Primary Dental CariesPAPRICANCT03696498
Effects of Partical Excavation in One Versus Two Procedures of Primary Deep Caries (PAPRICA)
A study testing Resin restoration (1 step) and Resin restoration (2 steps) in people with Primary Dental Caries, run by University of Copenhagen at 11 sites in 4 countries.
Trial summary
Background: Deep caries is the most frequent reason for performing root canal treatments. Minimally invasive methods for the treatment of deep carious lesions might therefore be relevant to avoid pulp exposures and consequently to prevent root canal treatments. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Dental Caries
- What is being tested?
- Resin restoration (1 step) and Resin restoration (2 steps)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Jan 2015to Dec 2024
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults and children >9 years.
- Primary coronal caries without pain in a permanent tooth (pain is accepted when evoked by a hot, cold, or sweet stimulus of short duration and disappears when the stimulus is removed).
- The radiograph shows caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine.
- No exposure of the pulp following the first excavation.
- Available for recall at 1 and 3 years.
- Written informed consent.
Who cannot join
- Actual deep carious tooth presenting spontaneous and/or prolonged pain within the last 6 months, or pain causing disturbed night sleep.
- Actual deep carious tooth with negative thermal and/or electrical pulp test.
- Radiograph shows apical or radicular radiolucency of the tooth.
- Deep carious tooth has restoration in close contact with pulp.
- No written informed consent.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Denmark8 sites
PDHS - Aarhus municipality
Aarhus, Viby J, 8260
PDHS - Brøndby
Brøndby, 2605
University of Copenhagen
Copenhagen, Copenhagen N, 2200
PDHS - Copenhagen municipality
Copenhagen, Copenhagen V, 1662
PDHS - Gentofte
Gentofte Municipality, Charlottenlund, 2920
PDHS - Hørsholm
Hørsholm, Rungsted Kyst, 2960
PDHS - Randers municipality
Randers, Randers C, 8900
PDHS - Bornholm
Rønne, Bornholm, 3700
About this study
Official title: Effects of PArtial Excavation in One Procedure Versus Partial Excavation in Two Procedures of PRImary Deep CAries in Permanent Teeth - A Randomised, Multicenter Clinical Superiority Trial With Blinded Outcome Assessment
Background: Deep caries is the most frequent reason for performing root canal treatments. Minimally invasive methods for the treatment of deep carious lesions might therefore be relevant to avoid pulp exposures and consequently to prevent root canal treatments. A 2 step carious removal approach has shown to avoid exposures. But we do not know whether a selective removal of carious tissue in well-defined deep caries lesions involving the pulpal quarter of the dentin can be successfully completed in 1 step.
Objectives: To investigate partial (selective) excavation by 1 vs 2 step in the treatment of deep caries in permanent teeth.
Read more
Design: RCT multinational superiority study with 2 parallel groups and blinded outcome assessment. The allocation sequence for partial (selective) carious removal vs 2 step stepwise carious removal (1:1) will be centralized and computer-generated, stratified for age and centre and concealed for the investigators.
Inclusion criteria: children (≥9 years) and adults with primary well-defined deep caries in a permanent tooth. The lesion should reach the pulpal ¼ of the dentin with presence of a radiodense zone on a bitewing.
Exclusion criteria: spontaneous and prolonged pain within the last 6 months; pain causing disturbed night sleep; negative pulp test; apical radiolucency; restoration in close contact with pulp; the patient has communication problems; no written informed consent.
Experimental intervention: 1-step selective carious removal to soft or firm dentine at central site , and peripheral non selective carious removal to hard dentin followed by a permanent resin restoration. Control intervention: Stepwise excavation (2- step, involving first step which is identical to the experimental intervention but a base material and a temporary glass-ionomer restoration is placed. The amount removed is as much as a proper restoration can be placed. After 4-6 months the patients are recalled and the temporary restoration is removed and final selective carious removal is completed until firm dentin remains followed by permanent resin restoration.
The primary outcome is to avoid pulp complication at the 1-year follow-up evaluating. The secondary outcomes are to arrest caries progression and sufficient restoration at the 1-year follow-up. All outcomes will further be assessed 3 years after inclusion.
Read the detailed description
Originality of the project: The originality of the PAPRICA project will be to provide high-quality clinical evidence for optimal treatment of deep caries lesions which is urgently needed. The project is very relevant within an area that has been known for suggestions of many treatments with the most invasive ones being the most popular ones. Only few previous studies define the depth of the carious lesion, data on well-defined lesions will clarify guidelines. Also, our design of this trial will attempt to reduce the risk of bias which is always critical when the investigator can't be blinded. In this respect the randomization will first be initiated after the 1 step of carious removal is completed. Results from a systematic review and a recent meta-analysis support stepwise excavation compared to complete excavation. However, firm evidence for one visit selective caries removal to soft dentine (previously defined as partial excavation) is still lacking. The project will for the first time investigate the caries treatment dilemma within a broader clinical context and thus aiming to reduce number of dental visits and to reduce acute pain. In the PAPRICA project a well-defined selective caries removal to soft dentine will be used as the lack of definitions are frequent in previously published clinical trials.
With this study we are aiming to 1) improve the treatment of deep caries by markedly reducing tooth-related pain, and consequently reduce the number of sick days due to toot-related pain; 2) reduce the number, complexity and duration of dental visits needed to treat deep caries; 3) provide data for an updated evidence-based treatment guideline for an improved health-care system.
Selection of participants: All patients at a participating clinical trial site are considered for participation. Patients will be eligible, if they comply with well-defined inclusion and exclusion criteria.
Statistical plan and data analysis: Sample size is 668 patients, based on the primary outcome 'pulp complications' among controls being 25%, and 15% in the experimental group, and combined with a type-I error of 5%; and a type-II error of 10%. Blinded interim analyses will be carried out. Statistical analysis of data from outcome measures - the gained frequencies of treatments leading to preservation of vital tooth without pain, apical pathology and no root filling will be examined using logistic regression analysis to assess the treatment effect adjusted for stratification variables. Odds ratio estimates will be used with 95% CI. Missing data will be handled using multiple imputations.
Randomization: Only one deep caries lesion per patient will be randomized. The trial will use block randomization with the following to stratifications variables: 1) Center; 2) Age (9-20 years/over 20 years). The randomization in the PAPRICA trial will be performed using an online system.
Blinding: The investigator performing the follow-up examination is not the same who performed the treatment. The analysis of the radiographs of the tooth at follow-up is carried out by an observer-committee being blinded for the intervention. The statistical analyses are carried out blinded. Patient blinding is not possible as the two intervention groups are performed as either a one-treatment procedure or a two-treatment procedure.
The patients who will be randomly allocated to 1-step partial caries removal will receive a treatment that normally is not practiced in relation to deep caries. However, there is a lack of randomised clinical trials investigating, whether partial caries removal has a positive prolonged effect with respect to maintained vital pulp and absence of apical pathology. The possible gain with the proposed treatment concept could be that the treatment of deep caries could be rationally performed without an extra treatment session and it may to a larger extent lead to an avoidance of exposure to the pulp. Patients who will be randomly allocated to 2-step partial caries removal receive a well-known treatment of deep caries. The intention is that we will gain data to reduce the risk of pulp exposures and thus the number of root canal treatments and possible reduce the number of days 'out-of' work due to tooth pain following an unnecessary invasive treatment of deep caries
Discontinuation and withdrawal: If a patient does not show-up for an appointment, attempts to make a re-appointment are carried out up to 3 times. It is important to stress that great effort should be carried out in order to find reasons for not attending an established appointment or if a patient wishes to withdraw from the trial. he investigators shall discontinue a participant from the trial intervention at any time, if: 1) There are signs of caries progression or failure of the restoration; 2) The participant is diagnosed with any of the exclusion criteria during the intervention period (except 'deep carious tooth has restoration in close contact with pulp'); 3) The participant experiences intolerable adverse reactions.
- Conditions
- Primary Dental Caries
- Being tested
- Resin restoration (1 step), Resin restoration (2 steps)
- Keywords
- Partial excavation, Deep dentin caries, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin restoration (1 step)Procedure or surgery
Permanent resin restoration is placed on top of the partial removed caries.
Resin restoration (2 steps)Procedure or surgery
A calcium hydroxide containing base material is used and a temporary glass-ionomer restoration is placed in the entire cavity. After 4-6 months the patients are recalled. The temporary restoration is removed and final excavation is carried out with hand excavators until firm but stained dentine remains. A permanent resin restoration is performed.
| Study group | Role | What they receive |
|---|---|---|
| Partial caries excavation (1 step) | Experimental | Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Local anaesthesia shall be used. as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine.
Intervention: A permanent resin restoration is placed on top of the remained caries. Receives: Procedure: Resin restoration (1 step) |
| Partial caries excavation (2 steps) | Active comparator | Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Before randomisation, the participants receive the first excavation procedure as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine.
Intervention: After randomisation, a calcium hydroxide containing base material is used and a temporary glass-ionomer restoration is placed in the entire cavity. After 4-6 months, the temporary restoration is removed, final excavation is carried out with hand excavators until firm but stained dentine remains, and a permanent resin restoration is placed. Receives: Procedure: Resin restoration (2 steps) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp complications
Pulp complications will be assessed using a registration scheme: no pulp vitality, based on negative thermal and/or electric pulp test; apical radiolucency as assessed by the blinded examiner based on radiograph; pulp exposure due to treatment of signs of pulpitis; endodontic treatment (root filling).
Measured: 3 years
Restoration quality
Quality of restorations will be assessed using af registration scheme: intact restoration: Intact restoration, Total lost of restoration; Partly Lost of restoration
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study startJan 2015
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dental CariesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Public Dental Health Care System, Denmark, Malmö University, Sweden, Halmstad County Hospital, Karolinska Institutet, Göteborg University, Lithuania
- Responsible party
- Principal investigator, Lars Bjørndal, University of Copenhagen
- Investigators
- Lars Bjørndal, Dr odont, PhD, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696498
- Sponsor's protocol ID
- THE PAPRICA TRIAL
- Acronym
- PAPRICA
- Status last verified
- Feb 2024
- First submitted
- 8 May 2017
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PArtial Excavation in One Procedure Versus Partial Excavation in Two Procedures of PRImary Deep CAries in Permanent Teeth - A Randomised, Multicenter Clinical Superiority Trial With Blinded Outcome Assessment
- ClinicalTrials.gov ID
- NCT03696498
- Acronym / sponsor ID
- PAPRICA / THE PAPRICA TRIAL
- Conditions
- Primary Dental Caries
- Keywords
- Partial excavation, Deep dentin caries, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Public Dental Health Care System, Denmark, Malmö University, Sweden, Halmstad County Hospital, Karolinska Institutet, Göteborg University, Lithuania
- Study start
- Jan 2015
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Oct 2018 (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.
Background: Deep caries is the most frequent reason for performing root canal treatments. Minimally invasive methods for the treatment of deep carious lesions might therefore be relevant to avoid pulp exposures and consequently to prevent root canal treatments. A 2 step carious removal approach has shown to avoid exposures. But we do not know whether a selective removal of carious tissue in well-defined deep caries lesions involving the pulpal quarter of the dentin can be successfully completed in 1 step.
Objectives: To investigate partial (selective) excavation by 1 vs 2 step in the treatment of deep caries in permanent teeth.
Design: RCT multinational superiority study with 2 parallel groups and blinded outcome assessment. The allocation sequence for partial (selective) carious removal vs 2 step stepwise carious removal (1:1) will be centralized and computer-generated, stratified for age and centre and concealed for the investigators.
Inclusion criteria: children (≥9 years) and adults with primary well-defined deep caries in a permanent tooth. The lesion should reach the pulpal ¼ of the dentin with presence of a radiodense zone on a bitewing.
Exclusion criteria: spontaneous and prolonged pain within the last 6 months; pain causing disturbed night sleep; negative pulp test; apical radiolucency; restoration in close contact with pulp; the patient has communication problems; no written informed consent.
Experimental intervention: 1-step selective carious removal to soft or firm dentine at central site , and peripheral non selective carious removal to hard dentin followed by a permanent resin restoration. Control intervention: Stepwise excavation (2- step, involving first step which is identical to the experimental intervention but a base material and a temporary glass-ionomer restoration is placed. The amount removed is as much as a proper restoration can be placed. After 4-6 months the patients are recalled and the temporary restoration is removed and final selective carious removal is completed until firm dentin remains followed by permanent resin restoration.
The primary outcome is to avoid pulp complication at the 1-year follow-up evaluating. The secondary outcomes are to arrest caries progression and sufficient restoration at the 1-year follow-up. All outcomes will further be assessed 3 years after inclusion.
Detailed description
Originality of the project: The originality of the PAPRICA project will be to provide high-quality clinical evidence for optimal treatment of deep caries lesions which is urgently needed. The project is very relevant within an area that has been known for suggestions of many treatments with the most invasive ones being the most popular ones. Only few previous studies define the depth of the carious lesion, data on well-defined lesions will clarify guidelines. Also, our design of this trial will attempt to reduce the risk of bias which is always critical when the investigator can't be blinded. In this respect the randomization will first be initiated after the 1 step of carious removal is completed. Results from a systematic review and a recent meta-analysis support stepwise excavation compared to complete excavation. However, firm evidence for one visit selective caries removal to soft dentine (previously defined as partial excavation) is still lacking. The project will for the first time investigate the caries treatment dilemma within a broader clinical context and thus aiming to reduce number of dental visits and to reduce acute pain. In the PAPRICA project a well-defined selective caries removal to soft dentine will be used as the lack of definitions are frequent in previously published clinical trials.
With this study we are aiming to 1) improve the treatment of deep caries by markedly reducing tooth-related pain, and consequently reduce the number of sick days due to toot-related pain; 2) reduce the number, complexity and duration of dental visits needed to treat deep caries; 3) provide data for an updated evidence-based treatment guideline for an improved health-care system.
Selection of participants: All patients at a participating clinical trial site are considered for participation. Patients will be eligible, if they comply with well-defined inclusion and exclusion criteria.
Statistical plan and data analysis: Sample size is 668 patients, based on the primary outcome 'pulp complications' among controls being 25%, and 15% in the experimental group, and combined with a type-I error of 5%; and a type-II error of 10%. Blinded interim analyses will be carried out. Statistical analysis of data from outcome measures - the gained frequencies of treatments leading to preservation of vital tooth without pain, apical pathology and no root filling will be examined using logistic regression analysis to assess the treatment effect adjusted for stratification variables. Odds ratio estimates will be used with 95% CI. Missing data will be handled using multiple imputations.
Randomization: Only one deep caries lesion per patient will be randomized. The trial will use block randomization with the following to stratifications variables: 1) Center; 2) Age (9-20 years/over 20 years). The randomization in the PAPRICA trial will be performed using an online system.
Blinding: The investigator performing the follow-up examination is not the same who performed the treatment. The analysis of the radiographs of the tooth at follow-up is carried out by an observer-committee being blinded for the intervention. The statistical analyses are carried out blinded. Patient blinding is not possible as the two intervention groups are performed as either a one-treatment procedure or a two-treatment procedure.
The patients who will be randomly allocated to 1-step partial caries removal will receive a treatment that normally is not practiced in relation to deep caries. However, there is a lack of randomised clinical trials investigating, whether partial caries removal has a positive prolonged effect with respect to maintained vital pulp and absence of apical pathology. The possible gain with the proposed treatment concept could be that the treatment of deep caries could be rationally performed without an extra treatment session and it may to a larger extent lead to an avoidance of exposure to the pulp. Patients who will be randomly allocated to 2-step partial caries removal receive a well-known treatment of deep caries. The intention is that we will gain data to reduce the risk of pulp exposures and thus the number of root canal treatments and possible reduce the number of days 'out-of' work due to tooth pain following an unnecessary invasive treatment of deep caries
Discontinuation and withdrawal: If a patient does not show-up for an appointment, attempts to make a re-appointment are carried out up to 3 times. It is important to stress that great effort should be carried out in order to find reasons for not attending an established appointment or if a patient wishes to withdraw from the trial. he investigators shall discontinue a participant from the trial intervention at any time, if: 1) There are signs of caries progression or failure of the restoration; 2) The participant is diagnosed with any of the exclusion criteria during the intervention period (except 'deep carious tooth has restoration in close contact with pulp'); 3) The participant experiences intolerable adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial caries excavation (1 step) | Experimental | Procedure: Resin restoration (1 step)Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Local anaesthesia shall be used. as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine. Intervention: A permanent resin restoration is placed on top of the remained caries. |
| Partial caries excavation (2 steps) | Active comparator | Procedure: Resin restoration (2 steps)Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Before randomisation, the participants receive the first excavation procedure as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine. Intervention: After randomisation, a calcium hydroxide containing base material is used and a temporary glass-ionomer restoration is placed in the entire cavity. After 4-6 months, the temporary restoration is removed, final excavation is carried out with hand excavators until firm but stained dentine remains, and a permanent resin restoration is placed. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adults and children >9 years.
- Primary coronal caries without pain in a permanent tooth (pain is accepted when evoked by a hot, cold, or sweet stimulus of short duration and disappears when the stimulus is removed).
- The radiograph shows caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine.
- No exposure of the pulp following the first excavation.
- Available for recall at 1 and 3 years.
Key exclusion criteria (5 listed)
- Actual deep carious tooth presenting spontaneous and/or prolonged pain within the last 6 months, or pain causing disturbed night sleep.
- Actual deep carious tooth with negative thermal and/or electrical pulp test.
- Radiograph shows apical or radicular radiolucency of the tooth.
- Deep carious tooth has restoration in close contact with pulp.
- No written informed consent.
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 |
|---|---|---|
| Resin restoration (1 step)Permanent resin restoration is placed on top of the partial removed caries. | Procedure or surgery | Partial caries excavation (1 step) |
| Resin restoration (2 steps)A calcium hydroxide containing base material is used and a temporary glass-ionomer restoration is placed in the entire cavity. After 4-6 months the patients are recalled. The temporary restoration is removed and final excavation is carried out with hand excavators until firm but stained dentine remains. A permanent resin restoration is performed. | Procedure or surgery | Partial caries excavation (2 steps) |
Primary outcome
Pulp complications
Time frame: 3 years
Pulp complications will be assessed using a registration scheme: no pulp vitality, based on negative thermal and/or electric pulp test; apical radiolucency as assessed by the blinded examiner based on radiograph; pulp exposure due to treatment of signs of pulpitis; endodontic treatment (root filling).
Restoration quality
Time frame: 3 years
Quality of restorations will be assessed using af registration scheme: intact restoration: Intact restoration, Total lost of restoration; Partly Lost of restoration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Yes
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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.
Lars Bjørndal, Dr odont, PhD study director
University of Copenhagen
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin restoration (1 step) and Resin restoration (2 steps) in people with Primary Dental Caries, run by University of Copenhagen at 11 sites in 4 countries.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark, Lithuania, Russia, Sweden. 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?
Results are not available in the source record.
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?
Pulp complications (time frame: 3 years). 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?
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 13 Feb 2024.