Composite ResinsNCT06884787
Color Adjusting Resin Composite in Anterior Tooth Restorations: Clinical and Subjective Evaluations
A study testing Conventional nanohybrid multishade composite and Single shade nanohybrid composite in people with Composite Resins, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The ability of single-shade composite restorations to blend with adjacent tooth structure shades is called chameleon effect. This effect is enhanced using specially designed spherical particles in the composite material which will help diffuse light in a way that mimics the natural color and translucency of teeth… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Composite Resins
- What is being tested?
- Conventional nanohybrid multishade composite and Single shade nanohybrid composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 10 Mar 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients attending the dental clinics at JUST in Irbid or on the university campus.
- Patients aged 18 years and older.
- Patients with good oral hygiene.
- Patients with a positive attitude towards dental treatment.
- Patients require restorations on at least two anterior teeth.
- Patients with spaces between teeth that do not require orthodontic treatment for correction.
- Patients with healthy pulp or reversible pulpitis.
- Patients without any periapical lesions
Who cannot join
- Teeth with enamel or dentin deformations.
- Teeth affected by fluorosis or tetracycline staining.
- Teeth with severe discoloration.
- Primary teeth.
- Patients with gingival inflammation or periodontal disease.
- Patients undergoing active orthodontic treatment.
Show all 11Show fewer
- Heavy smokers.
- Very deep or very shallow cavities.
- Class IV cavities where more than half of the tooth surface is lost.
- Traumatic Class IV cavities with pulp exposure.
- Class III cavities that do not open labially.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, 21110
Zakereyya Albashaireh, PhD, 0791015505, albashai@just.edu.jo
About this study
Official title: Clinical and Subjective Evaluations of a Universal-Shade, Color Adjusting Resin Composite in Anterior Tooth Restorations: A Randomized Controlled Trial
The ability of single-shade composite restorations to blend with adjacent tooth structure shades is called chameleon effect. This effect is enhanced using specially designed spherical particles in the composite material which will help diffuse light in a way that mimics the natural color and translucency of teeth making the restoration nearly imperceptible to the naked eye.
The hypotheses of the investigation are as follow:
- Single-shade RBC exhibits similar shade matching and optical behavior to conventional RBC across all anterior restorations.
- Patient satisfaction regarding color blending between the restoration and tooth structure is comparable regardless of the type of material used.
- Dentist satisfaction regarding color blending is similar for both single-shade RBC and conventional RBC materials.
Read the detailed description
Optimal shade matching in restorative dentistry is crucial for achieving aesthetic success, particularly in anterior restorations. This study aims to evaluate the shade-matching efficacy of single-shade resin-based composites (RBCs) in comparison to conventional multi-shade composite, using spectrophotometric analysis as an objective measurement tool. Additionally, the study assesses patient and clinician satisfactions with the color adaptability of single-shade composites across various restoration types, including Class V, III, IV, and diastema closures.
A sample of 240 teeth will be selected based on strict inclusion criteria and divided into two groups: a test group receiving single-shade RBCs and a control group receiving multi-shade composite. Each patient will receive at least one restoration from each treatment group, ensuring balanced comparison within subjects. Satisfaction levels regarding color adaptability and aesthetic integration will be evaluated using a Visual Analogue Scale (VAS) one-week post-treatment. The double-blind design will be employed as it maintains blinding for both patients and evaluating clinicians regarding the materials used in each restoration.
- Conditions
- Composite Resins
- Being tested
- Conventional nanohybrid multishade composite, Single shade nanohybrid composite
- Keywords
- Single-sahde composite, Color adaptability,, Objective and subjective analysis, anterior restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional nanohybrid multishade compositeDrug
Also called Conventional resin based composite (RBC)
Teeth will be restored with conventional multi shade nanohybrid Resin Based Composite (RBC) filtek Z350Xt,3M ESPE, San Paul, MN, USA
Single shade nanohybrid compositeDrug
Also called RBC with color adjustment potential (CAP)
Teeth will be restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Control group (Conventional RBC) | Experimental | Group 1 (n=120) teeth will be restored using conventional multi shade nanohybrid RBC (filtek Z350Xt,3M ESPE, San Paul, MN, USA) Receives: Drug: Conventional nanohybrid multishade composite |
| Test group (RBC with CAP) | Experimental | Group 2 (n=120) teeth will be restored using Omnichroma (single shade) composite with color adjustment postential (CAP). (Omnichroma, Tokuyama Dental, Tokio, Japan) Receives: Drug: Single shade nanohybrid composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color measurements using digital spectrophotometer VITA Easyshade V.
The colour measurements will be taken at first session for each tooth in specific points as follow:
- One reading from middle part of tooth
- Three readings at three points around the restoration and 1 mm away from its margins.
- After one week and to give a chance for tooth rehydration and final color optimization a new reading will be obtained from the middle portion of the restoration.
The color difference(∆E00) between the tooth structure around the restoration and the restoration itself will be calculated.
The color difference(∆E00) between tooth and restoration will be compared between control and test group.
The final ΔE00 value itself has no physical unit-it is just a numerical representation of color difference.
Measured: 1 year
Subjective or Patient satisfaction
Patient satisfaction regarding the blending between the restoration and tooth surface will be recorded after one week using visual analogue scale (VAS).
The scale is a horizontal line having 10 digits. Digit 0 starting from the right indicates total dissatisfaction regarding color blending between tooth and restoration and digit 10 indicates complete satisfaction.
Patients will be asked to draw a line on VAS that represents their satisfaction regarding color matching and blending of the restoration.
Measurements will be divided according following criteria:
Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.
Measured: 1 year
Objective or dentists satisfaction
Photographs of the restored teeth will be taken under standard setup using Canon 250DSLR camera, Sigma 105 mm Macro lens and Meike MK-14EXT TTL Macro Ring Flash.
The pictures will be assessed by two calibrated dentists who did not know the restoration material being assessed. Blending with tooth surface will be done using VAS and the assessors will draw a line VAS.
Measurements will be divided according following criteria:
Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 Mar 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Composite ResinsStudies 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
- Split mouth study design, patients will be assigned to two different treatment protocols.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zakereyya SM Albashaireh, Ph.D, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884787
- Sponsor's protocol ID
- 20250094
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anwar RS, Hussein YF, Riad M. Optical behavior and marginal discoloration of a single shade resin composite with a chameleon effect: a randomized controlled clinical trial. BDJ Open. 2024 Feb 20;10(1):11. doi: 10.1038/s41405-024-00184-w.
PubMed 38378771Blum IR, Ozcan M. Reparative Dentistry: Possibilities and Limitations. Curr Oral Health Rep. 2018;5(4):264-269. doi: 10.1007/s40496-018-0191-1. Epub 2018 Sep 15.
PubMed 30524930Rashid F, Farook TH, Dudley J. Digital Shade Matching in Dentistry: A Systematic Review. Dent J (Basel). 2023 Oct 27;11(11):250. doi: 10.3390/dj11110250.
PubMed 37999014Barros MS, Silva PFD, Santana MLC, Braganca RMF, Faria-E-Silva AL. Background and surrounding colors affect the color blending of a single-shade composite. Braz Oral Res. 2023 Apr 28;37:e035. doi: 10.1590/1807-3107bor-2023.vol37.0035. eCollection 2023.
PubMed 37132724Leal CFC, Miranda SB, Alves Neto EL, Freitas K, de Sousa WV, Lins RBE, de Andrade AKM, Montes MAJR. Color Stability of Single-Shade Resin Composites in Direct Restorations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Polymers (Basel). 2024 Jul 30;16(15):2172. doi: 10.3390/polym16152172.
PubMed 39125196Ahmed MA, Jouhar R, Khurshid Z. Smart Monochromatic Composite: A Literature Review. Int J Dent. 2022 Nov 8;2022:2445394. doi: 10.1155/2022/2445394. eCollection 2022.
PubMed 36398065Korkut B, Turkmen C. Longevity of direct diastema closure and recontouring restorations with resin composites in maxillary anterior teeth: A 4-year clinical evaluation. J Esthet Restor Dent. 2021 Jun;33(4):590-604. doi: 10.1111/jerd.12697. Epub 2020 Dec 23.
PubMed 33354867Cubukcu I, Gundogdu I, Gul P. Color match analysis of single-shade and multi-shade composite resins using spectrophotometric and visual methods after bleaching. Dent Mater J. 2023 Nov 29;42(6):826-834. doi: 10.4012/dmj.2023-115. Epub 2023 Oct 12.
PubMed 37821366Cruz da Silva ET, Charamba Leal CF, Miranda SB, Evangelista Santos M, Saeger Meireles S, Maciel de Andrade AK, Japiassu Resende Montes MA. Evaluation of Single-Shade Composite Resin Color Matching on Extracted Human Teeth. ScientificWorldJournal. 2023 Jun 26;2023:4376545. doi: 10.1155/2023/4376545. eCollection 2023.
PubMed 37404241Rohym S, Tawfeek HEM, Kamh R. Effect of coffee on color stability and surface roughness of newly introduced single shade resin composite materials. BMC Oral Health. 2023 Apr 22;23(1):236. doi: 10.1186/s12903-023-02942-y.
PubMed 37087507Zulekha, Vinay C, Uloopi KS, RojaRamya KS, Penmatsa C, Ramesh MV. Clinical performance of one shade universal composite resin and nanohybrid composite resin as full coronal esthetic restorations in primary maxillary incisors: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2022 Apr-Jun;40(2):159-164. doi: 10.4103/jisppd.jisppd_151_22.
PubMed 35859408Miranda AO, Favoreto MW, Matos TP, Castro AS, Kunz P, Souza JL, Carvalho P, Reis A, Loguercio AD. Color Match of a Universal-shade Composite Resin for Restoration of Non-carious Cervical Lesions: An Equivalence Randomized Clinical Trial. Oper Dent. 2024 Jan 1;49(1):20-33. doi: 10.2341/23-021-C.
PubMed 38057996
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Subjective Evaluations of a Universal-Shade, Color Adjusting Resin Composite in Anterior Tooth Restorations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06884787
- Acronym / sponsor ID
- 20250094
- Conditions
- Composite Resins
- Keywords
- Single-sahde composite, Color adaptability,, Objective and subjective analysis, anterior restorations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Mar 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.
The ability of single-shade composite restorations to blend with adjacent tooth structure shades is called chameleon effect. This effect is enhanced using specially designed spherical particles in the composite material which will help diffuse light in a way that mimics the natural color and translucency of teeth making the restoration nearly imperceptible to the naked eye.
The hypotheses of the investigation are as follow:
- Single-shade RBC exhibits similar shade matching and optical behavior to conventional RBC across all anterior restorations.
- Patient satisfaction regarding color blending between the restoration and tooth structure is comparable regardless of the type of material used.
- Dentist satisfaction regarding color blending is similar for both single-shade RBC and conventional RBC materials.
Detailed description
Optimal shade matching in restorative dentistry is crucial for achieving aesthetic success, particularly in anterior restorations. This study aims to evaluate the shade-matching efficacy of single-shade resin-based composites (RBCs) in comparison to conventional multi-shade composite, using spectrophotometric analysis as an objective measurement tool. Additionally, the study assesses patient and clinician satisfactions with the color adaptability of single-shade composites across various restoration types, including Class V, III, IV, and diastema closures.
A sample of 240 teeth will be selected based on strict inclusion criteria and divided into two groups: a test group receiving single-shade RBCs and a control group receiving multi-shade composite. Each patient will receive at least one restoration from each treatment group, ensuring balanced comparison within subjects. Satisfaction levels regarding color adaptability and aesthetic integration will be evaluated using a Visual Analogue Scale (VAS) one-week post-treatment. The double-blind design will be employed as it maintains blinding for both patients and evaluating clinicians regarding the materials used in each restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth study design, patients will be assigned to two different treatment protocols.
| Arm | Type | Receives |
|---|---|---|
| Control group (Conventional RBC) | Experimental | Drug: Conventional nanohybrid multishade compositeGroup 1 (n=120) teeth will be restored using conventional multi shade nanohybrid RBC (filtek Z350Xt,3M ESPE, San Paul, MN, USA) |
| Test group (RBC with CAP) | Experimental | Drug: Single shade nanohybrid compositeGroup 2 (n=120) teeth will be restored using Omnichroma (single shade) composite with color adjustment postential (CAP). (Omnichroma, Tokuyama Dental, Tokio, Japan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients attending the dental clinics at JUST in Irbid or on the university campus.
- Patients aged 18 years and older.
- Patients with good oral hygiene.
- Patients with a positive attitude towards dental treatment.
- Patients require restorations on at least two anterior teeth.
Key exclusion criteria (11 listed)
- Teeth with enamel or dentin deformations.
- Teeth affected by fluorosis or tetracycline staining.
- Teeth with severe discoloration.
- Primary teeth.
- Patients with gingival inflammation or periodontal disease.
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 |
|---|---|---|
| Conventional nanohybrid multishade compositeAlso: Conventional resin based composite (RBC)Teeth will be restored with conventional multi shade nanohybrid Resin Based Composite (RBC) filtek Z350Xt,3M ESPE, San Paul, MN, USA | Drug | Control group (Conventional RBC) |
| Single shade nanohybrid compositeAlso: RBC with color adjustment potential (CAP)Teeth will be restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan) | Drug | Test group (RBC with CAP) |
Primary outcome
Color measurements using digital spectrophotometer VITA Easyshade V.
Time frame: 1 year
The colour measurements will be taken at first session for each tooth in specific points as follow: 1. One reading from middle part of tooth 2. Three readings at three points around the restoration and 1 mm away from its margins. 3. After one week and to give a chance for tooth rehydration and final color optimization a new reading will be obtained from the middle portion of the restoration. The color difference(∆E00) between the tooth structure around the restoration and the restoration itself will be calculated. The color difference(∆E00) between tooth and restoration will be compared between control and test group. The final ΔE00 value itself has no physical unit-it is just a numerical representation of color difference.
Subjective or Patient satisfaction
Time frame: 1 year
Patient satisfaction regarding the blending between the restoration and tooth surface will be recorded after one week using visual analogue scale (VAS). The scale is a horizontal line having 10 digits. Digit 0 starting from the right indicates total dissatisfaction regarding color blending between tooth and restoration and digit 10 indicates complete satisfaction. Patients will be asked to draw a line on VAS that represents their satisfaction regarding color matching and blending of the restoration. Measurements will be divided according following criteria: Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.
Objective or dentists satisfaction
Time frame: 1 year
Photographs of the restored teeth will be taken under standard setup using Canon 250DSLR camera, Sigma 105 mm Macro lens and Meike MK-14EXT TTL Macro Ring Flash. The pictures will be assessed by two calibrated dentists who did not know the restoration material being assessed. Blending with tooth surface will be done using VAS and the assessors will draw a line VAS. Measurements will be divided according following criteria: Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 38378771Anwar RS, Hussein YF, Riad M. Optical behavior and marginal discoloration of a single shade resin composite with a chameleon effect: a randomized controlled clinical trial. BDJ Open. 2024 Feb 20;10(1):11. doi: 10.1038/s41405-024-00184-w.
- Background: PubMed 30524930Blum IR, Ozcan M. Reparative Dentistry: Possibilities and Limitations. Curr Oral Health Rep. 2018;5(4):264-269. doi: 10.1007/s40496-018-0191-1. Epub 2018 Sep 15.
- Background: PubMed 37999014Rashid F, Farook TH, Dudley J. Digital Shade Matching in Dentistry: A Systematic Review. Dent J (Basel). 2023 Oct 27;11(11):250. doi: 10.3390/dj11110250.
- Background: PubMed 37132724Barros MS, Silva PFD, Santana MLC, Braganca RMF, Faria-E-Silva AL. Background and surrounding colors affect the color blending of a single-shade composite. Braz Oral Res. 2023 Apr 28;37:e035. doi: 10.1590/1807-3107bor-2023.vol37.0035. eCollection 2023.
- Background: PubMed 39125196Leal CFC, Miranda SB, Alves Neto EL, Freitas K, de Sousa WV, Lins RBE, de Andrade AKM, Montes MAJR. Color Stability of Single-Shade Resin Composites in Direct Restorations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Polymers (Basel). 2024 Jul 30;16(15):2172. doi: 10.3390/polym16152172.
- Background: PubMed 36398065Ahmed MA, Jouhar R, Khurshid Z. Smart Monochromatic Composite: A Literature Review. Int J Dent. 2022 Nov 8;2022:2445394. doi: 10.1155/2022/2445394. eCollection 2022.
- Background: PubMed 33354867Korkut B, Turkmen C. Longevity of direct diastema closure and recontouring restorations with resin composites in maxillary anterior teeth: A 4-year clinical evaluation. J Esthet Restor Dent. 2021 Jun;33(4):590-604. doi: 10.1111/jerd.12697. Epub 2020 Dec 23.
- Background: PubMed 37821366Cubukcu I, Gundogdu I, Gul P. Color match analysis of single-shade and multi-shade composite resins using spectrophotometric and visual methods after bleaching. Dent Mater J. 2023 Nov 29;42(6):826-834. doi: 10.4012/dmj.2023-115. Epub 2023 Oct 12.
- Background: PubMed 37404241Cruz da Silva ET, Charamba Leal CF, Miranda SB, Evangelista Santos M, Saeger Meireles S, Maciel de Andrade AK, Japiassu Resende Montes MA. Evaluation of Single-Shade Composite Resin Color Matching on Extracted Human Teeth. ScientificWorldJournal. 2023 Jun 26;2023:4376545. doi: 10.1155/2023/4376545. eCollection 2023.
- Background: PubMed 37087507Rohym S, Tawfeek HEM, Kamh R. Effect of coffee on color stability and surface roughness of newly introduced single shade resin composite materials. BMC Oral Health. 2023 Apr 22;23(1):236. doi: 10.1186/s12903-023-02942-y.
- Background: PubMed 35859408Zulekha, Vinay C, Uloopi KS, RojaRamya KS, Penmatsa C, Ramesh MV. Clinical performance of one shade universal composite resin and nanohybrid composite resin as full coronal esthetic restorations in primary maxillary incisors: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2022 Apr-Jun;40(2):159-164. doi: 10.4103/jisppd.jisppd_151_22.
- Background: PubMed 38057996Miranda AO, Favoreto MW, Matos TP, Castro AS, Kunz P, Souza JL, Carvalho P, Reis A, Loguercio AD. Color Match of a Universal-shade Composite Resin for Restoration of Non-carious Cervical Lesions: An Equivalence Randomized Clinical Trial. Oper Dent. 2024 Jan 1;49(1):20-33. doi: 10.2341/23-021-C.
- 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.
Zakereyya SM Albashaireh, Ph.D principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional nanohybrid multishade composite and Single shade nanohybrid composite in people with Composite Resins, run by King Abdullah University Hospital at 1 site in Jordan.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zakereyya SM Albashaireh, Ph.D (0791015505, albashai@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color measurements using digital spectrophotometer VITA Easyshade V. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884787, which also lists 12 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 19 Mar 2025.