Analgesics, OpioidADOPTNCT06275191
Alternatives to Dental Opioid Prescribing After Tooth Extraction
A study testing Multicomponent intervention in people with Analgesics, Opioid and Acute Pain, run by Douglas Oyler at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are: Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal? Do oral surgeons' beliefs about the intervention and opioid prescribing… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Analgesics, Opioid, Acute Pain, Tooth Extraction
- What is being tested?
- Multicomponent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38,159 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to Dec 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Actively U.S. licensed dentist or oral surgeon practicing at a participating cluster. Participating clinics were finalized prior to the beginning of the study based on the following criteria: (1) perform tooth extractions on at least 70 AYA patients during a 5-month screening period from July 1, 2022 through November 30, 2022 and (2) electronically prescribe opioids to at least 30% of AYA patients who underwent extraction during the screening period. Additionally, each participating cluster signed a data use agreement (DUA) for sharing electronic health record data, can provide the necessary electronic health record data, and agreed to comply with study procedures and be available for the duration of the study.
- Provide a signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- Undergoes any tooth extraction at a participating cluster during the study (intervention condition, transition period, or control condition) between 6-10 days earlier.
- Age 12-25 at the time of tooth extraction.
- Reads and acknowledges survey cover letter in lieu of a full consent/assent process.
- Can access the electronic survey using an internet-capable device.
Who cannot join
- There are no other exclusion criteria for clusters or provider/patient participants that meet all inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are:
- Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal?
- Do oral surgeons' beliefs about the intervention and opioid prescribing change?
- Do patients that report using opioids after tooth removal have different experiences than patients that do not?
Read more
Oral surgeon participants will:
- Attend a 1-hour education session with a trained pharmacist
- Receive patient instructions and blister packs of pain medicine to give to patients
- Complete 2 surveys about feasibility and appropriateness
Patient participants will complete a survey about pain and medication use after having a tooth removed.
Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.
Read the detailed description
Although use of nonsteroidal antiinflammatory drugs and acetaminophen is recommended first-line by the American Dental Association and American Association of Oral and Maxillofacial Surgeons, dentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. This multi-site, stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists and oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen (APAP) and ibuprofen for dispensing. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics (e.g., opioids). The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to the control condition (i.e., usual practice). Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.). Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management.
- Conditions
- Analgesics, Opioid, Acute Pain, Tooth Extraction, Adolescent, Acetaminophen, Ibuprofen
- Being tested
- Multicomponent intervention, Usual care
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent interventionBehavioural
The multicomponent intervention consists of (1) a single 45-60-minute academic detailing session with provider participants, plus (2) provision of patient post-extraction instruction materials and (3) provision of blister-packaged acetaminophen and ibuprofen for distribution to adolescent/young adult patients after tooth extraction in the course of clinical practice
Usual careOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | 1. Academic detailing (45 to 60-minute session), plus
2. Provision of standardized patient post-extraction instructions for distribution, plus
3. Provision of blister-packaged acetaminophen and ibuprofen at recommended standard doses for distribution to to adolescent/young adult patients after tooth extraction in the course of clinical practice Receives: Behavioral: Multicomponent intervention |
| Control condition | Active comparator | Usual practice Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction
The primary outcome is a patient-level binary indicator for being prescribed an opioid. The value for this outcome variable is equal to 1 if the patient is prescribed an opioid, whereas this variable takes on a value of 0 if this patient is not prescribed an opioid. Opioid prescription will be defined as an electronic order (from the electronic health record) for an opioid analgesic (e.g., hydrocodone, oxycodone, tramadol, morphine, fentanyl, etc.) on the same calendar date as the tooth extraction appointment.
Measured: Same calendar date as dental extraction. Electronic health records will be extracted for the duration of the 4-year study period.
Secondary outcomes (7)
(Change in) intervention feasibility
Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding feasibility of distributing blister packs and patient post-extraction materials. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.
Measured: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) intervention appropriateness
Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding appropriateness of distributing blister packs and patient post-extraction materials. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.
Measured: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) opioid prescribing feasibility
Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding feasibility of reducing opioid prescription. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.
Measured: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) opioid prescribing appropriateness
Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding appropriateness of reducing opioid prescription. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.
Measured: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
Self-reported pain
Patient survey, 3 items from Brief Pain Inventory (worst, least, average pain) based on self-reported opioid use. Each item uses an 11-point Visual Rating Scale from 0-no pain to 10-worst possible pain.
Measured: within 10 days of tooth extraction
Self-reported pain interference
Patient survey, NIH PROMIS Pediatric Short Form v1.0-Pain Interference 8a (age < 18) or NIH PROMIS Adult Short Form v1.0-Pain Interference 6b (18+) based on self-reported opioid use. NIH PROMIS Pediatric Short Form t-scores range from 34.0 to 78.0, with higher scores indicating greater interference. NIH PROMIS Adult Short Form t scores range from 41.0 to 78.3, with higher scores indicating greater interference.
Measured: within 10 days of tooth extraction
Self-reported pain satisfaction
Patient survey, 5-point Likert-type question (from 1-very unhappy to 5-very happy) regarding overall satisfaction with pain management based on self-reported opioid use. Selection of the top 2 choices (very happy or happy) from the scale is considered as satisfaction with overall pain management.
Measured: within 10 days of tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start16 Apr 2024
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Analgesics, OpioidStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge cluster randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38,159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Oyler
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor-investigator, Douglas Oyler, University of Kentucky
- Investigators
- Douglas R Oyler, PharmD, Principal investigator, University of KentuckyMarcia V Rojas Ramirez, DDS, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275191
- Sponsor's protocol ID
- 80758
- Other IDs
- 1UG3DE032621-01, 4UH3DE032621-02
- Acronym
- ADOPT
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oyler DR, Edgecombe SJ, Babusci EA, Dolly Prothro J, Begley AL, Rojas-Ramirez MV. Practical Fraud Detection and Prevention in Incentivized Online Surveys: Secondary Analysis of the ADOPT Study. J Med Internet Res. 2026 Jul 31;28:e90159. doi: 10.2196/90159.
PubMed 42536768Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Miller CS. Dental opioid prescription patterns in academic and community settings. J Public Health Dent. 2023 Jun;83(2):200-206. doi: 10.1111/jphd.12568. Epub 2023 Mar 11.
PubMed 36905202Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Bernard P, Surratt H, Miller CS. Factors influencing opioid prescribing after tooth extraction. J Am Dent Assoc. 2022 Sep;153(9):868-877. doi: 10.1016/j.adaj.2022.05.001. Epub 2022 Jun 9.
PubMed 35691709Oyler DR, Miller CS. Patterns of opioid prescribing in an Appalachian college of dentistry. J Am Dent Assoc. 2021 Mar;152(3):209-214. doi: 10.1016/j.adaj.2020.12.002.
PubMed 33632410Oyler DR, Westgate PM, Walsh SL, Dolly Prothro J, Miller CS, Roberts MF, Freeman PR, Knudsen HK, Lang M, Dominguez-Fernandez E, Rojas-Ramirez MV. Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial. BMC Oral Health. 2024 Apr 4;24(1):414. doi: 10.1186/s12903-024-04201-0.
PubMed 38575929
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternatives to Dental Opioid Prescribing After Tooth Extraction
- ClinicalTrials.gov ID
- NCT06275191
- Acronym / sponsor ID
- ADOPT / 80758
- Conditions
- Analgesics, Opioid, Acute Pain, Tooth Extraction, Adolescent, Acetaminophen, Ibuprofen
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38,159 participants (estimated)
- Lead sponsor
- Douglas OylerUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are:
- Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal?
- Do oral surgeons' beliefs about the intervention and opioid prescribing change?
- Do patients that report using opioids after tooth removal have different experiences than patients that do not?
Oral surgeon participants will:
- Attend a 1-hour education session with a trained pharmacist
- Receive patient instructions and blister packs of pain medicine to give to patients
- Complete 2 surveys about feasibility and appropriateness
Patient participants will complete a survey about pain and medication use after having a tooth removed.
Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.
Detailed description
Although use of nonsteroidal antiinflammatory drugs and acetaminophen is recommended first-line by the American Dental Association and American Association of Oral and Maxillofacial Surgeons, dentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. This multi-site, stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists and oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen (APAP) and ibuprofen for dispensing. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics (e.g., opioids). The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to the control condition (i.e., usual practice). Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.). Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: Multicomponent intervention1. Academic detailing (45 to 60-minute session), plus 2. Provision of standardized patient post-extraction instructions for distribution, plus 3. Provision of blister-packaged acetaminophen and ibuprofen at recommended standard doses for distribution to to adolescent/young adult patients after tooth extraction in the course of clinical practice |
| Control condition | Active comparator | Other: Usual careUsual practice |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Actively U.S. licensed dentist or oral surgeon practicing at a participating cluster. Participating clinics were finalized prior to the beginning of the study based on the following criteria: (1) perform tooth extractions on at least 70 AYA patients during a 5-month screening period from July 1, 2022 through November 30, 2022 and (2) electronically prescribe opioids to at least 30% of AYA patients who underwent extraction during the screening period. Additionally, each participating cluster signed a data use agreement (DUA) for sharing electronic health record data, can provide the necessary electronic health record data, and agreed to comply with study procedures and be available for the duration of the study.
- Provide a signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- Undergoes any tooth extraction at a participating cluster during the study (intervention condition, transition period, or control condition) between 6-10 days earlier.
- Age 12-25 at the time of tooth extraction.
Key exclusion criteria (1 listed)
- There are no other exclusion criteria for clusters or provider/patient participants that meet all inclusion criteria.
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 |
|---|---|---|
| Multicomponent interventionThe multicomponent intervention consists of (1) a single 45-60-minute academic detailing session with provider participants, plus (2) provision of patient post-extraction instruction materials and (3) provision of blister-packaged acetaminophen and ibuprofen for distribution to adolescent/young adult patients after tooth extraction in the course of clinical practice | Behavioural | Intervention condition |
| Usual careNo intervention. | Other | Control condition |
Primary outcome
Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction
Time frame: Same calendar date as dental extraction. Electronic health records will be extracted for the duration of the 4-year study period.
The primary outcome is a patient-level binary indicator for being prescribed an opioid. The value for this outcome variable is equal to 1 if the patient is prescribed an opioid, whereas this variable takes on a value of 0 if this patient is not prescribed an opioid. Opioid prescription will be defined as an electronic order (from the electronic health record) for an opioid analgesic (e.g., hydrocodone, oxycodone, tramadol, morphine, fentanyl, etc.) on the same calendar date as the tooth extraction appointment.
7 secondary outcomes
(Change in) intervention feasibility
Time frame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) intervention appropriateness
Time frame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) opioid prescribing feasibility
Time frame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
(Change in) opioid prescribing appropriateness
Time frame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
Self-reported pain
Time frame: within 10 days of tooth extraction
Self-reported pain interference
Time frame: within 10 days of tooth extraction
Self-reported pain satisfaction
Time frame: within 10 days of tooth extraction
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 10 Sep 2026.
- Background: PubMed 42536768Oyler DR, Edgecombe SJ, Babusci EA, Dolly Prothro J, Begley AL, Rojas-Ramirez MV. Practical Fraud Detection and Prevention in Incentivized Online Surveys: Secondary Analysis of the ADOPT Study. J Med Internet Res. 2026 Jul 31;28:e90159. doi: 10.2196/90159.
- Background: PubMed 36905202Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Miller CS. Dental opioid prescription patterns in academic and community settings. J Public Health Dent. 2023 Jun;83(2):200-206. doi: 10.1111/jphd.12568. Epub 2023 Mar 11.
- Background: PubMed 35691709Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Bernard P, Surratt H, Miller CS. Factors influencing opioid prescribing after tooth extraction. J Am Dent Assoc. 2022 Sep;153(9):868-877. doi: 10.1016/j.adaj.2022.05.001. Epub 2022 Jun 9.
- Background: PubMed 33632410Oyler DR, Miller CS. Patterns of opioid prescribing in an Appalachian college of dentistry. J Am Dent Assoc. 2021 Mar;152(3):209-214. doi: 10.1016/j.adaj.2020.12.002.
- Background: PubMed 38575929Oyler DR, Westgate PM, Walsh SL, Dolly Prothro J, Miller CS, Roberts MF, Freeman PR, Knudsen HK, Lang M, Dominguez-Fernandez E, Rojas-Ramirez MV. Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial. BMC Oral Health. 2024 Apr 4;24(1):414. doi: 10.1186/s12903-024-04201-0.
- 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.
Douglas R Oyler, PharmD principal investigator
University of Kentucky
Marcia V Rojas Ramirez, DDS principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention in people with Analgesics, Opioid and Acute Pain, run by Douglas Oyler at 1 site in United States.
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 7 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. 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 United States. 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?
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?
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?
Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction (time frame: Same calendar date as dental extraction. Electronic health records will be extracted for the duration of the 4-year study period.). 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 NCT06275191, which also lists 5 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 10 Sep 2026.