Dental AnxietyNCT05500261
Intranasal Dexmedetomidine for Severe Dental Anxiety: a Randomized Trial
A study testing Dexmedetomidine in people with Dental Anxiety, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Patients with dental anxiety only develop anxiety and fear about dental treatments. Patients with severe dental anxiety have difficulty cooperating with dental treatments, and can only complete dental treatments through general anesthesia, or even abandon treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2026to 23 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully understand the purpose and significance of this trial, voluntarily participate in this clinical trial, and voluntarily sign an informed consent form;
- Age 18 to 65 years old, regardless of gender;
- Diagnosed by a dentist and needs dental treatment;
- Can be immediately arranged for dental treatment after being evaluated by the clinician as having no contraindications;
- Graded as severe dental anxious (obtained using the MDAS modified dental anxiety scale);
- After controlling the symptoms of infection if with symptoms of acute/systemic infection, and can be arranged immediately after meeting the indications for dental treatments;
Show all 9Show fewer
- BMI is 18.5 kg/m2~25 kg/m2;
- After resting for 30 min, the SBP < 180 mmHg, the DBP < 110 mmHg, and the 60≤HR ≤ 120 bpm;
- For women who have not been menopausal or who have been under 1 year of menopause, a pregnancy test (blood or urine pregnancy test) should be performed during the screening period, and then the study and administration should be carried out after the pregnancy test is negative during the screening period.
Who cannot join
- Subjects who are not considered by the researcher to be suitable for nasal drops (such as severe rhinitis, nasal malformations, etc.);
- Subjects with a history of severe arrhythmias such as type II or above AV block or a history of cardiac insufficiency;
- Subjects with a history of myocardial infarction or unstable angina in the 6 months before the screening period;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA);
- Subjects with poor blood pressure control after drug therapy (hypertension: SBP≥180 mmHg, and/or DBP≥110 mmHg, or hypotension: SBP <90 mmHg and/or DBP≤50 mmHg);
- Subjects with psychiatric disorders (such as schizophrenia, anxiety, depression, etc.) and cognitive dysfunction, or have a history of epilepsy, or previous abuse of psychotropic drugs and narcotic drugs;
Show all 13Show fewer
- Subjects with a history of difficult airway disease or possibility, such as obstructive sleep apnea syndrome;
- Randomly, within 1 year of random, a history of drug abuse, a history of drug abuse and a history of alcohol abuse, i.e., a subject who drank more than 2 units of alcohol per day on average (1 unit = 360 ml of beer or 45 ml of liquor or 150 ml of wine with an alcohol content of 40%);
- Subjects who received selective alpha2-adrenoceptor agonists or antagonists within 14 days of randomization;
- Those who are allergic to dexmedetomidine hydrochloride or items used in stomatology;
- Pregnant or nursing women;
- Those who have a birth plan within 30 days before the screening period and half a year after the end of the trial, and are unwilling or unable to take effective contraception measures;
- Other circumstances in which the investigator determines that the subject is not suitable to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Anxiolytic Effect of Intranasal Dexmedetomidine for Severely Anxious Patients in Dental Treatments
Patients with dental anxiety only develop anxiety and fear about dental treatments. Patients with severe dental anxiety have difficulty cooperating with dental treatments, and can only complete dental treatments through general anesthesia, or even abandon treatments. Dexmedetomidine is a potent, highly selective α2-adrenoceptor agonist, which provides good anxiolytic, sedative and analgesic effects and is commonly used in anesthesiology and intensive care medicine departments, routinely intravenously. In recent years, intranasal administration of dexmedetomidine has also been reported for pediatric dentistry and adult alveolar surgery, showing good sedative and analgesic effects. However, these studies have problems such as single surgical types, small sample size, and few indicators analyzed. Therefore, the evaluation of intranasal administration of dexmedetomidine is still not comprehensive enough. Besides, the anxiolytic effect of dexmedetomidine for dental anxiety has not been reported yet. This project plans to carry out a randomized, double-blinded, placebo-controlled, two-stage clinical trial. We will firstly explore a reasonable dose, and secondly verify it with placebo as the control. We plan to measure the object indicators, including the NTI value, plasma cortisol, interleukin-6, blood pressure and heart rate, and to assess the subjective indicators using scales and questionnaires, thus comprehensively evaluating the effectiveness, safety and feasibility of the anxiolytic effect of intranasal dexmedetomidine for severe dental anxious patients, and preliminary exploring its mechanism additionally. We intend to help severe dental anxious patients completing dental treatments.
- Conditions
- Dental Anxiety
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Intranasal, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called intranasal, randomized controlled trial, dental anxiety
intranasal administration of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| 0.8 μg/kg intranasal dexmedetomidine | Experimental | Intranasal administration of 0.8 μg/kg dexmedetomidine Receives: Drug: Dexmedetomidine |
| 1.5 μg/kg intranasal dexmedetomidine | Experimental | Intranasal administration of 1.5 μg/kg dexmedetomidine Receives: Drug: Dexmedetomidine |
| 2.0 μg/kg intranasal dexmedetomidine | Experimental | Intranasal administration of 2.0 μg/kg dexmedetomidine Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MDAS score
Dental anxious score will be accessed by modified dental anxiety scale (MDAS), and the change of MDAS score will be calculated as the scores right after dental treatments minus the initial score before intervention.
Measured: Change from baseline MDAS score right after finishing dental treatments, an average of 30 minutes
Secondary outcomes (7)
Change of plasma cortisol concentration
The change of plasma cortisol concentration will be calculated as the values right after dental treatments minus the initial values before intervention.
Measured: Change from baseline plasma cortisol concentration right after finishing dental treatments, an average of 30 minutes
Change of NTI score
The depth of sedation will be accessed by NTI score using Narcotrend, and the change of NTI score will be calculated as the score right after dental treatments minus the initial score before intervention.
Measured: Change from baseline NTI score right after finishing dental treatments, an average of 30 minutes
Change of OAA/S score
OAA/S score will be accessed by observer's assessment of alertness/sedation scale (OAA/S), which also represent the depth of sedation, and the change of OAA/S score will be calculated as the score right after dental treatments minus the initial score before intervention.
Measured: Change from baseline OAA/S score right after finishing dental treatments, an average of 30 minutes
Change of blood pressure (BP)
BP will be continuously accessed using an electrocardiogram monitor throughout the whole clinical process. BP value will be converted into mean arterial pressure (MAP) for comparison using the formula: MAP = (SBP + 2 × DBP)/3. Then the change of BP was presented as ΔMAP, which was calculated as the MAP at the point with the highest SBP minus the initial MAP right before the procedure.
Measured: Change from baseline BP right after finishing dental treatments, an average of 30 minutes.
Change of heart rate (HR)
HR will be continuously accessed using an electrocardiogram monitor throughout the whole clinical process. Change of HR equaled the corresponding HR of the highest SBP subtracted by the initial HR.
Measured: Change from baseline HR right after finishing dental treatments, an average of 30 minutes.
Pain score
Pain score will be obtained via visual analogue scale (MDAS) for the subject to fill.
Measured: Through the completion of dental treatments, an average of 30 minutes.
Percentage of thinking feasible of intranasal dexmedetomidine by participants
The feasibility of intranasal dexmedetomidine will be assessed through semistructured questionnaires. Items includes the reasons for nonparticipation; the acceptability of the trial and intranasal dexmedetomidine to participants; and the experience of the patients, the clinician performing the procedure, and the nursing staff taking care for patients during the study. The patients and clinic staffs filled the questionnaires right after the extraction process under our instruction. The outcome of the questionnaires was analyzed through counting and reported as a percentage (%).
Measured: Through the completion of dental treatments, an average of 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start8 Sep 2026 (estimated)
- Primary completion23 Jul 2028 (estimated)
- Study completion23 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeman Qin, Master, Principal investigator, Department of General Dentistry, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500261
- Sponsor's protocol ID
- SYSKY-2022-119-03
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the data will be shared after publication of the paper of this trial
Publications
Uusalo P, Guillaume S, Siren S, Manner T, Vilo S, Scheinin M, Saari TI. Pharmacokinetics and Sedative Effects of Intranasal Dexmedetomidine in Ambulatory Pediatric Patients. Anesth Analg. 2020 Apr;130(4):949-957. doi: 10.1213/ANE.0000000000004264.
PubMed 31206433Yoo H, Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT, Jusko WJ. Mechanism-based population pharmacokinetic and pharmacodynamic modeling of intravenous and intranasal dexmedetomidine in healthy subjects. Eur J Clin Pharmacol. 2015 Oct;71(10):1197-207. doi: 10.1007/s00228-015-1913-0. Epub 2015 Aug 2.
PubMed 26233335Coursin DB, Coursin DB, Maccioli GA. Dexmedetomidine. Curr Opin Crit Care. 2001 Aug;7(4):221-6. doi: 10.1097/00075198-200108000-00002.
PubMed 11571417Shetty SK, Aggarwal G. Efficacy of Intranasal Dexmedetomidine for Conscious Sedation in Patients Undergoing Surgical Removal of Impacted Third Molar: A Double-Blind Split Mouth Study. J Maxillofac Oral Surg. 2016 Dec;15(4):512-516. doi: 10.1007/s12663-016-0889-3. Epub 2016 Apr 21.
PubMed 27833345Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.
PubMed 23497981Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.
PubMed 21685111Liu S, Wang Y, Zhu Y, Yu T, Zhao H. Safety and sedative effect of intranasal dexmedetomidine in mandibular third molar surgery: a systematic review and meta-analysis. Drug Des Devel Ther. 2019 Apr 23;13:1301-1310. doi: 10.2147/DDDT.S194894. eCollection 2019.
PubMed 31114165Ryu DS, Lee DW, Choi SC, Oh IH. Sedation Protocol Using Dexmedetomidine for Third Molar Extraction. J Oral Maxillofac Surg. 2016 May;74(5):926.e1-7. doi: 10.1016/j.joms.2015.12.021. Epub 2016 Jan 7.
PubMed 26850877
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anxiolytic Effect of Intranasal Dexmedetomidine for Severely Anxious Patients in Dental Treatments
- ClinicalTrials.gov ID
- NCT05500261
- Acronym / sponsor ID
- SYSKY-2022-119-03
- Conditions
- Dental Anxiety
- Keywords
- Dexmedetomidine, Intranasal, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 23 Jul 2028 (estimated)
- Study completion
- 23 Jul 2028 (estimated)
- First posted
- 15 Aug 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.
Patients with dental anxiety only develop anxiety and fear about dental treatments. Patients with severe dental anxiety have difficulty cooperating with dental treatments, and can only complete dental treatments through general anesthesia, or even abandon treatments. Dexmedetomidine is a potent, highly selective α2-adrenoceptor agonist, which provides good anxiolytic, sedative and analgesic effects and is commonly used in anesthesiology and intensive care medicine departments, routinely intravenously. In recent years, intranasal administration of dexmedetomidine has also been reported for pediatric dentistry and adult alveolar surgery, showing good sedative and analgesic effects. However, these studies have problems such as single surgical types, small sample size, and few indicators analyzed. Therefore, the evaluation of intranasal administration of dexmedetomidine is still not comprehensive enough. Besides, the anxiolytic effect of dexmedetomidine for dental anxiety has not been reported yet. This project plans to carry out a randomized, double-blinded, placebo-controlled, two-stage clinical trial. We will firstly explore a reasonable dose, and secondly verify it with placebo as the control. We plan to measure the object indicators, including the NTI value, plasma cortisol, interleukin-6, blood pressure and heart rate, and to assess the subjective indicators using scales and questionnaires, thus comprehensively evaluating the effectiveness, safety and feasibility of the anxiolytic effect of intranasal dexmedetomidine for severe dental anxious patients, and preliminary exploring its mechanism additionally. We intend to help severe dental anxious patients completing dental treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.8 μg/kg intranasal dexmedetomidine | Experimental | Drug: DexmedetomidineIntranasal administration of 0.8 μg/kg dexmedetomidine |
| 1.5 μg/kg intranasal dexmedetomidine | Experimental | Drug: DexmedetomidineIntranasal administration of 1.5 μg/kg dexmedetomidine |
| 2.0 μg/kg intranasal dexmedetomidine | Experimental | Drug: DexmedetomidineIntranasal administration of 2.0 μg/kg dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand the purpose and significance of this trial, voluntarily participate in this clinical trial, and voluntarily sign an informed consent form;
- Age 18 to 65 years old, regardless of gender;
- Diagnosed by a dentist and needs dental treatment;
- Can be immediately arranged for dental treatment after being evaluated by the clinician as having no contraindications;
- Graded as severe dental anxious (obtained using the MDAS modified dental anxiety scale);
Key exclusion criteria (13 listed)
- Subjects who are not considered by the researcher to be suitable for nasal drops (such as severe rhinitis, nasal malformations, etc.);
- Subjects with a history of severe arrhythmias such as type II or above AV block or a history of cardiac insufficiency;
- Subjects with a history of myocardial infarction or unstable angina in the 6 months before the screening period;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA);
- Subjects with poor blood pressure control after drug therapy (hypertension: SBP≥180 mmHg, and/or DBP≥110 mmHg, or hypotension: SBP <90 mmHg and/or DBP≤50 mmHg);
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 |
|---|---|---|
| DexmedetomidineAlso: intranasal, randomized controlled trial, dental anxietyintranasal administration of dexmedetomidine | Drug | 0.8 μg/kg intranasal dexmedetomidine, 1.5 μg/kg intranasal dexmedetomidine, 2.0 μg/kg intranasal dexmedetomidine |
Primary outcome
Change of MDAS score
Time frame: Change from baseline MDAS score right after finishing dental treatments, an average of 30 minutes
Dental anxious score will be accessed by modified dental anxiety scale (MDAS), and the change of MDAS score will be calculated as the scores right after dental treatments minus the initial score before intervention.
7 secondary outcomes
Change of plasma cortisol concentration
Time frame: Change from baseline plasma cortisol concentration right after finishing dental treatments, an average of 30 minutes
Change of NTI score
Time frame: Change from baseline NTI score right after finishing dental treatments, an average of 30 minutes
Change of OAA/S score
Time frame: Change from baseline OAA/S score right after finishing dental treatments, an average of 30 minutes
Change of blood pressure (BP)
Time frame: Change from baseline BP right after finishing dental treatments, an average of 30 minutes.
Change of heart rate (HR)
Time frame: Change from baseline HR right after finishing dental treatments, an average of 30 minutes.
Pain score
Time frame: Through the completion of dental treatments, an average of 30 minutes.
Percentage of thinking feasible of intranasal dexmedetomidine by participants
Time frame: Through the completion of dental treatments, an average of 30 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 31206433Uusalo P, Guillaume S, Siren S, Manner T, Vilo S, Scheinin M, Saari TI. Pharmacokinetics and Sedative Effects of Intranasal Dexmedetomidine in Ambulatory Pediatric Patients. Anesth Analg. 2020 Apr;130(4):949-957. doi: 10.1213/ANE.0000000000004264.
- Background: PubMed 26233335Yoo H, Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT, Jusko WJ. Mechanism-based population pharmacokinetic and pharmacodynamic modeling of intravenous and intranasal dexmedetomidine in healthy subjects. Eur J Clin Pharmacol. 2015 Oct;71(10):1197-207. doi: 10.1007/s00228-015-1913-0. Epub 2015 Aug 2.
- Background: PubMed 11571417Coursin DB, Coursin DB, Maccioli GA. Dexmedetomidine. Curr Opin Crit Care. 2001 Aug;7(4):221-6. doi: 10.1097/00075198-200108000-00002.
- Results publication: PubMed 27833345Shetty SK, Aggarwal G. Efficacy of Intranasal Dexmedetomidine for Conscious Sedation in Patients Undergoing Surgical Removal of Impacted Third Molar: A Double-Blind Split Mouth Study. J Maxillofac Oral Surg. 2016 Dec;15(4):512-516. doi: 10.1007/s12663-016-0889-3. Epub 2016 Apr 21.
- Results publication: PubMed 23497981Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.
- Results publication: PubMed 21685111Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.
- Results publication: PubMed 31114165Liu S, Wang Y, Zhu Y, Yu T, Zhao H. Safety and sedative effect of intranasal dexmedetomidine in mandibular third molar surgery: a systematic review and meta-analysis. Drug Des Devel Ther. 2019 Apr 23;13:1301-1310. doi: 10.2147/DDDT.S194894. eCollection 2019.
- Results publication: PubMed 26850877Ryu DS, Lee DW, Choi SC, Oh IH. Sedation Protocol Using Dexmedetomidine for Third Molar Extraction. J Oral Maxillofac Surg. 2016 May;74(5):926.e1-7. doi: 10.1016/j.joms.2015.12.021. Epub 2016 Jan 7.
- Individual participant dataSharing planned: Yes. All of the data will be shared after publication of the paper of this trial
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
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.
Zeman Qin, Master principal investigator
Department of General Dentistry, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Dental Anxiety, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeman Qin, Master (15018419746, qinzm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MDAS score (time frame: Change from baseline MDAS score right after finishing dental treatments, an average of 30 minutes). 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 NCT05500261, which also lists 8 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 30 Sep 2026.