Dental Restoration Failure of Marginal IntegritySEALBULKNCT03924830
Influence of Surface Sealants on the Quality of Posterior Restorations With Bulk Fill Composites
A study testing Bulk without surface sealant, Bulk with Biscover and Bulk with Permaseal in people with Dental Restoration Failure of Marginal Integrity, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
Treatment clinical trial, randomized, controled, parallel, double-blinded, with three groups, that aims to evaluate if there is some advantage in applying surface sealants (Biscover, Bisco, USA or Permaseal, Ultradent, USA) associated with a Bulk Fill Composite (Tetric N-Ceram Bulk Fill, Ivoclar… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Bulk without surface sealant, Bulk with Biscover and Bulk with Permaseal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 8 May 2026
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients must have at only 20 teeth in function, must have at only 3 carious occlusal or proximo-occlusal lesions, or old restorations that need to be changed, in different teeth. Those lesions must be more than 2 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility.
Who cannot join
- Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory drugs in the last 30 days.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense - School of Dentistry
Nova Friburgo, Rio de Janeiro, 28625-650
About this study
Treatment clinical trial, randomized, controled, parallel, double-blinded, with three groups, that aims to evaluate if there is some advantage in applying surface sealants (Biscover, Bisco, USA or Permaseal, Ultradent, USA) associated with a Bulk Fill Composite (Tetric N-Ceram Bulk Fill, Ivoclar Vivadent,Liechtenstein). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. 53 enrolled patients will receive 159 Class I or Class II dental restorations, made in three different ways, one from each experimental group (no sealant, or one of the evaluated surface sealants). Occlusal or Proximo-occlusal lesions will receive the selected treatments separated by groups. Group Bulk without surface sealant (BNS), Group Bulk and Biscover (BSB), and Group Bulk and Permaseal (BSP). Immediate post-operative tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6 months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.
Read the detailed description
This is a Treatment clinical trial, randomized, controlled, parallel, double-blinded, with three groups, that aims to evaluate if there is some advantage in applying surface sealants (Biscover, Bisco, USA or Permaseal, Ultradent, USA) associated with a Bulk Fill Composite (Tetric N-Ceram Bulk Fill, Ivoclar Vivadent, Liechtenstein). Volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. All 53 enrolled patients will receive 159 Class I or Class II dental restorations, made in three different ways, one from each experimental group, using the same self-etching adhesive system, under the restorations that will use the same bulk fill composite. All patients must have at only 20 teeth in function, must have at only 3 carious lesion in occlusal or proximo-occlusal face in posterior teeth or old restorations in the same faces, with problems, that need to be changed. Those lesions must be more than 2 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with pumice powder and water. All cavities will be washed and dried after these procedures for optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth to be restored will be held. Occlusal or Proximo-occlusal lesions will receive the restorative procedurs in 3 different protocols separated by groups. Group Bulk without surface sealant (BNS): the adhesive system will be used in 53 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Tetric N-Ceram Bulk fill composite will be used in increments of 4 mm, using the bulk restoration technique, and photoactivated for 40 seconds; Group Bulk and Biscover (BSB): adhesive and restorative procedures will be performed as described in group BNS in 53 teeth. After the restorations are concluded, Biscover surface sealant will be applied according to the manufacturer's instructions; Group Bulk and Permaseal (BSP): adhesive and restorative procedures will be performed as described in group BNS in 53 teeth. After the restorations are concluded, Permaseal surface sealant will be applied according to the manufacturer's instructions. Immediate post-operative tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6 months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.
- Being tested
- Bulk without surface sealant, Bulk with Biscover, Bulk with Permaseal
- Keywords
- dentin bonding agents, tooth sensitivity, composite resin restoration
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk without surface sealantProcedure or surgery
Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds.
Bulk with BiscoverProcedure or surgery
Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, biscover surface sealant will be applied according to the manufacturer's instructions.
Bulk with PermasealProcedure or surgery
Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, Permaseal surface sealant will be applied according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Bulk without Surface Sealant | Active comparator | 53 teeth will receive restorations using Bulk fill restoration without surface sealant Receives: Procedure: Bulk without surface sealant |
| Bulk with Biscover | Experimental | 53 teeth will receive restorations using Bulk fill restoration with Biscover surface sealant Receives: Procedure: Bulk with Biscover |
| Bulk with Permaseal | Experimental | 53 teeth will receive restorations using Bulk fill restoration with Permaseal surface sealant Receives: Procedure: Bulk with Permaseal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration Loss
It will be evaluated the increase in the number of losses of dental restorations in the period of five years, verified by periodic visual clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of remaining restorations in the different groups.
Measured: Five years
Secondary outcomes (3)
Marginal Pigmentation
It will be evaluated the increase in the number of dental restorations with marginal pigmentation in the period of five years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
Measured: Five years
Post-Operative Hypersensitivity
It will be evaluated the increase in the number of dental restorations with dentin hypersensitivity in the period of five years, verified by periodic clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with dentin hypersensitivity in the different groups.
Measured: Five years
Secondary Caries
It will be evaluated the increase in the number of dental restorations with secondary caries in the period of five years, verified by periodic radiographic examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with secondary caries in the different groups.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Aug 2018
- Primary completion30 Mar 2019
- Study completion8 May 2026
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 Dental Restoration Failure of Marginal IntegrityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCOS O BARCELEIRO, DDS, PHD, Study director, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924830
- Sponsor's protocol ID
- UFFBULKSEAL2018
- Acronym
- SEALBULK
- Status last verified
- May 2026
- First submitted
- 18 Apr 2019
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbas G, Fleming GJ, Harrington E, Shortall AC, Burke FJ. Cuspal movement and microleakage in premolar teeth restored with a packable composite cured in bulk or in increments. J Dent. 2003 Aug;31(6):437-44. doi: 10.1016/s0300-5712(02)00121-5.
PubMed 12878027Moorthy A, Hogg CH, Dowling AH, Grufferty BF, Benetti AR, Fleming GJ. Cuspal deflection and microleakage in premolar teeth restored with bulk-fill flowable resin-based composite base materials. J Dent. 2012 Jun;40(6):500-5. doi: 10.1016/j.jdent.2012.02.015. Epub 2012 Mar 3.
PubMed 22390980Roggendorf MJ, Kramer N, Appelt A, Naumann M, Frankenberger R. Marginal quality of flowable 4-mm base vs. conventionally layered resin composite. J Dent. 2011 Oct;39(10):643-7. doi: 10.1016/j.jdent.2011.07.004. Epub 2011 Jul 27.
PubMed 21801799van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.
PubMed 25625133Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.
PubMed 26800647Costa T, Rezende M, Sakamoto A, Bittencourt B, Dalzochio P, Loguercio AD, Reis A. Influence of Adhesive Type and Placement Technique on Postoperative Sensitivity in Posterior Composite Restorations. Oper Dent. 2017 Mar/Apr;42(2):143-154. doi: 10.2341/16-010-C. Epub 2016 Nov 28.
PubMed 27892839Calazans FS, Ferreira TMJ, Naupari-Villasante R, Mendonca RP, Ornellas G, Albuquerque EG, Tardem C, de Miranda MS, Barceleiro MO, Loguercio AD. Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dent Mater. 2024 Mar;40(3):466-476. doi: 10.1016/j.dental.2023.12.011. Epub 2023 Dec 22.
PubMed 38142146
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Surface Sealants on the Quality of Posterior Restorations With Bulk Fill Composites
- ClinicalTrials.gov ID
- NCT03924830
- Acronym / sponsor ID
- SEALBULK / UFFBULKSEAL2018
- Keywords
- dentin bonding agents, tooth sensitivity, composite resin restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 23 Apr 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.
Treatment clinical trial, randomized, controled, parallel, double-blinded, with three groups, that aims to evaluate if there is some advantage in applying surface sealants (Biscover, Bisco, USA or Permaseal, Ultradent, USA) associated with a Bulk Fill Composite (Tetric N-Ceram Bulk Fill, Ivoclar Vivadent,Liechtenstein). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. 53 enrolled patients will receive 159 Class I or Class II dental restorations, made in three different ways, one from each experimental group (no sealant, or one of the evaluated surface sealants). Occlusal or Proximo-occlusal lesions will receive the selected treatments separated by groups. Group Bulk without surface sealant (BNS), Group Bulk and Biscover (BSB), and Group Bulk and Permaseal (BSP). Immediate post-operative tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6 months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.
Detailed description
This is a Treatment clinical trial, randomized, controlled, parallel, double-blinded, with three groups, that aims to evaluate if there is some advantage in applying surface sealants (Biscover, Bisco, USA or Permaseal, Ultradent, USA) associated with a Bulk Fill Composite (Tetric N-Ceram Bulk Fill, Ivoclar Vivadent, Liechtenstein). Volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. All 53 enrolled patients will receive 159 Class I or Class II dental restorations, made in three different ways, one from each experimental group, using the same self-etching adhesive system, under the restorations that will use the same bulk fill composite. All patients must have at only 20 teeth in function, must have at only 3 carious lesion in occlusal or proximo-occlusal face in posterior teeth or old restorations in the same faces, with problems, that need to be changed. Those lesions must be more than 2 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with pumice powder and water. All cavities will be washed and dried after these procedures for optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth to be restored will be held. Occlusal or Proximo-occlusal lesions will receive the restorative procedurs in 3 different protocols separated by groups. Group Bulk without surface sealant (BNS): the adhesive system will be used in 53 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Tetric N-Ceram Bulk fill composite will be used in increments of 4 mm, using the bulk restoration technique, and photoactivated for 40 seconds; Group Bulk and Biscover (BSB): adhesive and restorative procedures will be performed as described in group BNS in 53 teeth. After the restorations are concluded, Biscover surface sealant will be applied according to the manufacturer's instructions; Group Bulk and Permaseal (BSP): adhesive and restorative procedures will be performed as described in group BNS in 53 teeth. After the restorations are concluded, Permaseal surface sealant will be applied according to the manufacturer's instructions. Immediate post-operative tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6 months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bulk without Surface Sealant | Active comparator | Procedure: Bulk without surface sealant53 teeth will receive restorations using Bulk fill restoration without surface sealant |
| Bulk with Biscover | Experimental | Procedure: Bulk with Biscover53 teeth will receive restorations using Bulk fill restoration with Biscover surface sealant |
| Bulk with Permaseal | Experimental | Procedure: Bulk with Permaseal53 teeth will receive restorations using Bulk fill restoration with Permaseal surface sealant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients must have at only 20 teeth in function, must have at only 3 carious occlusal or proximo-occlusal lesions, or old restorations that need to be changed, in different teeth. Those lesions must be more than 2 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility.
Key exclusion criteria (1 listed)
- Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory drugs in the last 30 days.
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 |
|---|---|---|
| Bulk without surface sealantAdhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. | Procedure or surgery | Bulk without Surface Sealant |
| Bulk with BiscoverAdhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, biscover surface sealant will be applied according to the manufacturer's instructions. | Procedure or surgery | Bulk with Biscover |
| Bulk with PermasealAdhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, Permaseal surface sealant will be applied according to the manufacturer's instructions. | Procedure or surgery | Bulk with Permaseal |
Primary outcome
Restoration Loss
Time frame: Five years
It will be evaluated the increase in the number of losses of dental restorations in the period of five years, verified by periodic visual clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of remaining restorations in the different groups.
3 secondary outcomes
Marginal Pigmentation
Time frame: Five years
Post-Operative Hypersensitivity
Time frame: Five years
Secondary Caries
Time frame: Five years
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 15 May 2026.
- Background: PubMed 12878027Abbas G, Fleming GJ, Harrington E, Shortall AC, Burke FJ. Cuspal movement and microleakage in premolar teeth restored with a packable composite cured in bulk or in increments. J Dent. 2003 Aug;31(6):437-44. doi: 10.1016/s0300-5712(02)00121-5.
- Background: PubMed 22390980Moorthy A, Hogg CH, Dowling AH, Grufferty BF, Benetti AR, Fleming GJ. Cuspal deflection and microleakage in premolar teeth restored with bulk-fill flowable resin-based composite base materials. J Dent. 2012 Jun;40(6):500-5. doi: 10.1016/j.jdent.2012.02.015. Epub 2012 Mar 3.
- Background: PubMed 21801799Roggendorf MJ, Kramer N, Appelt A, Naumann M, Frankenberger R. Marginal quality of flowable 4-mm base vs. conventionally layered resin composite. J Dent. 2011 Oct;39(10):643-7. doi: 10.1016/j.jdent.2011.07.004. Epub 2011 Jul 27.
- Background: PubMed 25625133van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.
- Background: PubMed 26800647Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.
- Background: PubMed 27892839Costa T, Rezende M, Sakamoto A, Bittencourt B, Dalzochio P, Loguercio AD, Reis A. Influence of Adhesive Type and Placement Technique on Postoperative Sensitivity in Posterior Composite Restorations. Oper Dent. 2017 Mar/Apr;42(2):143-154. doi: 10.2341/16-010-C. Epub 2016 Nov 28.
- Derived from this study: PubMed 38142146Calazans FS, Ferreira TMJ, Naupari-Villasante R, Mendonca RP, Ornellas G, Albuquerque EG, Tardem C, de Miranda MS, Barceleiro MO, Loguercio AD. Influence of surface sealants on the quality of posterior restorations with bulk-fill composites: A 4-year randomized clinical trial. Dent Mater. 2024 Mar;40(3):466-476. doi: 10.1016/j.dental.2023.12.011. Epub 2023 Dec 22.
- 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.
MARCOS O BARCELEIRO, DDS, PHD study director
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulk without surface sealant, Bulk with Biscover and Bulk with Permaseal in people with Dental Restoration Failure of Marginal Integrity, run by Universidade Federal Fluminense at 1 site in Brazil.
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 1 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 15 May 2026. 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 Brazil. 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?
Restoration Loss (time frame: Five years). 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 NCT03924830, 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 15 May 2026.