I, Banerjee A. In vitro effect of air-abrasion operating parameters on dynamic cutting characteristics of alumina and bio-active glass powders. Oper Dent. 2014 Jan-Feb;39(1):81-9. doi: 10.2341/12-466-L. Epub 2013 May 29.
PubMed 23718212Lynch CD, Opdam NJ, Hickel R, Brunton PA, Gurgan S, Kakaboura A, Shearer AC, Vanherle G, Wilson NH; Academy of Operative Dentistry European Section. Guidance on posterior resin composites: Academy of Operative Dentistry - European Section. J Dent. 2014 Apr;42(4):377-83. doi: 10.1016/j.jdent.2014.01.009. Epub 2014 Jan 22.
PubMed 24462699da Rosa Rodolpho PA, Cenci MS, Donassollo TA, Loguercio AD, Demarco FF. A clinical evaluation of posterior composite restorations: 17-year findings. J Dent. 2006 Aug;34(7):427-35. doi: 10.1016/j.jdent.2005.09.006. Epub 2005 Nov 28.
PubMed 16314023Hofsteenge JW, Scholtanus JD, Ozcan M, Nolte IM, Cune MS, Gresnigt MMM. Clinical longevity of extensive direct resin composite restorations after amalgam replacement with a mean follow-up of 15 years. J Dent. 2023 Mar;130:104409. doi: 10.1016/j.jdent.2023.104409. Epub 2023 Jan 6.
PubMed 36623686Hardan L, Sidawi L, Akhundov M, Bourgi R, Ghaleb M, Dabbagh S, Sokolowski K, Cuevas-Suarez CE, Lukomska-Szymanska M. One-Year Clinical Performance of the Fast-Modelling Bulk Technique and Composite-Up Layering Technique in Class I Cavities. Polymers (Basel). 2021 Jun 4;13(11):1873. doi: 10.3390/polym13111873.
PubMed 34200021Van Meerbeek B, De Munck J, Mattar D, Van Landuyt K, Lambrechts P. Microtensile bond strengths of an etch&rinse and self-etch adhesive to enamel and dentin as a function of surface treatment. Oper Dent. 2003 Sep-Oct;28(5):647-60.
PubMed 14531614Graumann SJ, Sensat ML, Stoltenberg JL. Air polishing: a review of current literature. J Dent Hyg. 2013 Aug;87(4):173-80.
PubMed 23986410Bendinskaite R, Peciuliene V, Brukiene V. A five years clinical evaluation of sealed occlusal surfaces of molars. Stomatologija. 2010;12(3):87-92.
PubMed 21063138Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
PubMed 16315023Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.
PubMed 18341239Marquillier T, Domejean S, Le Clerc J, Chemla F, Gritsch K, Maurin JC, Millet P, Perard M, Grosgogeat B, Dursun E. The use of FDI criteria in clinical trials on direct dental restorations: A scoping review. J Dent. 2018 Jan;68:1-9. doi: 10.1016/j.jdent.2017.10.007. Epub 2017 Oct 18.
PubMed 29055692
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Of Occlusal Resin Composite Restorations Following Cavity Finishing Using Bioactive Glass Air Abrasion Versus Diamond Stone: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06107218
- Acronym / sponsor ID
- Air Abrasion in Finishing
- Conditions
- Abrasion, Dental, Class I Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Oct 2023 (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 aim of the study is to reveal the performance of the resin composite restorations after finishing the cavity walls and margins using bioactive glass air abrasion particles in comparison to the routine finishing with the finishing diamond stone according to the FDI criteria for post operative sensitivity, marginal adaptation, marginal discoloration, secondary caries, and retention.
Detailed description
Intraoral air abrasion is the process of altering the surface of the tooth structure through the use of abrasive particles propelled by compressed air or other gasses. The use of intraoral air abrasion has become practical with devices that simultaneously output abrasive particles and water to control the spread of the particles. There are different types of abrasive particles maybe used depending on the clinical application for which the intraoral air abrasion is being performed. Intraoral air abrasion may also be used as a tool for dental prophylaxis, often called air polishing.
Different particles could be incorporated into air abrasion devices according to the intended use of them, such as aluminum oxide (alumina), Calcium Sodium Phosphosilicate (Biactive Glass) and Sodium bicarbonate. To obtain maximum cutting efficiency, the particle should be hard enough to indent the substrate it abrades, and irregular in shape with a sharp cutting edge. Round and smooth particles possess poor abrasive properties, so it may be used for polishing needs "air- polishing". Increased air pressure provided an increased number and velocity of the particles. Abrading power must be proportional to kinetic energy of the particles, which is the function of mass and velocity of the particle. The cutting efficiency of air abrasion depends on several criteria, such as: size, shape, hardness, density of the particles and air pressure.
Aluminum oxide (alumina) are the most abrasive type of particles used. They are irregular in shape with different particle sizes. Intraoral sandblasting with alumina particles (Al2O3) was first described in 1945 by Black. Initially, it was reported that the bond strength to the tooth surface improved, also confirmed by recent investigations, and some authors adopted its use in clinical procedures even after preparing the cavity with rotating instrument. A bioactive glass abrasive, is also commercially available but indicated for the purpose of tooth polishing. Some work has also showed potential for it to have selective cutting properties. However, its cutting time can take 2-3 times longer than alumina, making it clinically indicated for cavity finishing and not cutting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diamond Stone group (Comparator) | Active comparator | Other: Diamond Stone.Class I cavities will be finished using 20-30 μm grit extra fine (EF) yellow coded diamond stone with maximum rotational speed 300,000 min -1. |
| Bioactive Glass Air Abrasion group (Intervention) | Active comparator | Other: Bioactive Glass Air Abrasion Particles.Class I cavities will be finished by AquaCare Air Abrasion Device using bioactive glass air-abrasion particles (a mix of 30-60-90 μm particles). The nozzle of the air abrasion device will be 0.6 in diameter and angulated at 90° to the occlusal surface with a distance away from the tooth about 2-3 mm. The device will be used in a dynamic motion with 60 psi (4 Bar) adjusted pressure for 3 seconds. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good oral hygiene (plaque index score 0 or 1).
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Patients approving to participate in the study.
Key exclusion criteria (3 listed)
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
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 |
|---|---|---|
| Bioactive Glass Air Abrasion Particles.Finishing of cavity walls by AquaCare Air Abrasion Device using Bioactive Glass Air Abrasion Particles. | Other | Bioactive Glass Air Abrasion group (Intervention) |
| Diamond Stone.Finishing of cavity walls using Diamond Stone. | Other | Diamond Stone group (Comparator) |
Primary outcome
Post-operative sensitivity.
Time frame: 24 hours Baseline, 6 and 12 months.
The restorations will be assessed and evaluated by Visual Analogue Scale using Federation Dentaire Internationale (FDI) criteria. Visual Analogue Scale will be used by scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
4 secondary outcomes
Marginal Discoloration.
Time frame: 24 hours Baseline, 6, 12 and 18 months.
Marginal Adaptation.
Time frame: 24 hours Baseline, 6, 12 and 18 months.
Occurrence of Caries.
Time frame: 24 hours Baseline, 6, 12 and 18 months.
Loss of Retention.
Time frame: 24 hours Baseline, 6, 12 and 18 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 31478697Huang CT, Kim J, Arce C, Lawson NC. Intraoral Air Abrasion: A Review of Devices, Materials, Evidence, and Clinical Applications in Restorative Dentistry. Compend Contin Educ Dent. 2019 Sep;40(8):508-513; quiz 514.
- Background: PubMed 18237840Paolinelis G, Banerjee A, Watson TF. An in vitro investigation of the effect and retention of bioactive glass air-abrasive on sound and carious dentine. J Dent. 2008 Mar;36(3):214-8. doi: 10.1016/j.jdent.2007.12.004. Epub 2008 Jan 30.
- Background: PubMed 20941634Banerjee A, Pabari H, Paolinelis G, Thompson ID, Watson TF. An in vitro evaluation of selective demineralised enamel removal using bio-active glass air abrasion. Clin Oral Investig. 2011 Dec;15(6):895-900. doi: 10.1007/s00784-010-0470-2. Epub 2010 Oct 13.
- Background: PubMed 20888883Banerjee A, Thompson ID, Watson TF. Minimally invasive caries removal using bio-active glass air-abrasion. J Dent. 2011 Jan;39(1):2-7. doi: 10.1016/j.jdent.2010.09.004. Epub 2010 Oct 1.
- Background: PubMed 23718212Milly H, Austin RS, Thompson I, Banerjee A. In vitro effect of air-abrasion operating parameters on dynamic cutting characteristics of alumina and bio-active glass powders. Oper Dent. 2014 Jan-Feb;39(1):81-9. doi: 10.2341/12-466-L. Epub 2013 May 29.
- Background: PubMed 24462699Lynch CD, Opdam NJ, Hickel R, Brunton PA, Gurgan S, Kakaboura A, Shearer AC, Vanherle G, Wilson NH; Academy of Operative Dentistry European Section. Guidance on posterior resin composites: Academy of Operative Dentistry - European Section. J Dent. 2014 Apr;42(4):377-83. doi: 10.1016/j.jdent.2014.01.009. Epub 2014 Jan 22.
- Background: PubMed 16314023da Rosa Rodolpho PA, Cenci MS, Donassollo TA, Loguercio AD, Demarco FF. A clinical evaluation of posterior composite restorations: 17-year findings. J Dent. 2006 Aug;34(7):427-35. doi: 10.1016/j.jdent.2005.09.006. Epub 2005 Nov 28.
- Background: PubMed 36623686Hofsteenge JW, Scholtanus JD, Ozcan M, Nolte IM, Cune MS, Gresnigt MMM. Clinical longevity of extensive direct resin composite restorations after amalgam replacement with a mean follow-up of 15 years. J Dent. 2023 Mar;130:104409. doi: 10.1016/j.jdent.2023.104409. Epub 2023 Jan 6.
- Background: PubMed 34200021Hardan L, Sidawi L, Akhundov M, Bourgi R, Ghaleb M, Dabbagh S, Sokolowski K, Cuevas-Suarez CE, Lukomska-Szymanska M. One-Year Clinical Performance of the Fast-Modelling Bulk Technique and Composite-Up Layering Technique in Class I Cavities. Polymers (Basel). 2021 Jun 4;13(11):1873. doi: 10.3390/polym13111873.
- Background: PubMed 14531614Van Meerbeek B, De Munck J, Mattar D, Van Landuyt K, Lambrechts P. Microtensile bond strengths of an etch&rinse and self-etch adhesive to enamel and dentin as a function of surface treatment. Oper Dent. 2003 Sep-Oct;28(5):647-60.
- 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 21063138Bendinskaite R, Peciuliene V, Brukiene V. A five years clinical evaluation of sealed occlusal surfaces of molars. Stomatologija. 2010;12(3):87-92.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Glass Air Abrasion Particles. and Diamond Stone. in people with Abrasion, Dental and Class I Dental Caries, 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 3 inclusion and 3 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 Nov 2023. 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 Mahmoud E Mahmoud, BDS (01226692855, mahmoud.essam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative sensitivity. (time frame: 24 hours Baseline, 6 and 12 months.). 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 NCT06107218, 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 Nov 2023.