Dentin HypersensitivityPhase 2/3NCT04804423
Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth
A Phase 2/3 study testing 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®) and Sodium fluoride varnish (generic name; Duraphat®) in people with Dentin Hypersensitivity and Active Dental Caries, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This observational cohort study aims to evaluate the short-term (3 months) efficacy of the standard fluoride therapy in the German National Health System for managing hypersensitive carious lesions in primary teeth (fluoride varnish application), and further compare it to a different fluoride therapy utilizing a… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Dentin Hypersensitivity, Active Dental Caries
- What is being tested?
- 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®) and Sodium fluoride varnish (generic name; Duraphat®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jan 2020to 1 Apr 2021
- Phase
- Phase 2/3
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Reported hypersensitivity in primary teeth associated with the presence of active carious lesions (ICDAS 5).
- Healthy children aged 2-5 years.
- Not using any desensitizer for 1-month prior the study.
- Willing to be examined.
Who cannot join
- Previously restored teeth.
- Teeth with signs or symptoms of irreversible pulpitis.
- Patients with any systemic disease requiring special considerations during their dental treatment.
- Parents/children who declined to participate in the study.
Trial locations and contacts
1 site in 1 country.
Germany1 site
The Department of Preventive and Pediatric Dentistry, University of Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: Evaluation of the Efficacy of Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth
This observational cohort study aims to evaluate the short-term (3 months) efficacy of the standard fluoride therapy in the German National Health System for managing hypersensitive carious lesions in primary teeth (fluoride varnish application), and further compare it to a different fluoride therapy utilizing a silver-containing fluoride agent combined with potassium iodide solution.
Read the detailed description
A single trained investigator will screen for possible study participants of children aged 2-5 years old, and their parents will be asked to participate in the study. The participants will be consecutively recruited from regular clinic attendees of the Department of Preventive and Pediatric Dentistry at the University of Greifswald, from whom present with active carious lesions (ICDAS 5) along symptoms of hypersensitivity to be treated with fluoride varnish, and further compared to participants treated with silver fluoride and potassium iodide application.
Eligibility to the study will be determined by a single trained examiner through clinical findings of caries activity according to Bjørndal criteria, and reported history of hypersensitivity symptoms obtained from the parent/caregiver of the participant, followed by hypersensitivity confirmatory test using a triple syringe air blast on the exposed surface of the carious lesion to allocate areas with suspected dentin hypersensitivity.
After clinical examination and obtainment of an informed consent, eligible children will be treated with fluoride varnish application (Duraphat®), or silver fluoride and potassium iodide application (Riva Star®) according to manufacturer's instructions.The participant's behavior shall be evaluated at the beginning, during and after treatment. Plaque Index (API) and Papillary Bleeding Index (PBI) will also be assessed prior to treatment and at the 3-months mark. Procedures will be performed by six different dentists (four pediatric specialists and two post-graduate pediatric dentistry students), all of whom were briefed on the study protocol and received instructions in carrying in the interventions according to the manufacturer's guide, and their technical opinions regarding the performed procedures will be obtained following the procedure. Follow up examinations after 3 months will be done by a single examiner. Only one tooth per child will be included in the analysis.
Data and information of this study will be recorded, handled, and stored in an organized and secure way, to allow its accurate reporting, interpretation, and verification. To assure confidentiality of clinical records, an unambiguous subject identification code will be used. Patients who are no longer willing to continue in the study will have the right to quit at any time without any penalty.
All variables will be statistically analyzed using descriptive statistics, plots, and tests of normality. Means and standard deviations (SD) will be calculated for all quantitative variables, while frequencies and percentages will be calculated for categorical variables.
Comparison between the two study groups will utilize independent samples t-test for quantitative normally distributed variables, and Mann-Whitney U for quantitative non-normally distributed variables and qualitative ordinal variables. Chi-squared and Fisher exact tests will be performed for comparing qualitative nominal variables between the two study groups. Comparing the baseline and follow-up shall be done using paired t-test when the variable is normally distributed, and Wilcoxon signed rank test when the variable is not normally distributed. For comparing lesion activity before and after treatment, McNemar test will be used and Friedman test for comparing the children's behavior at 3 different time points (before, during and after treatment).
A Significance will be set at p<0.05. Data will be analyzed using IBM SPSS statistical software for windows (version 25).
- Conditions
- Dentin Hypersensitivity, Active Dental Caries
- Being tested
- 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®), Sodium fluoride varnish (generic name; Duraphat®)
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)Drug
Also called Riva Star®
38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions.
Sodium fluoride varnish (generic name; Duraphat®)Drug
Also called Duraphat®
22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride varnish (Duraphat®) | Active comparator | Fluoride varnish application is recommended by the German National Health System for managing hypersensitivity and dental caries. Sodium fluoride varnish (Duraphat®) will be applied on hypersensitive active carious lesions (ICDAS 5). Receives: Drug: Sodium fluoride varnish (generic name; Duraphat®) |
| Silver fluoride and potassium iodide (Riva Star®) | Experimental | Silver fluoride and potassium iodide (Riva Star®) is primarily indicated for relieving hypersensitivity will be applied on hypersensitive active carious lesions (ICDAS 5) following isolation of the affected teeth and according to manufacturer's instructions. Receives: Drug: 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity pain relief
The degree of pain severity will be quantified by a visual analogue scale - VAS; 0-10, ranging across a continuum from none (0) to a severe amount of pain (10).
Measured: 3 Months
Secondary outcomes (3)
Activity of carious lesions
Lesions will be assessed for caries activity using visual tactile criteria (Bjørndal Criteria; 0 - 9= sound -missing tooth) 0. Sound
- Active lesion in enamel , without cavity ( bright surface with brown discoloration )
- Active cavity in enamel ( opaque enamel surface and loss of substance )
- Active cavity in enamel ( bright surface , brown discoloration, wet dentin )
- Inactive cavity in enamel ( bright surface, brown discoloration and loss of substance )
- Active cavity in enamel/dentin ( yellow or light brown discoloration , wet dentin )
- Inactive cavity in enamel/dentin ( dark brown discoloration, hard and dry dentin )
- Pulpal involvement or root stumps
- Filled tooth
- Missing tooth
Measured: 3 Months
Patient Acceptance
Children's behavior before, during and after treatment was assessed using Frankl's Scale
- Definitely positive: Good rapport with the dentist, interested in the dental procedure, laughing and enjoying the situation
- Positive: Acceptance of treatment; at time cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively
- Negative: Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced
- Definitely negative: Refusal of treatment, crying forcefully, fearful, or any other overt evidence of extreme negativism
Measured: Only at baseline (begining, during and after procedure)
Operating Dentists' Opinion About the Procedure Performed
Dentist's technical opinion regarding the procedures and materials used in the study groups will be collected directly after performing the procedure using 5-point Likert scales.
Measured: Will be recorded immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start13 Jan 2020
- Primary completion31 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- SDI Limited
- Responsible party
- Sponsor
- Investigators
- Mohamed H Abudrya, BDS, MSc., Principal investigator, The Department of Preventive and Pediatric Dentistry, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804423
- Sponsor's protocol ID
- ID-KinderZZMK-2020
- Status last verified
- May 2021
- First submitted
- 4 Mar 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.
PubMed 24993261Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.
PubMed 28457477Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2018 Oct 15;40(6):152-161.
PubMed 32074885Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
PubMed 26831727Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of Dental Caries and Dental Caries Management: Consensus Report of a Workshop Organized by ORCA and Cariology Research Group of IADR. Caries Res. 2020;54(1):7-14. doi: 10.1159/000503309. Epub 2019 Oct 7.
PubMed 31590168Poulsen S, Errboe M, Hovgaard O, Worthington HW. Potassium nitrate toothpaste for dentine hypersensitivity. Cochrane Database Syst Rev. 2001;(2):CD001476. doi: 10.1002/14651858.CD001476.
PubMed 11405992Splieth CH, Tachou A. Epidemiology of dentin hypersensitivity. Clin Oral Investig. 2013 Mar;17 Suppl 1(Suppl 1):S3-8. doi: 10.1007/s00784-012-0889-8. Epub 2012 Dec 7.
PubMed 23224064Santamaria RM, Innes NPT, Machiulskiene V, Schmoeckel J, Alkilzy M, Splieth CH. Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial. Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.
PubMed 29258064Santamaria RM, Abudrya MH, Gul G, Mourad MS, Gomez GF, Zandona AGF. How to Intervene in the Caries Process: Dentin Caries in Primary Teeth. Caries Res. 2020;54(4):306-323. doi: 10.1159/000508899. Epub 2020 Aug 27.
PubMed 32854105
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth
- ClinicalTrials.gov ID
- NCT04804423
- Acronym / sponsor ID
- ID-KinderZZMK-2020
- Conditions
- Dentin Hypersensitivity, Active Dental Caries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- SDI Limited
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 18 Mar 2021 (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 observational cohort study aims to evaluate the short-term (3 months) efficacy of the standard fluoride therapy in the German National Health System for managing hypersensitive carious lesions in primary teeth (fluoride varnish application), and further compare it to a different fluoride therapy utilizing a silver-containing fluoride agent combined with potassium iodide solution.
Detailed description
A single trained investigator will screen for possible study participants of children aged 2-5 years old, and their parents will be asked to participate in the study. The participants will be consecutively recruited from regular clinic attendees of the Department of Preventive and Pediatric Dentistry at the University of Greifswald, from whom present with active carious lesions (ICDAS 5) along symptoms of hypersensitivity to be treated with fluoride varnish, and further compared to participants treated with silver fluoride and potassium iodide application.
Eligibility to the study will be determined by a single trained examiner through clinical findings of caries activity according to Bjørndal criteria, and reported history of hypersensitivity symptoms obtained from the parent/caregiver of the participant, followed by hypersensitivity confirmatory test using a triple syringe air blast on the exposed surface of the carious lesion to allocate areas with suspected dentin hypersensitivity.
After clinical examination and obtainment of an informed consent, eligible children will be treated with fluoride varnish application (Duraphat®), or silver fluoride and potassium iodide application (Riva Star®) according to manufacturer's instructions.The participant's behavior shall be evaluated at the beginning, during and after treatment. Plaque Index (API) and Papillary Bleeding Index (PBI) will also be assessed prior to treatment and at the 3-months mark. Procedures will be performed by six different dentists (four pediatric specialists and two post-graduate pediatric dentistry students), all of whom were briefed on the study protocol and received instructions in carrying in the interventions according to the manufacturer's guide, and their technical opinions regarding the performed procedures will be obtained following the procedure. Follow up examinations after 3 months will be done by a single examiner. Only one tooth per child will be included in the analysis.
Data and information of this study will be recorded, handled, and stored in an organized and secure way, to allow its accurate reporting, interpretation, and verification. To assure confidentiality of clinical records, an unambiguous subject identification code will be used. Patients who are no longer willing to continue in the study will have the right to quit at any time without any penalty.
All variables will be statistically analyzed using descriptive statistics, plots, and tests of normality. Means and standard deviations (SD) will be calculated for all quantitative variables, while frequencies and percentages will be calculated for categorical variables.
Comparison between the two study groups will utilize independent samples t-test for quantitative normally distributed variables, and Mann-Whitney U for quantitative non-normally distributed variables and qualitative ordinal variables. Chi-squared and Fisher exact tests will be performed for comparing qualitative nominal variables between the two study groups. Comparing the baseline and follow-up shall be done using paired t-test when the variable is normally distributed, and Wilcoxon signed rank test when the variable is not normally distributed. For comparing lesion activity before and after treatment, McNemar test will be used and Friedman test for comparing the children's behavior at 3 different time points (before, during and after treatment).
A Significance will be set at p<0.05. Data will be analyzed using IBM SPSS statistical software for windows (version 25).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride varnish (Duraphat®) | Active comparator | Drug: Sodium fluoride varnish (generic name; Duraphat®)Fluoride varnish application is recommended by the German National Health System for managing hypersensitivity and dental caries. Sodium fluoride varnish (Duraphat®) will be applied on hypersensitive active carious lesions (ICDAS 5). |
| Silver fluoride and potassium iodide (Riva Star®) | Experimental | Drug: 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)Silver fluoride and potassium iodide (Riva Star®) is primarily indicated for relieving hypersensitivity will be applied on hypersensitive active carious lesions (ICDAS 5) following isolation of the affected teeth and according to manufacturer's instructions. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Reported hypersensitivity in primary teeth associated with the presence of active carious lesions (ICDAS 5).
- Healthy children aged 2-5 years.
- Not using any desensitizer for 1-month prior the study.
- Willing to be examined.
Key exclusion criteria (4 listed)
- Previously restored teeth.
- Teeth with signs or symptoms of irreversible pulpitis.
- Patients with any systemic disease requiring special considerations during their dental treatment.
- Parents/children who declined to participate in the study.
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 |
|---|---|---|
| 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)Also: Riva Star®38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions. | Drug | Silver fluoride and potassium iodide (Riva Star®) |
| Sodium fluoride varnish (generic name; Duraphat®)Also: Duraphat®22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions. | Drug | Fluoride varnish (Duraphat®) |
Primary outcome
Hypersensitivity pain relief
Time frame: 3 Months
The degree of pain severity will be quantified by a visual analogue scale - VAS; 0-10, ranging across a continuum from none (0) to a severe amount of pain (10).
3 secondary outcomes
Activity of carious lesions
Time frame: 3 Months
Patient Acceptance
Time frame: Only at baseline (begining, during and after procedure)
Operating Dentists' Opinion About the Procedure Performed
Time frame: Will be recorded immediately after the procedure
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 6 May 2021.
- Background: PubMed 24993261West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.
- Background: PubMed 28457477Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.
- Background: PubMed 32074885Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2018 Oct 15;40(6):152-161.
- Background: PubMed 26831727Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
- Background: PubMed 31590168Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of Dental Caries and Dental Caries Management: Consensus Report of a Workshop Organized by ORCA and Cariology Research Group of IADR. Caries Res. 2020;54(1):7-14. doi: 10.1159/000503309. Epub 2019 Oct 7.
- Background: PubMed 11405992Poulsen S, Errboe M, Hovgaard O, Worthington HW. Potassium nitrate toothpaste for dentine hypersensitivity. Cochrane Database Syst Rev. 2001;(2):CD001476. doi: 10.1002/14651858.CD001476.
- Background: PubMed 23224064Splieth CH, Tachou A. Epidemiology of dentin hypersensitivity. Clin Oral Investig. 2013 Mar;17 Suppl 1(Suppl 1):S3-8. doi: 10.1007/s00784-012-0889-8. Epub 2012 Dec 7.
- Background: PubMed 29258064Santamaria RM, Innes NPT, Machiulskiene V, Schmoeckel J, Alkilzy M, Splieth CH. Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial. Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.
- Background: PubMed 32854105Santamaria RM, Abudrya MH, Gul G, Mourad MS, Gomez GF, Zandona AGF. How to Intervene in the Caries Process: Dentin Caries in Primary Teeth. Caries Res. 2020;54(4):306-323. doi: 10.1159/000508899. Epub 2020 Aug 27.
- DA: Food and Drug Administration. Diammine Silver Fluoride Dental Hypersensitivity Varnish.Link provided by the sponsor.
- 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.
Mohamed H Abudrya, BDS, MSc. principal investigator
The Department of Preventive and Pediatric Dentistry, University of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®) and Sodium fluoride varnish (generic name; Duraphat®) in people with Dentin Hypersensitivity and Active Dental Caries, run by University Medicine Greifswald at 1 site in Germany.
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 4 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 6 May 2021. 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hypersensitivity pain relief (time frame: 3 Months). 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 NCT04804423, which also lists 9 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 6 May 2021.