Aligner StainingİnvisalignNCT05213650
Cleaning Agents Impact on Invisalign Aligners: A Cross-Over Randomized Trial
A study testing non-abrasive toothpaste, abrasive toothpaste and Efferdent in people with Aligner Staining, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Today, the increasing aesthetic expectations of the patients, showing its effect in the field of orthodontics, leads to the orientation towards aesthetic materials. The Invisalign system is also polyurethane for aesthetic purposes. It is a series of transparent plaques personalized to the patient's problems. Read more about this study
- Who is it for?
- Ages 7 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aligner Staining
- What is being tested?
- non-abrasive toothpaste, abrasive toothpaste and Efferdent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2021to 1 Dec 2022
- 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 7 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- No active periodontal disease
- No caries
- No systemic disease
- Patients who do not use any medication will be included in the study.
- Patients who will use more than 20 transparent plates in their treatment-
Who cannot join
- Smoking (more than 1 pack per day)
- Patients consuming dyes such as coffee, tea, beer and red wine more than 2 times a day
- Patients using less than 20 clear plates in their treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Cleaning Agents on Color and Roughness of Invisalign Clear Aligners: A Cross-Over Randomized Trial
Today, the increasing aesthetic expectations of the patients, showing its effect in the field of orthodontics, leads to the orientation towards aesthetic materials. The Invisalign system is also polyurethane for aesthetic purposes.
It is a series of transparent plaques personalized to the patient's problems. However, the transparent structure of the plaque increases the importance of its cleanliness.
Read more
There are many studies evaluating the removal of bacterial biofilm from plaques. However There are minimal studies evaluating the effect of the materials used for cleaning on the light transmittance, which has a significant effect on the aesthetics of the plaques.
The aim of this study is to compare 5 different agents' effects on colour change.
The work created will be divided into 5 groups according to the cleaning materials used.
One of the cleaning agents will be assigned by lot and will be used while the treatment processes are continuing.
The colour measurement will be carried out using the VITA Easyshade Compact spectrophotometer (VITA Zahnfabrik DEASYC220, Bad Sackingen, Germany). To prevent external light interference and keep the measurement head in a fixed position for each measurement, a special cubic box with a 3 mm radius entrance was created. The head of the device was firmly attached to the box lid with black tape to increase light-tightness. The colour measurement will be performed from the occlusal region of the second premolar tooth on the aligners, which will be placed on a standard white background. The colour measurement will be carried out as received and after the aligners were used in the patient's mouth for 2 weeks. Prior to measurements, the spectrophotometer will be calibrated according to the manufacturer's instructions. Each measurement will be repeated three times, and the average value will be determined. The Commision de l'Eclairage (CIE) Lab* system will be used for colour measurements. This system uses three parameters to define colour. The L* coordinate is a brightness measure that ranges from 0 (black) to 100 (white); the a* coordinate is horizontal and shows chromatic coordinates between red (+) and green (-), and the b* coordinate is also horizontal and extends in the direction of yellow (b+) and blue (b-). To determine the colour difference, a formula (Formula 1) will be used. ∆L, ∆a, and ∆b values will be calculated by subtracting the starting measurements (L0, a0, b0) from the final measurements (L1, a1, b1). The ∆E value will be calculated using these values, and the colour difference between groups will be compared.
∆E2-1 = [(∆L)2 + (+ (∆a)2 + (∆b)2]1/2= [(L1-L0)2 + (a1-a0)2 + (b1-b0)2]1/2 The formula proposed by Filho and da Silva will be used to convert ΔE values to National Bureau of Standards (NBS) values. NBS unit = ΔE* × 0.92. The ΔE values will be converted to their clinical significance using the NBS system.
According to the results of the research, the colour change of the agents used to clean Invisalign aligners will be determined.
The use of agents that have a minor effect on aesthetics can be considered ideal according to the results of the study
Read the detailed description
In recent years, following the developments in the field of orthodontics, the participation and expectations of patients in treatment have also changed. Conventional orthodontic brackets may cause aesthetic concerns in patients. The use of aesthetic materials and techniques aimed at overcoming such limitations has increased.
An orthodontic treatment system made with a material made of polyurethane was introduced for the first time in 1998 as an alternative to conventional brackets. This system uses CAD/CAM technology to produce serial plates personalized to the treatment process.
It is very important to clean these appliances for aesthetic reasons and to prevent bacteria from accumulating and becoming a focus of infection for the oral cavity. If plaques are not cleaned regularly, they can act as a reservoir for bacteria, leading to periodontal diseases, cavities and bad breath.
In the treatment of clear plaque, the patient is asked not to eat or drink anything other than water while the plaques are in the mouth. However, despite all the recommendations, patients sometimes do not comply with these and may consume coloring drinks while the plaques are in their mouths. This situation causes changes in the polymer of the material and adversely affects the aesthetics, which is the main advantage of clear aligner treatment.
Color stability of clear aligners remain critical considerations for both patients and clinicians. Despite the increasing cost, patients' desire for transparent aligners is due to the fact that these plates have almost no transparency in the mouth, so maintaining the original colour of the aligners is an important issue.
Although there are many studies in the literature evaluating the removal of bacterial biofilm after cleaning of clear plaques, there are very limited studies evaluating the Colour change of plaques.
In the light of this information, the aim of this research is to evaluate the colour change of transparent plaques, which is a polyurethane material, using 5 different cleaning methods. The cleaning methods to be used for this; toothpaste, whitening toothpaste, Corega Pro Guard \& Retainer cleaning tablet, Efferdent antibacterial cleaning tablet and liquid soap.
- Conditions
- Aligner Staining
- Being tested
- non-abrasive toothpaste, abrasive toothpaste, Efferdent, Cleaning Crystals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-abrasive toothpasteOther
Also called cleaning agent
Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Non-abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment.
abrasive toothpasteOther
Also called cleaning agent
Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment.
EfferdentOther
Also called cleaning agent
Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water.The Efferdent tablet will be used once a week as an intervention to aligner cleaning during invisalign treatment.
Cleaning CrystalsOther
Also called cleaning agent
Aligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Invisalign Cleaning Crystals will be used once a week as an intervention to aligner cleaning during invisalign treatment.
| Study group | Role | What they receive |
|---|---|---|
| Invisalign control patients (liquid soap) | No intervention | Patients who clean their plaques only with liquid soap and toothbrush |
| Invisalign non-abrasive toothpaste patients | Experimental | Patients who clean their plaque with non-abrasive toothpaste and toothbrush Receives: Other: non-abrasive toothpaste |
| Invisalign abrasive toothpaste patients | Experimental | Patients who clean their plaque with abrasive toothpaste and toothbrush Receives: Other: abrasive toothpaste |
| Invisalign Efferdent patients | Experimental | Patients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week Receives: Other: Efferdent |
| Invisalign Cleaning Crystals patients | Experimental | Patients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week Receives: Other: Cleaning Crystals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colour change (Delta E)_control
Delta E of 12 clear aligners of patients who clean their plaques only with liquid soap and a toothbrush
Measured: 2 week
Colour change (Delta E)_Invisalign non-abrasive toothpaste patients
Delta E of 12 clear aligners of patients who clean their plaques with non-abrasive toothpaste and toothbrush
Measured: 2 week
Colour change (Delta E)_ Invisalign abrasive toothpaste patients
lDelta E of 12 clear aligners of patients who clean their plaque with abrasive toothpaste and toothbrush
Measured: 2 week
Colour change (Delta E) Invisalign Efferdent patients
Delta E of 12 clear aligners of patients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week
Measured: 2 week
Colour change (Delta E) Invisalign Cleaning Crystals patients
Delta E of 12 clear aligners of patients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start18 Oct 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aligner StainingStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Kılıç, Bezmialem Vakif University
- Investigators
- Banu Kılıç, Study director, Bezmialem Vakıf Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213650
- Sponsor's protocol ID
- BezmialemVU invisalign
- Acronym
- İnvisalign
- Status last verified
- Jul 2023
- First submitted
- 17 Jan 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.
PubMed 30264270Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.
PubMed 19121497Kilic B, Canpolat S, Ozturk M. Comparative evaluation of the effect of different cleaning agents on colour and surface roughness of Invisalign clear aligners: a cross-over randomized controlled trial. BMC Oral Health. 2025 Nov 4;25(1):1745. doi: 10.1186/s12903-025-06928-w.
PubMed 41188779
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Cleaning Agents on Color and Roughness of Invisalign Clear Aligners: A Cross-Over Randomized Trial
- ClinicalTrials.gov ID
- NCT05213650
- Acronym / sponsor ID
- İnvisalign / BezmialemVU invisalign
- Conditions
- Aligner Staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Jan 2022 (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.
Today, the increasing aesthetic expectations of the patients, showing its effect in the field of orthodontics, leads to the orientation towards aesthetic materials. The Invisalign system is also polyurethane for aesthetic purposes.
It is a series of transparent plaques personalized to the patient's problems. However, the transparent structure of the plaque increases the importance of its cleanliness.
There are many studies evaluating the removal of bacterial biofilm from plaques. However There are minimal studies evaluating the effect of the materials used for cleaning on the light transmittance, which has a significant effect on the aesthetics of the plaques.
The aim of this study is to compare 5 different agents' effects on colour change.
The work created will be divided into 5 groups according to the cleaning materials used.
One of the cleaning agents will be assigned by lot and will be used while the treatment processes are continuing.
The colour measurement will be carried out using the VITA Easyshade Compact spectrophotometer (VITA Zahnfabrik DEASYC220, Bad Sackingen, Germany). To prevent external light interference and keep the measurement head in a fixed position for each measurement, a special cubic box with a 3 mm radius entrance was created. The head of the device was firmly attached to the box lid with black tape to increase light-tightness. The colour measurement will be performed from the occlusal region of the second premolar tooth on the aligners, which will be placed on a standard white background. The colour measurement will be carried out as received and after the aligners were used in the patient's mouth for 2 weeks. Prior to measurements, the spectrophotometer will be calibrated according to the manufacturer's instructions. Each measurement will be repeated three times, and the average value will be determined. The Commision de l'Eclairage (CIE) Lab* system will be used for colour measurements. This system uses three parameters to define colour. The L* coordinate is a brightness measure that ranges from 0 (black) to 100 (white); the a* coordinate is horizontal and shows chromatic coordinates between red (+) and green (-), and the b* coordinate is also horizontal and extends in the direction of yellow (b+) and blue (b-). To determine the colour difference, a formula (Formula 1) will be used. ∆L, ∆a, and ∆b values will be calculated by subtracting the starting measurements (L0, a0, b0) from the final measurements (L1, a1, b1). The ∆E value will be calculated using these values, and the colour difference between groups will be compared.
∆E2-1 = [(∆L)2 + (+ (∆a)2 + (∆b)2]1/2= [(L1-L0)2 + (a1-a0)2 + (b1-b0)2]1/2 The formula proposed by Filho and da Silva will be used to convert ΔE values to National Bureau of Standards (NBS) values. NBS unit = ΔE* × 0.92. The ΔE values will be converted to their clinical significance using the NBS system.
According to the results of the research, the colour change of the agents used to clean Invisalign aligners will be determined.
The use of agents that have a minor effect on aesthetics can be considered ideal according to the results of the study
Detailed description
In recent years, following the developments in the field of orthodontics, the participation and expectations of patients in treatment have also changed. Conventional orthodontic brackets may cause aesthetic concerns in patients. The use of aesthetic materials and techniques aimed at overcoming such limitations has increased.
An orthodontic treatment system made with a material made of polyurethane was introduced for the first time in 1998 as an alternative to conventional brackets. This system uses CAD/CAM technology to produce serial plates personalized to the treatment process.
It is very important to clean these appliances for aesthetic reasons and to prevent bacteria from accumulating and becoming a focus of infection for the oral cavity. If plaques are not cleaned regularly, they can act as a reservoir for bacteria, leading to periodontal diseases, cavities and bad breath.
In the treatment of clear plaque, the patient is asked not to eat or drink anything other than water while the plaques are in the mouth. However, despite all the recommendations, patients sometimes do not comply with these and may consume coloring drinks while the plaques are in their mouths. This situation causes changes in the polymer of the material and adversely affects the aesthetics, which is the main advantage of clear aligner treatment.
Color stability of clear aligners remain critical considerations for both patients and clinicians. Despite the increasing cost, patients' desire for transparent aligners is due to the fact that these plates have almost no transparency in the mouth, so maintaining the original colour of the aligners is an important issue.
Although there are many studies in the literature evaluating the removal of bacterial biofilm after cleaning of clear plaques, there are very limited studies evaluating the Colour change of plaques.
In the light of this information, the aim of this research is to evaluate the colour change of transparent plaques, which is a polyurethane material, using 5 different cleaning methods. The cleaning methods to be used for this; toothpaste, whitening toothpaste, Corega Pro Guard \& Retainer cleaning tablet, Efferdent antibacterial cleaning tablet and liquid soap.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Invisalign control patients (liquid soap) | No intervention | –Patients who clean their plaques only with liquid soap and toothbrush |
| Invisalign non-abrasive toothpaste patients | Experimental | Other: non-abrasive toothpastePatients who clean their plaque with non-abrasive toothpaste and toothbrush |
| Invisalign abrasive toothpaste patients | Experimental | Other: abrasive toothpastePatients who clean their plaque with abrasive toothpaste and toothbrush |
| Invisalign Efferdent patients | Experimental | Other: EfferdentPatients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week |
| Invisalign Cleaning Crystals patients | Experimental | Other: Cleaning CrystalsPatients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (3 listed)
- Smoking (more than 1 pack per day)
- Patients consuming dyes such as coffee, tea, beer and red wine more than 2 times a day
- Patients using less than 20 clear plates in their treatment
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 |
|---|---|---|
| non-abrasive toothpasteAlso: cleaning agentAligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Non-abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment. | Other | Invisalign non-abrasive toothpaste patients |
| abrasive toothpasteAlso: cleaning agentAligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Abrasive toothpaste will be used as intervention to aligner cleaning during invisalign treatment. | Other | Invisalign abrasive toothpaste patients |
| EfferdentAlso: cleaning agentAligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water.The Efferdent tablet will be used once a week as an intervention to aligner cleaning during invisalign treatment. | Other | Invisalign Efferdent patients |
| Cleaning CrystalsAlso: cleaning agentAligners should be cleaned at least once a day, but twice is preferred to prevent them from changing color or having a bad odor. They should be treated just like teeth and cleaned often, especially after eating and drinking.Usually, dentists advise their patients to clean their plaques with only liquid soap, toothbrush and water. Invisalign Cleaning Crystals will be used once a week as an intervention to aligner cleaning during invisalign treatment. | Other | Invisalign Cleaning Crystals patients |
Primary outcome
Colour change (Delta E)_control
Time frame: 2 week
Delta E of 12 clear aligners of patients who clean their plaques only with liquid soap and a toothbrush
Colour change (Delta E)_Invisalign non-abrasive toothpaste patients
Time frame: 2 week
Delta E of 12 clear aligners of patients who clean their plaques with non-abrasive toothpaste and toothbrush
Colour change (Delta E)_ Invisalign abrasive toothpaste patients
Time frame: 2 week
lDelta E of 12 clear aligners of patients who clean their plaque with abrasive toothpaste and toothbrush
Colour change (Delta E) Invisalign Efferdent patients
Time frame: 2 week
Delta E of 12 clear aligners of patients who clean their plaques with liquid soap and use Efferdent antibacterial cleaning tablet once a week
Colour change (Delta E) Invisalign Cleaning Crystals patients
Time frame: 2 week
Delta E of 12 clear aligners of patients who clean their plaques with liquid soap and use Invisalign Cleaning Crystals tablet once a week
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 27 Jul 2023.
- Background: PubMed 30264270Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.
- Background: PubMed 19121497Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.
- Derived from this study: PubMed 41188779Kilic B, Canpolat S, Ozturk M. Comparative evaluation of the effect of different cleaning agents on colour and surface roughness of Invisalign clear aligners: a cross-over randomized controlled trial. BMC Oral Health. 2025 Nov 4;25(1):1745. doi: 10.1186/s12903-025-06928-w.
- Individual participant dataSharing planned: No
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.
Banu Kılıç study director
Bezmialem Vakıf Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-abrasive toothpaste, abrasive toothpaste and Efferdent in people with Aligner Staining, run by Bezmialem Vakif University 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 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. 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?
Colour change (Delta E)_control (time frame: 2 week). The study lists 5 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 NCT05213650, which also lists 3 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 27 Jul 2023.