Composites ResinsNCT06299150
Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children
A study testing IPS e.max CAD in people with Composites Resins, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
Dental trauma (DT) of the incisors and their supporting tissues, one of the most challenging dental emergencies, requires immediate assessment and management due to psychological and physical reasons. This is especially important for young permanent teeth to minimize undesired complications. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Composites Resins
- What is being tested?
- IPS e.max CAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 8-18 years old
- Ellis Class II traumatized central incisors
- Controlled dental disease - no active caries or periodontal diseases
- Patients will be available to be clinically reviewed up to 1 year
Who cannot join
- All Ellis Classification traumatized central incisors except Ellis Class II
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
- Poor oral hygiene and motivation.
- Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
- Patients with debilitating illnesses or complicating medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children: Randomized Clinical Trial
Dental trauma (DT) of the incisors and their supporting tissues, one of the most challenging dental emergencies, requires immediate assessment and management due to psychological and physical reasons. This is especially important for young permanent teeth to minimize undesired complications. The treatment of dental trauma is sometimes neglected, although it might lead to pain, difficulty in articulation and mastication, and considerable negative effects on a patient's self-esteem. However, the aesthetics of the anterior teeth are very important aspects of human appearance and can be affected by many factors, including the presence of fillings, tooth color, position, alignment, shape, and number.
Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19.
Read more
As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic, and time-efficient restoration is frequently demanded. According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment. As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color, and function in a minimum amount of time. Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies.
In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments has become increasingly popular over the last few years. PLVs are thin pieces of glass matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies and case reports, without any clinical information available at present.
Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment, or partial laminate veneers) that require minimal to no preparation and do not require local anesthesia.
Read the detailed description
Aim of the study:
This randomized clinical trial study will assess the survival and success rates of three different types of conservative restorations restored the Ellis Class II traumatized central incisors by clinical evaluation of the patients.
Research question:
Are the direct resin composite mini-veneer, reattachment of broken segments and IPS e.max CAD clinically successful techniques in restoring Ellis Class II traumatized central incisors in children?
PICOS:
P: Patients above 8 years old with traumatized upper incisor I (1): Partial laminate veneers (PLV) I (2): Fragment reattachment C: Conventional composite restoration O: Clinical Success S: In-Vivo Study
II. Methods
Study Design:
Study Type: Interventional (Clinical Trial) Estimated Enrolment: 40 participants Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Official Title: Clinical Evaluation of Three Different Techniques restoring
Ellis Class II traumatized central incisors in children:
Randomized Clinical Trial Estimated Study Start Date: December 2023 Estimated Primary Completion Date: January 2024
Trial design:
The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded.
Outcome Measures:
- Primary outcome: Clinical success/ survival [Time Frame: 12 months].
- Clinical success will evaluate using (a modified version of the United States Public Health Service (USPHS) criteria). [Appendix A]
- Each parameter will assess using visual and tactile observations (probe and mirror).
- At the checkup visits (3, 6, 9, 12 months), will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician.
- The need for replacement and partial fractures (chippings) will define as failures
- Secondary outcomes: [Time Frame: 12 months].
- Marginal adaptation: using Trios 3 scanner via scan compare (microns)
- Colour change: using Trios 3 scanner via scan compare (yes or no binary)
- Patient centred outcomes to the restoration: Patient's satisfaction questioner. (33) [Appendix B] Eligibility Criteria
Ages Eligible for Study: 8 - 18 Years Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
- 8-18 years old
- Ellis Class II traumatized central incisors
- Controlled dental disease - no active caries or periodontal diseases
- Patients will be available to be clinically reviewed up to 1 year
Exclusion Criteria:
- All Ellis Classification traumatized central incisors except Ellis Class II
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
- Poor oral hygiene and motivation.
- Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
- Patients with debilitating illnesses or complicating medical conditions
Explanation for choice of comparators:
Composites resins have become the first choice for direct anterior and posterior restorations. The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments. Several studies have demonstrated that composite restorations may last long in clinical service. Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1% to 3% in posterior teeth and 1% to 5% in anterior teeth. (34)
Thus, direct resin composites offer several advantages to both patients and clinicians, including a reduction in treatment costs and clinical working times (i.e., fewer clinical appointments), as well as reversibility and reparability of the treatment. For these reasons, most clinicians consider resin composites as the material of choice when maximum preservation of the tooth structure is required. (24,35)
Sample size (Power analysis):
Sample size calculated depending on a previous study (Oosterhaven et al., 2023) as reference. (24) According to this study, the probability of color match (clinical success) in group 1 is 0.98. If the estimated probability of group 2 is 0.6, we will need to study 17 cases in each group with probability (power) 0.8. The Type I error probability. Total sample size increased to 20 subjects per group to compensate for a 15 % drop out during follow up. Sample size calculation was achieved using chi-squared test to evaluate that was performed by using P.S. Power3.1.6, software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA.
Statistical Methods
Statistical analysis:
Data were collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. And Minitab ® statistical software Ver. 16.
Handling of numerical / quantitative variables:
Numerical data will be explored for normality by checking the data distribution using Kolmogorov- Smirnov and Shapiro-Wilk tests. Data will be presented as mean \& standard deviation. If data will be normally distributed comparison between 2 different groups will be performed by using independent t-test, comparison between 2 related groups will be performed by using Paired t-test, while comparison between more than 2 groups will be performed by using One Way ANOVA test followed by Tukey's Post Hoc test for multiple comparisons. If data will be non-parametric data comparison between 2 different groups will be performed by using Mann-Whitney test, comparison between 2 related groups will be performed by using Wilcoxon Signed Rank test, while comparison between more than 2 groups will be performed by using Kruskal-Walli's test.
Handling of categorial / qualitative variables:
Data will be presented as frequency and percentages. All comparisons will be performed by using Chi square test.
Recruitment:
The study will be conducted at the pediatric dentistry department of MSA University pediatric outpatients. All subjects will be monitored and reviewed every 3 months for 12 months.
Post-trial care
- Oral hygiene instructions and serving brush and toothpaste
- Dietary recommendations
- Conditions
- Composites Resins
- Being tested
- IPS e.max CAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPS e.max CADOther
CAD CAM Restoration
| Study group | Role | What they receive |
|---|---|---|
| direct resin composite mini-veneer | Active comparator | Composites resins have become the first choice for direct anterior and posterior restorations. The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments. Several studies have demonstrated that composite restorations may last long in clinical service. Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1% to 3% in posterior teeth and 1% to 5% in anterior teeth. Receives: Other: IPS e.max CAD |
| IPS e.max CAD | Experimental | "IPS e max" likely refers to a type of dental material or technology. IPS e.max is a popular brand of lithium disilicate glass-ceramic used in dentistry for the fabrication of dental restorations such as crowns, veneers, inlays, onlays, and bridges.
IPS e.max restorations are known for their excellent esthetics, strength, and durability. They are designed to closely mimic the natural appearance of teeth while providing reliable performance and longevity. Dentists often choose IPS e.max restorations for their patients due to their versatility and ability to meet both esthetic and functional requirements. Receives: Other: IPS e.max CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success/ survival
- Clinical success will evaluate using (a modified version of the United States Public Health Service (USPHS) criteria). [Appendix A]
- Each parameter will assess using visual and tactile observations (probe and mirror).
- At the checkup visits (3, 6, 9, 12 months), will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician.
- The need for replacement and partial fractures (chippings) will define as failures
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Composites 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
- The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Salmoon, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299150
- Sponsor's protocol ID
- 2023-1
- Status last verified
- Dec 2024
- First submitted
- 23 Feb 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06299150
- Acronym / sponsor ID
- 2023-1
- Conditions
- Composites Resins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 7 Mar 2024 (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.
Dental trauma (DT) of the incisors and their supporting tissues, one of the most challenging dental emergencies, requires immediate assessment and management due to psychological and physical reasons. This is especially important for young permanent teeth to minimize undesired complications. The treatment of dental trauma is sometimes neglected, although it might lead to pain, difficulty in articulation and mastication, and considerable negative effects on a patient's self-esteem. However, the aesthetics of the anterior teeth are very important aspects of human appearance and can be affected by many factors, including the presence of fillings, tooth color, position, alignment, shape, and number.
Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19.
As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic, and time-efficient restoration is frequently demanded. According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment. As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color, and function in a minimum amount of time. Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies.
In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments has become increasingly popular over the last few years. PLVs are thin pieces of glass matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies and case reports, without any clinical information available at present.
Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment, or partial laminate veneers) that require minimal to no preparation and do not require local anesthesia.
Detailed description
Aim of the study:
This randomized clinical trial study will assess the survival and success rates of three different types of conservative restorations restored the Ellis Class II traumatized central incisors by clinical evaluation of the patients.
Research question:
Are the direct resin composite mini-veneer, reattachment of broken segments and IPS e.max CAD clinically successful techniques in restoring Ellis Class II traumatized central incisors in children?
PICOS:
P: Patients above 8 years old with traumatized upper incisor I (1): Partial laminate veneers (PLV) I (2): Fragment reattachment C: Conventional composite restoration O: Clinical Success S: In-Vivo Study
II. Methods
Study Design:
Study Type: Interventional (Clinical Trial) Estimated Enrolment: 40 participants Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Official Title: Clinical Evaluation of Three Different Techniques restoring
Ellis Class II traumatized central incisors in children:
Randomized Clinical Trial Estimated Study Start Date: December 2023 Estimated Primary Completion Date: January 2024
Trial design:
The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded.
Outcome Measures:
- Primary outcome: Clinical success/ survival [Time Frame: 12 months].
- Clinical success will evaluate using (a modified version of the United States Public Health Service (USPHS) criteria). [Appendix A]
- Each parameter will assess using visual and tactile observations (probe and mirror).
- At the checkup visits (3, 6, 9, 12 months), will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician.
- The need for replacement and partial fractures (chippings) will define as failures
- Secondary outcomes: [Time Frame: 12 months].
- Marginal adaptation: using Trios 3 scanner via scan compare (microns)
- Colour change: using Trios 3 scanner via scan compare (yes or no binary)
- Patient centred outcomes to the restoration: Patient's satisfaction questioner. (33) [Appendix B] Eligibility Criteria
Ages Eligible for Study: 8 - 18 Years Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
- 8-18 years old
- Ellis Class II traumatized central incisors
- Controlled dental disease - no active caries or periodontal diseases
- Patients will be available to be clinically reviewed up to 1 year
Exclusion Criteria:
- All Ellis Classification traumatized central incisors except Ellis Class II
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
- Poor oral hygiene and motivation.
- Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
- Patients with debilitating illnesses or complicating medical conditions
Explanation for choice of comparators:
Composites resins have become the first choice for direct anterior and posterior restorations. The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments. Several studies have demonstrated that composite restorations may last long in clinical service. Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1% to 3% in posterior teeth and 1% to 5% in anterior teeth. (34)
Thus, direct resin composites offer several advantages to both patients and clinicians, including a reduction in treatment costs and clinical working times (i.e., fewer clinical appointments), as well as reversibility and reparability of the treatment. For these reasons, most clinicians consider resin composites as the material of choice when maximum preservation of the tooth structure is required. (24,35)
Sample size (Power analysis):
Sample size calculated depending on a previous study (Oosterhaven et al., 2023) as reference. (24) According to this study, the probability of color match (clinical success) in group 1 is 0.98. If the estimated probability of group 2 is 0.6, we will need to study 17 cases in each group with probability (power) 0.8. The Type I error probability. Total sample size increased to 20 subjects per group to compensate for a 15 % drop out during follow up. Sample size calculation was achieved using chi-squared test to evaluate that was performed by using P.S. Power3.1.6, software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA.
Statistical Methods
Statistical analysis:
Data were collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. And Minitab ® statistical software Ver. 16.
Handling of numerical / quantitative variables:
Numerical data will be explored for normality by checking the data distribution using Kolmogorov- Smirnov and Shapiro-Wilk tests. Data will be presented as mean \& standard deviation. If data will be normally distributed comparison between 2 different groups will be performed by using independent t-test, comparison between 2 related groups will be performed by using Paired t-test, while comparison between more than 2 groups will be performed by using One Way ANOVA test followed by Tukey's Post Hoc test for multiple comparisons. If data will be non-parametric data comparison between 2 different groups will be performed by using Mann-Whitney test, comparison between 2 related groups will be performed by using Wilcoxon Signed Rank test, while comparison between more than 2 groups will be performed by using Kruskal-Walli's test.
Handling of categorial / qualitative variables:
Data will be presented as frequency and percentages. All comparisons will be performed by using Chi square test.
Recruitment:
The study will be conducted at the pediatric dentistry department of MSA University pediatric outpatients. All subjects will be monitored and reviewed every 3 months for 12 months.
Post-trial care
- Oral hygiene instructions and serving brush and toothpaste
- Dietary recommendations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a randomized clinical trial (RCT) where 2 arm parallel groups with a 1:1 allocation ratio were compared. The child participants and the legal guardian of each participating child and the statistician were blinded.
| Arm | Type | Receives |
|---|---|---|
| direct resin composite mini-veneer | Active comparator | Other: IPS e.max CADComposites resins have become the first choice for direct anterior and posterior restorations. The great popularity is related to their esthetic appearance and reduced need of sound tissue removal as compared with former treatments. Several studies have demonstrated that composite restorations may last long in clinical service. Composite restorations have demonstrated a good clinical performance with annual failure rates varying from 1% to 3% in posterior teeth and 1% to 5% in anterior teeth. |
| IPS e.max CAD | Experimental | Other: IPS e.max CAD"IPS e max" likely refers to a type of dental material or technology. IPS e.max is a popular brand of lithium disilicate glass-ceramic used in dentistry for the fabrication of dental restorations such as crowns, veneers, inlays, onlays, and bridges. IPS e.max restorations are known for their excellent esthetics, strength, and durability. They are designed to closely mimic the natural appearance of teeth while providing reliable performance and longevity. Dentists often choose IPS e.max restorations for their patients due to their versatility and ability to meet both esthetic and functional requirements. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 8-18 years old
- Ellis Class II traumatized central incisors
- Controlled dental disease - no active caries or periodontal diseases
- Patients will be available to be clinically reviewed up to 1 year
Key exclusion criteria (5 listed)
- All Ellis Classification traumatized central incisors except Ellis Class II
- Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
- Poor oral hygiene and motivation.
- Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
- Patients with debilitating illnesses or complicating medical conditions
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 |
|---|---|---|
| IPS e.max CADCAD CAM Restoration | Other | IPS e.max CAD, direct resin composite mini-veneer |
Primary outcome
Clinical success/ survival
Time frame: 12 months
* Clinical success will evaluate using (a modified version of the United States Public Health Service (USPHS) criteria). [Appendix A] * Each parameter will assess using visual and tactile observations (probe and mirror). * At the checkup visits (3, 6, 9, 12 months), will take standardized photographs and the restorations will clinically evaluate by an independent and calibrated clinician. * The need for replacement and partial fractures (chippings) will define as failures
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 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPS e.max CAD in people with Composites Resins, run by October University for Modern Sciences and Arts at 1 site in Egypt.
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 4 inclusion and 5 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 Dec 2024. 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 Egypt. 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 success/ survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.