Dentin SensitivityNCT05309967
Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening
A study testing GLUMA DESINSITIZER in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
Tooth whitening is one of the most indicated aesthetic procedures in dentistry and there is evidence that it interferes with aspects of patients' quality of life. However, the sensitivity, associated with the post-procedure period, challenges clinicians and researchers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- GLUMA DESINSITIZER
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Mar 2021to 30 Jan 2023
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy incisors, canines and premolars;
- Do not having a diagnosis of dental hypersensitivity.
- Do not have been at desensitizing treatment in the past two years.
- Do not have been done dental whitening treatment.
Who cannot join
- Patients undergoing orthodontic treatment;
- Presence of periodontal disease;
- Presence of cracks or fractures in the teeth
- Presence of restorations and prostheses in anterior teeth;
- Presence of extensive restorations and/or deep in molars;
- Patients with serious dental darkening internal or external ;
Show all 9Show fewer
- Presence of exposed dentin.
- Pregnant and lactating women.
- Patients on active treatment whom are using anti-inflammatory drugs and painkillers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening : a Randomized, Single Blind and Split Mouth Clinical Trial.
Tooth whitening is one of the most indicated aesthetic procedures in dentistry and there is evidence that it interferes with aspects of patients' quality of life. However, the sensitivity, associated with the post-procedure period, challenges clinicians and researchers. The use of topic desensitizing agents could be a alternative for the control of this adverse effects of bleaching agents. The objective of this randomized clinical study, therefore, is to evaluate the effect of glutaraldehyde-based desensitizing agent associated on tooth sensitivity and tooth color after bleaching with 35% hydrogen peroxide. 25 patients will be selected divided into two groups for a double-blind and split-mouth study. Among the results it is expected: that the use of glutaraldehyde desensitizing agent helps in the control of post-bleaching sensitivity, without harming the final color obtained of patients submitted to the proposed clinical protocol.
Read the detailed description
Tooth whitening will be performed in 3 sessions with an interval of 7 days. Desensitizing agent and placebo will be applied in all sessions in a split mouth design . All groups will receive in-office bleaching treatment according to the steps described below:1 Prophylaxis; 2- Application of gingival barrier; 3- Application of the desensitizing product or placebo in accordance with the established groups; 4- Handling the bleaching material following the manufacturer's instructions: applications of whiteness HP35% bleaching gel for 15 minutes each, totaling 45 minutes; 5- Final removal of the whitening gel and the gingival barrier followed by washing with water.
Application of the desensitizer or its placebo (step 3) will follow the following sequence:1. Relative insulation with cotton rolls; 2- Active application of the product on the buccal surfaces of all teeth with the aid of a Microbrush for 10 seconds.; 3- Wait 60 seconds and apply a light jet of air until the tooth surface is no longer shiny; 4- Wash with water for 10 seconds.
To assess the patient's perception of pain, participants will be provided with a questionnaire to be filled out daily for 21 days from the first whitening treatment session. The criteria are based on the personal perception of the pain threshold, related to the level of sensitivity caused by bleaching treatment. The visual analogue scale (VAS) will be adopted as a reference. Numerical scale on which the number 0 (zero) corresponds to total absence of pain and 10 (ten) to maximum bearable pain.
The color records of the bleached teeth will be performed by a single evaluator who will do it session :T0- baseline, T1- a week after the first session; T2- a week after the second session; T3- a week after the third session. An area of interest for color registration will be the middle third of the buccal surface of the teeth, following the the guidelines of the American Dental Association. Visual analysis will be performed using a Vita Classical scale following a color scale order organized by value. A second color analysis will be performed with the aid of a spectrophotometer that acts according to the CIELab and CIEDE 2000 system. The region for color evaluation with the Easyshade will be standardized as the middle third of the buccal surface of the anterior teeth.
- Conditions
- Dentin Sensitivity
- Being tested
- GLUMA DESINSITIZER, PLACEBO
- Keywords
- Tooth Bleaching, dentin adhesives, tooth sensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLUMA DESINSITIZEROther
GLUTARALDEHYDE
PLACEBOOther
DESTILLED WATER
| Study group | Role | What they receive |
|---|---|---|
| GLUMA | Experimental | Glutaraldehyde + Hydroxyethyl methacrylate (GLUMA® Desensitizer) Receives: Other: GLUMA DESINSITIZER |
| PLACEBO | Placebo comparator | DISTILLED WATER Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of glutaraldehyde based material with or without low level laser therapy in tooth sensitivity during whitening protocol with 35 % hydrogen peroxide.
Self-reported pain intensity will be assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation will be performed by each patient, according to a numeric visual analog scale, as follows: 0 - 10. Where 0 correspond to no pain and 10 the most severe pain that patient have been ever identified
Measured: Patients will be evaluated during 21 days.
Use of glutaraldehyde based material with or without low level laser therapy in patient´s quality of life after whitening protocol with 35 % hydrogen peroxide.
A questionnaire will be applied before the bleaching treatment, after the completion of the bleaching treatment and 6 months after bleaching as a follow up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start13 Mar 2021
- Primary completion31 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a split mouth study composed of two groups randomized between left and right sides.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309967
- Sponsor's protocol ID
- UFpara-0012
- Status last verified
- Feb 2023
- First submitted
- 15 Mar 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Paula B, Alencar C, Ortiz M, Couto R, Araujo J, Silva C. Effect of photobiomodulation with low-level laser therapy combined with potassium nitrate on controlling post-bleaching tooth sensitivity: clinical, randomized, controlled, double-blind, and split-mouth study. Clin Oral Investig. 2019 Jun;23(6):2723-2732. doi: 10.1007/s00784-018-2715-4. Epub 2018 Oct 25.
PubMed 30361793Shulman JD, Maupome G, Clark DC, Levy SM. Perceptions of desirable tooth color among parents, dentists and children. J Am Dent Assoc. 2004 May;135(5):595-604; quiz 654-5. doi: 10.14219/jada.archive.2004.0247.
PubMed 15202751Alkhatib MN, Holt R, Bedi R. Prevalence of self-assessed tooth discolouration in the United Kingdom. J Dent. 2004 Sep;32(7):561-6. doi: 10.1016/j.jdent.2004.06.002.
PubMed 15386863Rezende M, Loguercio AD, Kossatz S, Reis A. Predictive factors on the efficacy and risk/intensity of tooth sensitivity of dental bleaching: A multi regression and logistic analysis. J Dent. 2016 Feb;45:1-6. doi: 10.1016/j.jdent.2015.11.003. Epub 2015 Dec 2.
PubMed 26612623Kwon SR, Wertz PW. Review of the Mechanism of Tooth Whitening. J Esthet Restor Dent. 2015 Sep-Oct;27(5):240-57. doi: 10.1111/jerd.12152. Epub 2015 May 13.
PubMed 25969131Cardenas AFM, Maran BM, Araujo LCR, de Siqueira FSF, Wambier LM, Gonzaga CC, Loguercio AD, Reis A. Are combined bleaching techniques better than their sole application? A systematic review and meta-analysis. Clin Oral Investig. 2019 Oct;23(10):3673-3689. doi: 10.1007/s00784-019-03042-4. Epub 2019 Aug 29.
PubMed 31468261Kwon SR, Dawson DV, Schenck DM, Fiegel J, Wertz PW. Spectrophotometric Evaluation of Potassium Nitrate Penetration Into the Pulp Cavity. Oper Dent. 2015 Nov-Dec;40(6):614-21. doi: 10.2341/14-214-L. Epub 2015 Jul 7.
PubMed 26151563Klaric Sever E, Budimir Z, Cerovac M, Stambuk M, Par M, Negovetic Vranic D, Tarle Z. Clinical and patient reported outcomes of bleaching effectiveness. Acta Odontol Scand. 2018 Jan;76(1):30-38. doi: 10.1080/00016357.2017.1376111. Epub 2017 Sep 11.
PubMed 28893130Caviedes-Bucheli J, Ariza-Garcia G, Restrepo-Mendez S, Rios-Osorio N, Lombana N, Munoz HR. The effect of tooth bleaching on substance P expression in human dental pulp. J Endod. 2008 Dec;34(12):1462-5. doi: 10.1016/j.joen.2008.09.013. Epub 2008 Oct 31.
PubMed 19026874Vaz MM, Lopes LG, Cardoso PC, Souza JB, Batista AC, Costa NL, Torres EM, Estrela C. Inflammatory response of human dental pulp to at-home and in-office tooth bleaching. J Appl Oral Sci. 2016 Sep-Oct;24(5):509-517. doi: 10.1590/1678-775720160137.
PubMed 27812622Marto CM, Baptista Paula A, Nunes T, Pimenta M, Abrantes AM, Pires AS, Laranjo M, Coelho A, Donato H, Botelho MF, Marques Ferreira M, Carrilho E. Evaluation of the efficacy of dentin hypersensitivity treatments-A systematic review and follow-up analysis. J Oral Rehabil. 2019 Oct;46(10):952-990. doi: 10.1111/joor.12842. Epub 2019 Jul 12.
PubMed 31216069de Melo Alencar C, Castro da Silva R, Nogueira Araujo JL, Silva da Silveira AD, Martins Silva C. A clinical, randomized, double-blind study on the use of toothpastes immediately after at-home tooth bleaching. Am J Dent. 2017 Oct;30(5):267-271.
PubMed 29178730Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
PubMed 26964798Pompeu DDS, de Paula BLF, Barros APO, Nunes SC, Carneiro AMP, Araujo JLN, Silva CM. Combination of strontium chloride and photobiomodulation in the control of tooth sensitivity post-bleaching: A split-mouth randomized clinical trial. PLoS One. 2021 Apr 28;16(4):e0250501. doi: 10.1371/journal.pone.0250501. eCollection 2021.
PubMed 33909659Diniz A, Lima S, Tavarez R, Borges AH, Pinto S, Tonetto MR, Loguercio AD, Bandeca MC. Preventive Use of a Resin-based Desensitizer Containing Glutaraldehyde on Tooth Sensitivity Caused by In-office Bleaching: A Randomized, Single-blind Clinical Trial. Oper Dent. 2018 Sep/Oct;43(5):472-481. doi: 10.2341/17-020-C. Epub 2018 Mar 23.
PubMed 29570018
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening : a Randomized, Single Blind and Split Mouth Clinical Trial.
- ClinicalTrials.gov ID
- NCT05309967
- Acronym / sponsor ID
- UFpara-0012
- Conditions
- Dentin Sensitivity
- Keywords
- Tooth Bleaching, dentin adhesives, tooth sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 13 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 4 Apr 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.
Tooth whitening is one of the most indicated aesthetic procedures in dentistry and there is evidence that it interferes with aspects of patients' quality of life. However, the sensitivity, associated with the post-procedure period, challenges clinicians and researchers. The use of topic desensitizing agents could be a alternative for the control of this adverse effects of bleaching agents. The objective of this randomized clinical study, therefore, is to evaluate the effect of glutaraldehyde-based desensitizing agent associated on tooth sensitivity and tooth color after bleaching with 35% hydrogen peroxide. 25 patients will be selected divided into two groups for a double-blind and split-mouth study. Among the results it is expected: that the use of glutaraldehyde desensitizing agent helps in the control of post-bleaching sensitivity, without harming the final color obtained of patients submitted to the proposed clinical protocol.
Detailed description
Tooth whitening will be performed in 3 sessions with an interval of 7 days. Desensitizing agent and placebo will be applied in all sessions in a split mouth design . All groups will receive in-office bleaching treatment according to the steps described below:1 Prophylaxis; 2- Application of gingival barrier; 3- Application of the desensitizing product or placebo in accordance with the established groups; 4- Handling the bleaching material following the manufacturer's instructions: applications of whiteness HP35% bleaching gel for 15 minutes each, totaling 45 minutes; 5- Final removal of the whitening gel and the gingival barrier followed by washing with water.
Application of the desensitizer or its placebo (step 3) will follow the following sequence:1. Relative insulation with cotton rolls; 2- Active application of the product on the buccal surfaces of all teeth with the aid of a Microbrush for 10 seconds.; 3- Wait 60 seconds and apply a light jet of air until the tooth surface is no longer shiny; 4- Wash with water for 10 seconds.
To assess the patient's perception of pain, participants will be provided with a questionnaire to be filled out daily for 21 days from the first whitening treatment session. The criteria are based on the personal perception of the pain threshold, related to the level of sensitivity caused by bleaching treatment. The visual analogue scale (VAS) will be adopted as a reference. Numerical scale on which the number 0 (zero) corresponds to total absence of pain and 10 (ten) to maximum bearable pain.
The color records of the bleached teeth will be performed by a single evaluator who will do it session :T0- baseline, T1- a week after the first session; T2- a week after the second session; T3- a week after the third session. An area of interest for color registration will be the middle third of the buccal surface of the teeth, following the the guidelines of the American Dental Association. Visual analysis will be performed using a Vita Classical scale following a color scale order organized by value. A second color analysis will be performed with the aid of a spectrophotometer that acts according to the CIELab and CIEDE 2000 system. The region for color evaluation with the Easyshade will be standardized as the middle third of the buccal surface of the anterior teeth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- It is a split mouth study composed of two groups randomized between left and right sides.
| Arm | Type | Receives |
|---|---|---|
| GLUMA | Experimental | Other: GLUMA DESINSITIZERGlutaraldehyde + Hydroxyethyl methacrylate (GLUMA® Desensitizer) |
| PLACEBO | Placebo comparator | Other: PLACEBODISTILLED WATER |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy incisors, canines and premolars;
- Do not having a diagnosis of dental hypersensitivity.
- Do not have been at desensitizing treatment in the past two years.
- Do not have been done dental whitening treatment.
Key exclusion criteria (9 listed)
- Patients undergoing orthodontic 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 |
|---|---|---|
| GLUMA DESINSITIZERGLUTARALDEHYDE | Other | GLUMA |
| PLACEBODESTILLED WATER | Other | PLACEBO |
Primary outcome
Use of glutaraldehyde based material with or without low level laser therapy in tooth sensitivity during whitening protocol with 35 % hydrogen peroxide.
Time frame: Patients will be evaluated during 21 days.
Self-reported pain intensity will be assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation will be performed by each patient, according to a numeric visual analog scale, as follows: 0 - 10. Where 0 correspond to no pain and 10 the most severe pain that patient have been ever identified
Use of glutaraldehyde based material with or without low level laser therapy in patient´s quality of life after whitening protocol with 35 % hydrogen peroxide.
Time frame: 6 months
A questionnaire will be applied before the bleaching treatment, after the completion of the bleaching treatment and 6 months after bleaching as a follow up
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 28 Feb 2023.
- Background: PubMed 30361793de Paula B, Alencar C, Ortiz M, Couto R, Araujo J, Silva C. Effect of photobiomodulation with low-level laser therapy combined with potassium nitrate on controlling post-bleaching tooth sensitivity: clinical, randomized, controlled, double-blind, and split-mouth study. Clin Oral Investig. 2019 Jun;23(6):2723-2732. doi: 10.1007/s00784-018-2715-4. Epub 2018 Oct 25.
- Background: PubMed 15202751Shulman JD, Maupome G, Clark DC, Levy SM. Perceptions of desirable tooth color among parents, dentists and children. J Am Dent Assoc. 2004 May;135(5):595-604; quiz 654-5. doi: 10.14219/jada.archive.2004.0247.
- Background: PubMed 15386863Alkhatib MN, Holt R, Bedi R. Prevalence of self-assessed tooth discolouration in the United Kingdom. J Dent. 2004 Sep;32(7):561-6. doi: 10.1016/j.jdent.2004.06.002.
- Background: PubMed 26612623Rezende M, Loguercio AD, Kossatz S, Reis A. Predictive factors on the efficacy and risk/intensity of tooth sensitivity of dental bleaching: A multi regression and logistic analysis. J Dent. 2016 Feb;45:1-6. doi: 10.1016/j.jdent.2015.11.003. Epub 2015 Dec 2.
- Background: PubMed 25969131Kwon SR, Wertz PW. Review of the Mechanism of Tooth Whitening. J Esthet Restor Dent. 2015 Sep-Oct;27(5):240-57. doi: 10.1111/jerd.12152. Epub 2015 May 13.
- Background: PubMed 31468261Cardenas AFM, Maran BM, Araujo LCR, de Siqueira FSF, Wambier LM, Gonzaga CC, Loguercio AD, Reis A. Are combined bleaching techniques better than their sole application? A systematic review and meta-analysis. Clin Oral Investig. 2019 Oct;23(10):3673-3689. doi: 10.1007/s00784-019-03042-4. Epub 2019 Aug 29.
- Background: PubMed 26151563Kwon SR, Dawson DV, Schenck DM, Fiegel J, Wertz PW. Spectrophotometric Evaluation of Potassium Nitrate Penetration Into the Pulp Cavity. Oper Dent. 2015 Nov-Dec;40(6):614-21. doi: 10.2341/14-214-L. Epub 2015 Jul 7.
- Background: PubMed 28893130Klaric Sever E, Budimir Z, Cerovac M, Stambuk M, Par M, Negovetic Vranic D, Tarle Z. Clinical and patient reported outcomes of bleaching effectiveness. Acta Odontol Scand. 2018 Jan;76(1):30-38. doi: 10.1080/00016357.2017.1376111. Epub 2017 Sep 11.
- Background: PubMed 19026874Caviedes-Bucheli J, Ariza-Garcia G, Restrepo-Mendez S, Rios-Osorio N, Lombana N, Munoz HR. The effect of tooth bleaching on substance P expression in human dental pulp. J Endod. 2008 Dec;34(12):1462-5. doi: 10.1016/j.joen.2008.09.013. Epub 2008 Oct 31.
- Background: PubMed 27812622Vaz MM, Lopes LG, Cardoso PC, Souza JB, Batista AC, Costa NL, Torres EM, Estrela C. Inflammatory response of human dental pulp to at-home and in-office tooth bleaching. J Appl Oral Sci. 2016 Sep-Oct;24(5):509-517. doi: 10.1590/1678-775720160137.
- Background: PubMed 31216069Marto CM, Baptista Paula A, Nunes T, Pimenta M, Abrantes AM, Pires AS, Laranjo M, Coelho A, Donato H, Botelho MF, Marques Ferreira M, Carrilho E. Evaluation of the efficacy of dentin hypersensitivity treatments-A systematic review and follow-up analysis. J Oral Rehabil. 2019 Oct;46(10):952-990. doi: 10.1111/joor.12842. Epub 2019 Jul 12.
- Background: PubMed 29178730de Melo Alencar C, Castro da Silva R, Nogueira Araujo JL, Silva da Silveira AD, Martins Silva C. A clinical, randomized, double-blind study on the use of toothpastes immediately after at-home tooth bleaching. Am J Dent. 2017 Oct;30(5):267-271.
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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 GLUMA DESINSITIZER in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
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 9 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 28 Feb 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Use of glutaraldehyde based material with or without low level laser therapy in tooth sensitivity during whitening protocol with 35 % hydrogen peroxide. (time frame: Patients will be evaluated during 21 days.). The study lists 2 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 NCT05309967, which also lists 20 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 28 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.