Pulp NecrosisNCT04313010
Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis
A study testing PRF and BC in people with Pulp Necrosis, run by Southern Medical University, China at 3 sites in China.
Trial summary
This study is to evaluate the effectiveness of regenerative endodontics therapy in single-rooted permanent teeth with pulp necrosis，and compare the clinical efficacy of platelet rich fibrin (PRF) and blood clot (BC) as scaffolds. Read more about this study
- Who is it for?
- Ages 10 to 59 years
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- PRF and BC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 3 sitesChina
- Study dates
- 16 Mar 2020to 30 Jun 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 10 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Intended to participate with this study, and provide informed assent/consent.
- Aged 10 and 59 years.
- At least one mature permanent teeth diagnosed as pulp necrosis with or without periapical lesion, and CBCT showed the teeth has single root and single root canal.
Who cannot join
- Allergic to any medications or materials necessary to complete the procedures.
- The teeth with severe coronal defect, of which pulp space is needed for post/core final restoration.
- Non-restorable teeth.
- The teeth with root fracture or vertical root fractures.
- Concurrent signs of other pathological root resorption.
- Patients with periodontitis.
Show all 13Show fewer
- Patients with dental dysplasia or other oral genetic disorders.
- Women who are pregnant or lactating, or women who plan to become pregnant in the subsequent 2 years.
- Patients with dental phobia.
- Patients with mental disorders.
- Patients with a history of systemic diseases that may alter immune function.
- Patients with medical conditions and/or receiving medications that would affect patients' body's ability of healing or blood clotting.
- Participants who are participating in or had participated in other clinical studies within the prior 3 months.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
Wanghong Zhao, Doctor, 0086-020-62787680, zhaowh@smu.edu.cn
- Recruiting
Stomatological Hospital, Southern Medical University
Guangzhou
Jun Wen, Doctor, drwenjun@sina.com
- Recruiting
Shenzhen Hospital, Southern Medical University
Shenzhen
Wen Sui, Doctor, wens27@163.com
About this study
Official title: Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis: a Multicenter Randomized Controlled Clinical Trial.
This study is to evaluate the effectiveness of regenerative endodontics therapy in single-rooted permanent teeth with pulp necrosis，and compare the clinical efficacy of platelet rich fibrin (PRF) and blood clot (BC) as scaffolds.
Read the detailed description
Regenerative endodontics therapy (RET), based on the principles of tissue engineering, manipulates stem cells, scaffold, and bioactive growth factors to achieve the functional reconstruction of pulp tissue. RET has been recommended strongly as an alternative in treating immature permanent teeth with necrotic pulp in recent years, while root canal therapy (RCT) has been extensively applied in the treatment of mature permanent teeth with necrotic pulp. RCT contains the chemomechanical preparation of the infected root canals to eliminate the microorganisms, and root canal obturation with filling materials to reduce and prevent microbial contamination in root canal system. However, the root canal filling materials, such as Gutta-percha, are inert materials which fail to recover the physiological function of the pulp. As RET has been proved curative for immature permanent teeth diagnosed with pulp necrosis, doctors and researchers try to extend its application in the mature ones. Encouragingly, several RET cases for mature teeth reported in the literature have shown positive clinical outcomes. However, it still lacks long-term and well-designed randomized clinical trial with large sample size and following standardized protocol, hence this study is conducted to make up for it to achieve high-level evidence.
In the process of RET, the scaffold can provide nutrition and space, which are essential for the proliferation and differentiation of stem cells. Therefore, it is a crucial step to select a high-quality material as the scaffold. In many studies of RET procedures, blood clot (BC), generated by provoking apical bleeding into the root canal, is regarded as a scaffold. Nevertheless, it remains a common problem that operators may fail to induce apical bleeding or achieve adequate blood volume. Recent studies suggest that patelet rich fibrin (PRF), the second-generation platelet concentrate, can provide a fibrin network full of cytokines and growth factors, which may improve the desired biological outcome. Accordingly, we assumed that PRF could improve the curative effect for mature teeth in RET. The purpose of this study is to compare the clinical efficacy of PRF and BC as scaffolds in RET for the mature permanent tooth with pulp necrosis.
- Conditions
- Pulp Necrosis
- Being tested
- PRF, BC
- Keywords
- Pulp Necrosis, Regenerative Endodontics Therapy, Platelet Rich Fibrin
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFOther
A sample of whole venous blood was drawn from the patient's forearm. The blood sample was transferred into a tube without anticoagulant and centrifuged immediately using a centrifuge.
BCOther
According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal.
| Study group | Role | What they receive |
|---|---|---|
| Regenerative endodontics therapy with PRF | Experimental | In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. Only the apex 1/3 of the root canal need to be filled with blood. PRF was injected into the root canal to a level below the CEJ, then wait for 10-15min to coagulate. Receives: Other: PRF |
| Regenerative endodontics therapy with BC | Active comparator | In the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. The adequate blood need to be full with canal space and below the CEJ, then wait for 10-15min to coagulate. Receives: Other: BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of regenerative endodontics therapy
Success: Defined as symptoms, clinical and radiographic assessment of the teeth. The teeth with RET were asymptomatic; Clinical examination showed absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.). Radiographic assessment showed the reduction and/or absence of periapical radiolucency.
Measured: 24 months
Secondary outcomes (2)
Change in pulp vitality
Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in teeth treated with RET.
Measured: 1、3、6、12、18、24 months
Adverse events
Such as discoloration, reinfection, root resorption and so on.
Measured: 1、3、6、12、18、24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start16 Mar 2020 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulp NecrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University
- Responsible party
- Principal investigator, Wanghong Zhao, Nanfang Hospital, Southern Medical University
- Investigators
- Wanghong Zhao, Doctor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313010
- Sponsor's protocol ID
- LC2019ZD023
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim SG, Malek M, Sigurdsson A, Lin LM, Kahler B. Regenerative endodontics: a comprehensive review. Int Endod J. 2018 Dec;51(12):1367-1388. doi: 10.1111/iej.12954. Epub 2018 Jun 11.
PubMed 29777616Diogenes A, Ruparel NB, Shiloah Y, Hargreaves KM. Regenerative endodontics: A way forward. J Am Dent Assoc. 2016 May;147(5):372-80. doi: 10.1016/j.adaj.2016.01.009. Epub 2016 Mar 24.
PubMed 27017182Adnan S, Ullah R. Top-cited Articles in Regenerative Endodontics: A Bibliometric Analysis. J Endod. 2018 Nov;44(11):1650-1664. doi: 10.1016/j.joen.2018.07.015. Epub 2018 Sep 19.
PubMed 30243658Saoud TM, Sigurdsson A, Rosenberg PA, Lin LM, Ricucci D. Treatment of a large cystlike inflammatory periapical lesion associated with mature necrotic teeth using regenerative endodontic therapy. J Endod. 2014 Dec;40(12):2081-6. doi: 10.1016/j.joen.2014.07.027. Epub 2014 Oct 5.
PubMed 25292168Saoud TM, Martin G, Chen YH, Chen KL, Chen CA, Songtrakul K, Malek M, Sigurdsson A, Lin LM. Treatment of Mature Permanent Teeth with Necrotic Pulps and Apical Periodontitis Using Regenerative Endodontic Procedures: A Case Series. J Endod. 2016 Jan;42(1):57-65. doi: 10.1016/j.joen.2015.09.015. Epub 2015 Oct 31.
PubMed 26525552Paryani K, Kim SG. Regenerative endodontic treatment of permanent teeth after completion of root development: a report of 2 cases. J Endod. 2013 Jul;39(7):929-34. doi: 10.1016/j.joen.2013.04.029. Epub 2013 May 14.
PubMed 23791266Nageh M, Ahmed GM, El-Baz AA. Assessment of Regaining Pulp Sensibility in Mature Necrotic Teeth Using a Modified Revascularization Technique with Platelet-rich Fibrin: A Clinical Study. J Endod. 2018 Oct;44(10):1526-1533. doi: 10.1016/j.joen.2018.06.014. Epub 2018 Aug 31.
PubMed 30174103Galler KM, Krastl G, Simon S, Van Gorp G, Meschi N, Vahedi B, Lambrechts P. European Society of Endodontology position statement: Revitalization procedures. Int Endod J. 2016 Aug;49(8):717-23. doi: 10.1111/iej.12629. Epub 2016 Apr 23.
PubMed 26990236Ulusoy AT, Turedi I, Cimen M, Cehreli ZC. Evaluation of Blood Clot, Platelet-rich Plasma, Platelet-rich Fibrin, and Platelet Pellet as Scaffolds in Regenerative Endodontic Treatment: A Prospective Randomized Trial. J Endod. 2019 May;45(5):560-566. doi: 10.1016/j.joen.2019.02.002. Epub 2019 Mar 30.
PubMed 30935618Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.
PubMed 30003342Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
PubMed 28154995Liang Y, Ma R, Chen L, Dai X, Zuo S, Jiang W, Hu N, Deng Z, Zhao W. Efficacy of i-PRF in regenerative endodontics therapy for mature permanent teeth with pulp necrosis: study protocol for a multicentre randomised controlled trial. Trials. 2021 Jul 6;22(1):436. doi: 10.1186/s13063-021-05401-7.
PubMed 34229752
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis: a Multicenter Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04313010
- Acronym / sponsor ID
- LC2019ZD023
- Conditions
- Pulp Necrosis
- Keywords
- Pulp Necrosis, Regenerative Endodontics Therapy, Platelet Rich Fibrin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University
- Study start
- 16 Mar 2020 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the effectiveness of regenerative endodontics therapy in single-rooted permanent teeth with pulp necrosis，and compare the clinical efficacy of platelet rich fibrin (PRF) and blood clot (BC) as scaffolds.
Detailed description
Regenerative endodontics therapy (RET), based on the principles of tissue engineering, manipulates stem cells, scaffold, and bioactive growth factors to achieve the functional reconstruction of pulp tissue. RET has been recommended strongly as an alternative in treating immature permanent teeth with necrotic pulp in recent years, while root canal therapy (RCT) has been extensively applied in the treatment of mature permanent teeth with necrotic pulp. RCT contains the chemomechanical preparation of the infected root canals to eliminate the microorganisms, and root canal obturation with filling materials to reduce and prevent microbial contamination in root canal system. However, the root canal filling materials, such as Gutta-percha, are inert materials which fail to recover the physiological function of the pulp. As RET has been proved curative for immature permanent teeth diagnosed with pulp necrosis, doctors and researchers try to extend its application in the mature ones. Encouragingly, several RET cases for mature teeth reported in the literature have shown positive clinical outcomes. However, it still lacks long-term and well-designed randomized clinical trial with large sample size and following standardized protocol, hence this study is conducted to make up for it to achieve high-level evidence.
In the process of RET, the scaffold can provide nutrition and space, which are essential for the proliferation and differentiation of stem cells. Therefore, it is a crucial step to select a high-quality material as the scaffold. In many studies of RET procedures, blood clot (BC), generated by provoking apical bleeding into the root canal, is regarded as a scaffold. Nevertheless, it remains a common problem that operators may fail to induce apical bleeding or achieve adequate blood volume. Recent studies suggest that patelet rich fibrin (PRF), the second-generation platelet concentrate, can provide a fibrin network full of cytokines and growth factors, which may improve the desired biological outcome. Accordingly, we assumed that PRF could improve the curative effect for mature teeth in RET. The purpose of this study is to compare the clinical efficacy of PRF and BC as scaffolds in RET for the mature permanent tooth with pulp necrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenerative endodontics therapy with PRF | Experimental | Other: PRFIn the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. Only the apex 1/3 of the root canal need to be filled with blood. PRF was injected into the root canal to a level below the CEJ, then wait for 10-15min to coagulate. |
| Regenerative endodontics therapy with BC | Active comparator | Other: BCIn the procedures of regenerative endodontics therapy, K-files were intentionally used to violate the periapical tissues via overinstrumentation up to 2-3mm past the apical foramen to induce bleeding. The adequate blood need to be full with canal space and below the CEJ, then wait for 10-15min to coagulate. |
Who may qualify
- Ages
- 10 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Intended to participate with this study, and provide informed assent/consent.
- Aged 10 and 59 years.
- At least one mature permanent teeth diagnosed as pulp necrosis with or without periapical lesion, and CBCT showed the teeth has single root and single root canal.
Key exclusion criteria (13 listed)
- Allergic to any medications or materials necessary to complete the procedures.
- The teeth with severe coronal defect, of which pulp space is needed for post/core final restoration.
- Non-restorable teeth.
- The teeth with root fracture or vertical root fractures.
- Concurrent signs of other pathological root resorption.
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 |
|---|---|---|
| PRFA sample of whole venous blood was drawn from the patient's forearm. The blood sample was transferred into a tube without anticoagulant and centrifuged immediately using a centrifuge. | Other | Regenerative endodontics therapy with PRF |
| BCAccording to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal. | Other | Regenerative endodontics therapy with BC |
Primary outcome
Success of regenerative endodontics therapy
Time frame: 24 months
Success: Defined as symptoms, clinical and radiographic assessment of the teeth. The teeth with RET were asymptomatic; Clinical examination showed absence of clinical signs of pain and soft tissue pathology (e.g. abscess, sinus tract etc.). Radiographic assessment showed the reduction and/or absence of periapical radiolucency.
2 secondary outcomes
Change in pulp vitality
Time frame: 1、3、6、12、18、24 months
Adverse events
Time frame: 1、3、6、12、18、24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Background: PubMed 29777616Kim SG, Malek M, Sigurdsson A, Lin LM, Kahler B. Regenerative endodontics: a comprehensive review. Int Endod J. 2018 Dec;51(12):1367-1388. doi: 10.1111/iej.12954. Epub 2018 Jun 11.
- Background: PubMed 27017182Diogenes A, Ruparel NB, Shiloah Y, Hargreaves KM. Regenerative endodontics: A way forward. J Am Dent Assoc. 2016 May;147(5):372-80. doi: 10.1016/j.adaj.2016.01.009. Epub 2016 Mar 24.
- Background: PubMed 30243658Adnan S, Ullah R. Top-cited Articles in Regenerative Endodontics: A Bibliometric Analysis. J Endod. 2018 Nov;44(11):1650-1664. doi: 10.1016/j.joen.2018.07.015. Epub 2018 Sep 19.
- Background: PubMed 25292168Saoud TM, Sigurdsson A, Rosenberg PA, Lin LM, Ricucci D. Treatment of a large cystlike inflammatory periapical lesion associated with mature necrotic teeth using regenerative endodontic therapy. J Endod. 2014 Dec;40(12):2081-6. doi: 10.1016/j.joen.2014.07.027. Epub 2014 Oct 5.
- Background: PubMed 26525552Saoud TM, Martin G, Chen YH, Chen KL, Chen CA, Songtrakul K, Malek M, Sigurdsson A, Lin LM. Treatment of Mature Permanent Teeth with Necrotic Pulps and Apical Periodontitis Using Regenerative Endodontic Procedures: A Case Series. J Endod. 2016 Jan;42(1):57-65. doi: 10.1016/j.joen.2015.09.015. Epub 2015 Oct 31.
- Background: PubMed 23791266Paryani K, Kim SG. Regenerative endodontic treatment of permanent teeth after completion of root development: a report of 2 cases. J Endod. 2013 Jul;39(7):929-34. doi: 10.1016/j.joen.2013.04.029. Epub 2013 May 14.
- Background: PubMed 30174103Nageh M, Ahmed GM, El-Baz AA. Assessment of Regaining Pulp Sensibility in Mature Necrotic Teeth Using a Modified Revascularization Technique with Platelet-rich Fibrin: A Clinical Study. J Endod. 2018 Oct;44(10):1526-1533. doi: 10.1016/j.joen.2018.06.014. Epub 2018 Aug 31.
- Background: PubMed 26990236Galler KM, Krastl G, Simon S, Van Gorp G, Meschi N, Vahedi B, Lambrechts P. European Society of Endodontology position statement: Revitalization procedures. Int Endod J. 2016 Aug;49(8):717-23. doi: 10.1111/iej.12629. Epub 2016 Apr 23.
- Background: PubMed 30935618Ulusoy AT, Turedi I, Cimen M, Cehreli ZC. Evaluation of Blood Clot, Platelet-rich Plasma, Platelet-rich Fibrin, and Platelet Pellet as Scaffolds in Regenerative Endodontic Treatment: A Prospective Randomized Trial. J Endod. 2019 May;45(5):560-566. doi: 10.1016/j.joen.2019.02.002. Epub 2019 Mar 30.
- Background: PubMed 30003342Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.
- Background: PubMed 28154995Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
- Derived from this study: PubMed 34229752Liang Y, Ma R, Chen L, Dai X, Zuo S, Jiang W, Hu N, Deng Z, Zhao W. Efficacy of i-PRF in regenerative endodontics therapy for mature permanent teeth with pulp necrosis: study protocol for a multicentre randomised controlled trial. Trials. 2021 Jul 6;22(1):436. doi: 10.1186/s13063-021-05401-7.
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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.
Wanghong Zhao, Doctor study chair
Nanfang Hospital, Southern Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF and BC in people with Pulp Necrosis, run by Southern Medical University, China at 3 sites in China.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Contact Wanghong Zhao, Doctor (0086-020-62787680, zhaowh@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of regenerative endodontics therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313010, which also lists 12 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 23 Mar 2020.