Enamel HypoplasiaNCT06987448
Clinical Comparison of CAD/CAM Nanohybrid Composite and Hybrid Ceramic Overlays in Children With Molar-Incisor Hypomineralisation
A study testing Semi-direct onlay restoration using CAD/CAM hybrid composite block and Semi-direct onlay restoration using CAD/CAM hybrid ceramic block in people with Enamel Hypoplasia and Molar-Incisor Hypomineralization (MIH), run by Alp Akça at 1 site in Turkey (Türkiye).
Trial summary
This clinical study was conducted to compare two different dental materials used in the treatment of children who have a condition called molar-incisor hypomineralization (MIH). MIH affects the quality of the enamel in permanent molars and can cause sensitivity, pain, and rapid tooth breakdown. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Enamel Hypoplasia, Molar-Incisor Hypomineralization (MIH), Restoration of Permanent Molars Affected by MIH With CAD/CAM Blocks
- What is being tested?
- Semi-direct onlay restoration using CAD/CAM hybrid composite block and Semi-direct onlay restoration using CAD/CAM hybrid ceramic block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2023to 11 Sep 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 8 and 13 years
- Presence of at least two permanent first molars affected by MIH
- MIH-affected molars classified as score 2b, 2c, 4b, or 4c according to the MIH-TNI index
- Symmetrical molars suitable for split-mouth comparison
- Cooperative behavior sufficient to allow treatment under local anesthesia
- Signed informed consent obtained from parent or legal guardian
Who cannot join
- Presence of systemic or syndromic diseases affecting enamel development
- History of bruxism or parafunctional habits
- Presence of pulp involvement, fistula, or periapical pathology in the target teeth
- Allergies to dental materials used in the study (e.g., resin-based composites, adhesives)
- Participation in another clinical trial within the past 30 days
- Inability to attend scheduled follow-up appointments at 6, 12, and 18 months
- Use of medication affecting pain perception or healing process
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, School of Dentistry, Department of Pediatric Dentistry. Marmara Üniversitesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL.
Istanbul, Istanbul, 34854
About this study
Official title: Clinical Comparison of CAD/CAM Nanohybrid Composite and Hybrid Ceramic Overlays in Children With Molar-Incisor Hypomineralisation: a Split-mouth Prospective Randomized Clinical Trial
This clinical study was conducted to compare two different dental materials used in the treatment of children who have a condition called molar-incisor hypomineralization (MIH). MIH affects the quality of the enamel in permanent molars and can cause sensitivity, pain, and rapid tooth breakdown. In this study, children between the ages of 8 and 13 who had MIH in at least two molars received two types of onlay restorations: one made from a hybrid composite block and the other from a hybrid ceramic block. Both restorations were designed and manufactured using a digital system called CAD/CAM, which allows for more precise and efficient dental treatment.
Each child received both types of restorations-one on each side of the mouth-in a split-mouth design. The goal was to see how well each material worked over a period of six months. The restorations were evaluated by trained dentists using clinical criteria, and the children were also assessed for tooth sensitivity using a cold air test.
The main purpose of this study was to find out which material provides better clinical performance and reduces tooth sensitivity more effectively.
Read the detailed description
Molar-Incisor Hypomineralization (MIH) is a developmental enamel defect that primarily affects the first permanent molars and frequently the incisors. It is characterized by hypomineralized enamel with increased porosity, discoloration, and a high risk of post-eruptive enamel breakdown. Affected teeth often present with significant sensitivity, posing difficulties in achieving adequate anesthesia and effective bonding during restorative procedures. As a result, the management of MIH-affected molars in pediatric patients is both complex and clinically significant.
This prospective, randomized, split-mouth clinical study was designed to compare two different CAD/CAM materials used in semi-direct onlay restorations for the treatment of MIH-affected molars in children aged 8 to 13 years. The materials under investigation were a nano-hybrid composite block (Grandio blocs, VOCO) and a polymer-infiltrated ceramic network (PICN) hybrid ceramic block (VITA Enamic, VITA Zahnfabrik).
The study enrolled 20 pediatric patients, each presenting with at least two permanent first molars affected by MIH (classified as score 2b/c or 4b/c according to the MIH-TNI criteria). Using a split-mouth design, each patient received both interventions-one molar restored with a hybrid composite block and the other with a hybrid ceramic block. Randomization was performed using a computer-generated sequence. All procedures were carried out by a trained pediatric dentistry resident under rubber dam isolation, following a standardized adhesive protocol.
The restorative process was completed in a single session and followed a fully digital workflow. Teeth were scanned intraorally using the CEREC system, and restorations were designed and milled chairside. Immediate dentin sealing (IDS) was applied prior to cementation. The internal surfaces of the restorations were prepared using appropriate surface treatments such as sandblasting or hydrofluoric acid etching followed by silane application, in accordance with the manufacturers' guidelines. Final cementation was performed using a dual-cure resin cement.
Follow-up evaluations are planned at 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 years. At each time point, clinical assessments are conducted by two calibrated, blinded evaluators using modified United States Public Health Service (USPHS) criteria. These include evaluations of marginal adaptation, surface integrity, anatomical form, marginal discoloration, and the presence of secondary caries. Additionally, thermal sensitivity is assessed using the Schiff Cold Air Sensitivity Scale to monitor changes in dentin hypersensitivity over time.
This study aims to provide comparative data on the mid-term clinical performance of two innovative restorative materials applied in MIH-affected molars using a minimally invasive, digital workflow.
- Conditions
- Enamel Hypoplasia, Molar-Incisor Hypomineralization (MIH), Restoration of Permanent Molars Affected by MIH With CAD/CAM Blocks
- Being tested
- Semi-direct onlay restoration using CAD/CAM hybrid composite block, Semi-direct onlay restoration using CAD/CAM hybrid ceramic block
- Keywords
- Molar-Incisor Hypomineralization, Pediatric Dentistry, Digital Workflow, Tooth Sensitivity, Immediate Dentin Sealing
- Medical subject headings
- Dental Enamel Hypoplasia, Molar Hypomineralization, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-direct onlay restoration using CAD/CAM hybrid composite blockProcedure or surgery
This refers to restorations fabricated from nano-ceramic hybrid composite blocks via chairside CAD/CAM workflow and cemented to permanent molars affected by MIH (molar-incisor hypomineralization).
Semi-direct onlay restoration using CAD/CAM hybrid ceramic blockProcedure or surgery
This refers to restorations fabricated from polymer-infiltrated hybrid ceramic blocks using a digital workflow, then cemented to MIH-affected permanent molars.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Composite Block Group (HCB) | Experimental | In this group, semi-direct onlay restorations were applied using nano-ceramic hybrid composite blocks (Grandio blocs, VOCO) fabricated through a CAD/CAM digital workflow. Following cavity preparation, dentin surfaces were sealed using the Immediate Dentin Sealing (IDS) technique. The restorations were cemented with a dual-cure resin cement Receives: Procedure: Semi-direct onlay restoration using CAD/CAM hybrid ceramic block |
| Hybrid Ceramic Block Group (HCB) | Experimental | In this group, onlay restorations were fabricated from polymer-infiltrated feldspathic ceramic blocks (VITA Enamic) using a CAD/CAM-assisted digital workflow. After hydrofluoric acid etching and silane application to the internal surface of the restoration, IDS-treated tooth surfaces were prepared for cementation. Restorations were bonded using a dual-cure resin cement. Receives: Procedure: Semi-direct onlay restoration using CAD/CAM hybrid composite block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of onlay restorations based on modified USPHS criteria
Assessment of the clinical acceptability of CAD/CAM-fabricated semi-direct onlay restorations using modified United States Public Health Service (USPHS) criteria, including Surface luster/roughness, Surface and marginal staining, Color match, Anatomic form, Fracture of restoration, Marginal adaptation, Patient's view, Postop. hypersensitivity and tooth vitality, Recurrence of erosion/caries and Fracture of tooth
Scores:
Acceptable:
- Perfect
- Good
- Acceptable Unacceptable (failed):
- Bad
- Gross
Measured: Baseline, and 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 years.
Secondary outcomes (2)
Dentin hypersensitivity assessed by the Schiff Cold Air Sensitivity Scale
Evaluation of thermal sensitivity in restored MIH-affected molars using the Schiff Cold Air Sensitivity Scale. The test involves applying a standardized air stimulus to the tooth surface and scoring the response on a scale from 0 to 3. Ordinal (Schiff scale: 0 = no response, 1 = response but no request to stop, 2 = response with request to stop, 3 = painful response)
Measured: Baseline (pre-treatment), and 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 years.
Intra-examiner and inter-examiner agreement on clinical evaluation criteria
Measurement of the consistency and reliability between two calibrated evaluators in assessing clinical performance using modified USPHS criteria. Agreement will be calculated using kappa statistics. Statistical agreement (Cohen's Kappa coefficient) Assessment of the clinical acceptability of CAD/CAM-fabricated semi-direct onlay restorations using modified United States Public Health Service (USPHS) criteria, including Surface luster/roughness, Surface and marginal staining, Color match, Anatomic form, Fracture of restoration, Marginal adaptation, Patient's view, Postop. hypersensitivity and tooth vitality, Recurrence of erosion/caries and Fracture of tooth
Scores:
Acceptable:
- Perfect
- Good
- Acceptable Unacceptable (failed):
- Bad
- Gross
Measured: Baseline, and 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start11 Sep 2023
- Primary completion15 Mar 2024
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enamel HypoplasiaStudies 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
- Model description
- The study involves the application of a hybrid composite CAD/CAM restoration to one of two permanent first molar teeth affected by MIH in each patient, and a hybrid ceramic CAD/CAM restoration to the other tooth.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alp Akça
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Sponsor-investigator, Alp Akça, Marmara University
- Investigators
- Alp Akça, Doctor of Dental Surgery (DDS), Principal investigator, Marmara University, School of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987448
- Sponsor's protocol ID
- MUPEDDENTALPAKCA
- Status last verified
- Oct 2026
- First submitted
- 7 May 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including intraoral photographs and clinical evaluation scores) may be shared in scientific publications or presentations. Data will be limited to information relevant for scientific analysis and will not include any personal identifiers.
Publications
Akca A, Eren F, Kargul B. Clinical comparison of CAD/CAM nanohybrid composite and hybrid ceramic overlays in children with molar-incisor hypomineralisation: a split-mouth prospective randomized clinical trial. Clin Oral Investig. 2026 Aug 7;30(9):374. doi: 10.1007/s00784-026-07067-4.
PubMed 42565852
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of CAD/CAM Nanohybrid Composite and Hybrid Ceramic Overlays in Children With Molar-Incisor Hypomineralisation: a Split-mouth Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06987448
- Acronym / sponsor ID
- MUPEDDENTALPAKCA
- Conditions
- Enamel Hypoplasia, Molar-Incisor Hypomineralization (MIH), Restoration of Permanent Molars Affected by MIH With CAD/CAM Blocks
- Keywords
- Molar-Incisor Hypomineralization, Pediatric Dentistry, Digital Workflow, Tooth Sensitivity, Immediate Dentin Sealing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alp AkçaUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 23 May 2025 (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.
This clinical study was conducted to compare two different dental materials used in the treatment of children who have a condition called molar-incisor hypomineralization (MIH). MIH affects the quality of the enamel in permanent molars and can cause sensitivity, pain, and rapid tooth breakdown. In this study, children between the ages of 8 and 13 who had MIH in at least two molars received two types of onlay restorations: one made from a hybrid composite block and the other from a hybrid ceramic block. Both restorations were designed and manufactured using a digital system called CAD/CAM, which allows for more precise and efficient dental treatment.
Each child received both types of restorations-one on each side of the mouth-in a split-mouth design. The goal was to see how well each material worked over a period of six months. The restorations were evaluated by trained dentists using clinical criteria, and the children were also assessed for tooth sensitivity using a cold air test.
The main purpose of this study was to find out which material provides better clinical performance and reduces tooth sensitivity more effectively.
Detailed description
Molar-Incisor Hypomineralization (MIH) is a developmental enamel defect that primarily affects the first permanent molars and frequently the incisors. It is characterized by hypomineralized enamel with increased porosity, discoloration, and a high risk of post-eruptive enamel breakdown. Affected teeth often present with significant sensitivity, posing difficulties in achieving adequate anesthesia and effective bonding during restorative procedures. As a result, the management of MIH-affected molars in pediatric patients is both complex and clinically significant.
This prospective, randomized, split-mouth clinical study was designed to compare two different CAD/CAM materials used in semi-direct onlay restorations for the treatment of MIH-affected molars in children aged 8 to 13 years. The materials under investigation were a nano-hybrid composite block (Grandio blocs, VOCO) and a polymer-infiltrated ceramic network (PICN) hybrid ceramic block (VITA Enamic, VITA Zahnfabrik).
The study enrolled 20 pediatric patients, each presenting with at least two permanent first molars affected by MIH (classified as score 2b/c or 4b/c according to the MIH-TNI criteria). Using a split-mouth design, each patient received both interventions-one molar restored with a hybrid composite block and the other with a hybrid ceramic block. Randomization was performed using a computer-generated sequence. All procedures were carried out by a trained pediatric dentistry resident under rubber dam isolation, following a standardized adhesive protocol.
The restorative process was completed in a single session and followed a fully digital workflow. Teeth were scanned intraorally using the CEREC system, and restorations were designed and milled chairside. Immediate dentin sealing (IDS) was applied prior to cementation. The internal surfaces of the restorations were prepared using appropriate surface treatments such as sandblasting or hydrofluoric acid etching followed by silane application, in accordance with the manufacturers' guidelines. Final cementation was performed using a dual-cure resin cement.
Follow-up evaluations are planned at 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 years. At each time point, clinical assessments are conducted by two calibrated, blinded evaluators using modified United States Public Health Service (USPHS) criteria. These include evaluations of marginal adaptation, surface integrity, anatomical form, marginal discoloration, and the presence of secondary caries. Additionally, thermal sensitivity is assessed using the Schiff Cold Air Sensitivity Scale to monitor changes in dentin hypersensitivity over time.
This study aims to provide comparative data on the mid-term clinical performance of two innovative restorative materials applied in MIH-affected molars using a minimally invasive, digital workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study involves the application of a hybrid composite CAD/CAM restoration to one of two permanent first molar teeth affected by MIH in each patient, and a hybrid ceramic CAD/CAM restoration to the other tooth.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Composite Block Group (HCB) | Experimental | Procedure: Semi-direct onlay restoration using CAD/CAM hybrid ceramic blockIn this group, semi-direct onlay restorations were applied using nano-ceramic hybrid composite blocks (Grandio blocs, VOCO) fabricated through a CAD/CAM digital workflow. Following cavity preparation, dentin surfaces were sealed using the Immediate Dentin Sealing (IDS) technique. The restorations were cemented with a dual-cure resin cement |
| Hybrid Ceramic Block Group (HCB) | Experimental | Procedure: Semi-direct onlay restoration using CAD/CAM hybrid composite blockIn this group, onlay restorations were fabricated from polymer-infiltrated feldspathic ceramic blocks (VITA Enamic) using a CAD/CAM-assisted digital workflow. After hydrofluoric acid etching and silane application to the internal surface of the restoration, IDS-treated tooth surfaces were prepared for cementation. Restorations were bonded using a dual-cure resin cement. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged between 8 and 13 years
- Presence of at least two permanent first molars affected by MIH
- MIH-affected molars classified as score 2b, 2c, 4b, or 4c according to the MIH-TNI index
- Symmetrical molars suitable for split-mouth comparison
- Cooperative behavior sufficient to allow treatment under local anesthesia
Key exclusion criteria (7 listed)
- Presence of systemic or syndromic diseases affecting enamel development
- History of bruxism or parafunctional habits
- Presence of pulp involvement, fistula, or periapical pathology in the target teeth
- Allergies to dental materials used in the study (e.g., resin-based composites, adhesives)
- Participation in another clinical trial within the past 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 |
|---|---|---|
| Semi-direct onlay restoration using CAD/CAM hybrid composite blockThis refers to restorations fabricated from nano-ceramic hybrid composite blocks via chairside CAD/CAM workflow and cemented to permanent molars affected by MIH (molar-incisor hypomineralization). | Procedure or surgery | Hybrid Ceramic Block Group (HCB) |
| Semi-direct onlay restoration using CAD/CAM hybrid ceramic blockThis refers to restorations fabricated from polymer-infiltrated hybrid ceramic blocks using a digital workflow, then cemented to MIH-affected permanent molars. | Procedure or surgery | Hybrid Composite Block Group (HCB) |
Primary outcome
Clinical performance of onlay restorations based on modified USPHS criteria
Time frame: Baseline, and 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 years.
Assessment of the clinical acceptability of CAD/CAM-fabricated semi-direct onlay restorations using modified United States Public Health Service (USPHS) criteria, including Surface luster/roughness, Surface and marginal staining, Color match, Anatomic form, Fracture of restoration, Marginal adaptation, Patient's view, Postop. hypersensitivity and tooth vitality, Recurrence of erosion/caries and Fracture of tooth Scores: Acceptable: 1. Perfect 2. Good 3. Acceptable Unacceptable (failed): 4. Bad 5. Gross
2 secondary outcomes
Dentin hypersensitivity assessed by the Schiff Cold Air Sensitivity Scale
Time frame: Baseline (pre-treatment), and 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 years.
Intra-examiner and inter-examiner agreement on clinical evaluation criteria
Time frame: Baseline, and 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 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 20 Oct 2026.
- Derived from this study: PubMed 42565852Akca A, Eren F, Kargul B. Clinical comparison of CAD/CAM nanohybrid composite and hybrid ceramic overlays in children with molar-incisor hypomineralisation: a split-mouth prospective randomized clinical trial. Clin Oral Investig. 2026 Aug 7;30(9):374. doi: 10.1007/s00784-026-07067-4.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including intraoral photographs and clinical evaluation scores) may be shared in scientific publications or presentations. Data will be limited to information relevant for scientific analysis and will not include any personal identifiers.
Related trials for Enamel Hypoplasia
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
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.
Alp Akça, Doctor of Dental Surgery (DDS) principal investigator
Marmara University, School of Dentistry, Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-direct onlay restoration using CAD/CAM hybrid composite block and Semi-direct onlay restoration using CAD/CAM hybrid ceramic block in people with Enamel Hypoplasia and Molar-Incisor Hypomineralization (MIH), run by Alp Akça 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 6 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 20 Oct 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of onlay restorations based on modified USPHS criteria (time frame: Baseline, and 6-month intervals over a 5-year postoperative period, with continued long-term follow-up beyond the initial 5 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 NCT06987448, which also lists 1 linked publication.
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 Oct 2026.