Manual; RotationNCT05619796
Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation
A study testing pulpectomy procedure, Post-operative Cone Beam Computed Tomography and Post-operative pain assessment in people with Manual; Rotation and Obturation, run by Tanta University at 1 site in Egypt.
Trial summary
Manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems. Little studies have been done to clinically evaluate the Kedo-S Square \& Fanta AF™ Baby rotary systems in relation to the quality of obturation… Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual; Rotation, Obturation, Post Operative Pain
- What is being tested?
- pulpectomy procedure, Post-operative Cone Beam Computed Tomography and Post-operative pain assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2022to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy cooperative children
- non-vital posterior teeth with sufficient coronal structure
- intact 2/3rd root structure
- no mobility or external pathological root resorption
Who cannot join
- Uncooperative children
- children with systemic illness
- non-restorable primary molars
- primary molars with sever mobility, or pathological root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Clinical and Radiographic Efficiency of Manual and Pediatric Rotary File Systems in Primary Root Canal Preparation
Manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems.
Little studies have been done to clinically evaluate the Kedo-S Square \& Fanta AF™ Baby rotary systems in relation to the quality of obturation, instrumentation time and postoperative pain in root canal preparation of primary molars using CBCT.
Read the detailed description
Biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . Conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation.
The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system.
The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology.
A good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. Another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.
- Conditions
- Manual; Rotation, Obturation, Post Operative Pain
- Being tested
- pulpectomy procedure, Post-operative Cone Beam Computed Tomography, Post-operative pain assessment
- Keywords
- Cone-beam computed tomography, kedo-S square, Fanta AF™ Baby
- Medical subject headings
- Bites and Stings, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpectomy procedureProcedure or surgery
single visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment.
Post-operative Cone Beam Computed TomographyRadiation
Also called Obturation Quality Assessment
post-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709).
The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique .
Post-operative pain assessmentOther
The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form.
| Study group | Role | What they receive |
|---|---|---|
| group 1: Kedo-S Square rotary files | Experimental | Primary root canals(n=20) were instrumented using rotary P1 Kedo-S Square files (Reeganz Dental Care Pvt. Ltd. India) at 300 rpm and 2.2N cm torque. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation. Receives: Procedure: pulpectomy procedure; Radiation: Post-operative Cone Beam Computed Tomography; Other: Post-operative pain assessment |
| group II: Fanta AFTM-Baby rotary system | Experimental | Primary root canals(n=20) were instrumented using Fanta AFTM-Baby rotary system (Shanghai Fanta Dental Materials, SUNGO Certification Company Limited, London, England) at 350 rpm and 2 N cm torque. Four files were used sequentially in the following order; open file #17/0.08, #20/0.04 yellow, #25/0.04 red and #30/0.04 blue. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation. Receives: Procedure: pulpectomy procedure; Radiation: Post-operative Cone Beam Computed Tomography; Other: Post-operative pain assessment |
| group III: manual K-files | Active comparator | Primary root canals(n=20) were instrumented using No.15 till 35 size manual K-files (Mani, Inc, Japan) using the quarter-turn-pull technique. Receives: Procedure: pulpectomy procedure; Radiation: Post-operative Cone Beam Computed Tomography; Other: Post-operative pain assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth
by evaluation of the obturation quality using immediate post-operative CBCT which is assessed by two trained pediatric dentists, blinded to instrumentation technique .
The quality of obturation was assessed by evaluating the length of the Metapex filling according to Coll and Sadrian criteria :
- Under filling (Score 1): Canal filled with metapex more than 2 mm short of the apex.
- Optimal filling (Score 2): Canal filling ending at the radiographic apex or up to 2 mm short of apex.
- Overfilling (Score 3): Any canal showing filling outside the root apex.
Measured: 2 days
Secondary outcomes (1)
postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems
using four-point pain intensity scale. This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain.
The parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure.
A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain.
To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals.
To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start4 Sep 2022
- Primary completion4 Mar 2023
- Study completion30 Jul 2023
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 Manual; RotationStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Model description
- A randomized, controlled prospective clinical study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619796
- Sponsor's protocol ID
- #R-PED-9-22-2
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barr ES, Kleier DJ, Barr NV. Use of nickel-titanium rotary files for root canal preparation in primary teeth. Pediatr Dent. 2000 Jan-Feb;22(1):77-8.
PubMed 10730297Jeevanandan G, Govindaraju L. Clinical comparison of Kedo-S paediatric rotary files vs manual instrumentation for root canal preparation in primary molars: a double blinded randomised clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):273-278. doi: 10.1007/s40368-018-0356-6. Epub 2018 Jul 12.
PubMed 30003514Mohamed RH, Abdelrahman AM, Sharaf AA. Evaluation of rotary file system (Kedo-S-Square) in root canal preparation of primary anterior teeth using cone beam computed tomography (CBCT)-in vitro study. BMC Oral Health. 2022 Jan 18;22(1):13. doi: 10.1186/s12903-021-02021-0.
PubMed 35042489Abd El Fatah YAM, Khattab NMA, Gomaa YF, Elheeny AAH. Cone-beam computed tomography analysis of primary root canals transportation and dentin loss after instrumentation with two-pediatric rotary files. BMC Oral Health. 2022 May 31;22(1):214. doi: 10.1186/s12903-022-02245-8.
PubMed 35641977Elheeny AAH, Abdelmotelb MA. Postoperative pain after primary molar pulpectomy using rotary or reciprocating single files: A superior, parallel, randomized clinical trial. Int J Paediatr Dent. 2022 Nov;32(6):819-827. doi: 10.1111/ipd.12959. Epub 2022 May 5.
PubMed 35152509
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical and Radiographic Efficiency of Manual and Pediatric Rotary File Systems in Primary Root Canal Preparation
- ClinicalTrials.gov ID
- NCT05619796
- Acronym / sponsor ID
- #R-PED-9-22-2
- Conditions
- Manual; Rotation, Obturation, Post Operative Pain
- Keywords
- Cone-beam computed tomography, kedo-S square, Fanta AF™ Baby
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 4 Sep 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 17 Nov 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.
Manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems.
Little studies have been done to clinically evaluate the Kedo-S Square \& Fanta AF™ Baby rotary systems in relation to the quality of obturation, instrumentation time and postoperative pain in root canal preparation of primary molars using CBCT.
Detailed description
Biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . Conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation.
The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system.
The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology.
A good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. Another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, controlled prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| group 1: Kedo-S Square rotary files | Experimental | Procedure: pulpectomy procedure, Radiation: Post-operative Cone Beam Computed Tomography, Other: Post-operative pain assessmentPrimary root canals(n=20) were instrumented using rotary P1 Kedo-S Square files (Reeganz Dental Care Pvt. Ltd. India) at 300 rpm and 2.2N cm torque. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation. |
| group II: Fanta AFTM-Baby rotary system | Experimental | Procedure: pulpectomy procedure, Radiation: Post-operative Cone Beam Computed Tomography, Other: Post-operative pain assessmentPrimary root canals(n=20) were instrumented using Fanta AFTM-Baby rotary system (Shanghai Fanta Dental Materials, SUNGO Certification Company Limited, London, England) at 350 rpm and 2 N cm torque. Four files were used sequentially in the following order; open file #17/0.08, #20/0.04 yellow, #25/0.04 red and #30/0.04 blue. The rotary files were used with an Endo-Mate DT endodontic motor (NSK, Tokyo, Japan) and EDTA gel 17% (Meta Biomed Co. Ltd, Chungbuk, Korea) was used before instrumentation. |
| group III: manual K-files | Active comparator | Procedure: pulpectomy procedure, Radiation: Post-operative Cone Beam Computed Tomography, Other: Post-operative pain assessmentPrimary root canals(n=20) were instrumented using No.15 till 35 size manual K-files (Mani, Inc, Japan) using the quarter-turn-pull technique. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- healthy cooperative children
- non-vital posterior teeth with sufficient coronal structure
- intact 2/3rd root structure
- no mobility or external pathological root resorption
Key exclusion criteria (4 listed)
- Uncooperative children
- children with systemic illness
- non-restorable primary molars
- primary molars with sever mobility, or 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 |
|---|---|---|
| pulpectomy proceduresingle visit pulpectomy was performed under strict aseptic conditions by a single operator. Peri-operative evaluation was done using intraoral digital senso. The teeth were anesthetized with 2% mepivacaine with 1:20,000 levonordefrin \& isolated using rubber dam. caries was removed using no. 330 round carbide burs in high-speed contra angle headpiece. Access opening was gained \& the roof of the pulp chamber was removed. Working length was determined by apex locator, then confirmed by periapical radiograph. Working length will be determined 1 mm shorter than apex. mechanical preparation was done using the tested files according to each group. Then, canals were irrigated with 1% sodium hypochlorite between each file followed by irrigation with normal saline. The root canals were dried using paper points \& root canals were filled with Metapex. Intermediate restorative material was placed, and the tooth was restored with a preformed stainless-steel crown in the same appointment. | Procedure or surgery | group 1: Kedo-S Square rotary files, group II: Fanta AFTM-Baby rotary system, group III: manual K-files |
| Post-operative Cone Beam Computed TomographyAlso: Obturation Quality Assessmentpost-operative CBCT image was taken after completing the procedure with fixed exposure parameters (120 Kv, 5mA and 0.125mm voxel size) using smallest field of view (8D, 8Hcm) to improve spatial resolution. The CBCT images were obtained by using 3D module of On Demand Dental software (version 1.0 (build 1.0.10.7462),× 64 Edition, copyright 2004-2017 Cybermed, Korea and license key 670094709). The Immediate post-operative CBCT was taken to evaluate the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique . | Radiation | group 1: Kedo-S Square rotary files, group II: Fanta AFTM-Baby rotary system, group III: manual K-files |
| Post-operative pain assessmentThe parents of the children were given a questionnaire to record the intensity of postoperative pain at six, twelve, twenty-four and forty-eight hours after the pulpectomy procedure. A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain. The four-point pain intensity scale was used to record postoperative pain (figure 5). This scale categorizes pain as follows: (1) no pain; (2) slight pain; (3) moderate pain; and (4) severe pain. To ensure standardization, the same parent was asked to record the child's pain intensity at all time intervals. To reduce the possibility of the parents failing to record the pain at a given time, the investigator also recorded findings via telephonic conversation with the parents. The children returned to the department two days after the pulpectomy procedure with their completed questionnaire form. | Other | group 1: Kedo-S Square rotary files, group II: Fanta AFTM-Baby rotary system, group III: manual K-files |
Primary outcome
Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth
Time frame: 2 days
by evaluation of the obturation quality using immediate post-operative CBCT which is assessed by two trained pediatric dentists, blinded to instrumentation technique . The quality of obturation was assessed by evaluating the length of the Metapex filling according to Coll and Sadrian criteria : * Under filling (Score 1): Canal filled with metapex more than 2 mm short of the apex. * Optimal filling (Score 2): Canal filling ending at the radiographic apex or up to 2 mm short of apex. * Overfilling (Score 3): Any canal showing filling outside the root apex.
1 secondary outcome
postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 10730297Barr ES, Kleier DJ, Barr NV. Use of nickel-titanium rotary files for root canal preparation in primary teeth. Pediatr Dent. 2000 Jan-Feb;22(1):77-8.
- Background: PubMed 30003514Jeevanandan G, Govindaraju L. Clinical comparison of Kedo-S paediatric rotary files vs manual instrumentation for root canal preparation in primary molars: a double blinded randomised clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):273-278. doi: 10.1007/s40368-018-0356-6. Epub 2018 Jul 12.
- Background: PubMed 35042489Mohamed RH, Abdelrahman AM, Sharaf AA. Evaluation of rotary file system (Kedo-S-Square) in root canal preparation of primary anterior teeth using cone beam computed tomography (CBCT)-in vitro study. BMC Oral Health. 2022 Jan 18;22(1):13. doi: 10.1186/s12903-021-02021-0.
- Background: PubMed 35641977Abd El Fatah YAM, Khattab NMA, Gomaa YF, Elheeny AAH. Cone-beam computed tomography analysis of primary root canals transportation and dentin loss after instrumentation with two-pediatric rotary files. BMC Oral Health. 2022 May 31;22(1):214. doi: 10.1186/s12903-022-02245-8.
- Background: PubMed 35152509Elheeny AAH, Abdelmotelb MA. Postoperative pain after primary molar pulpectomy using rotary or reciprocating single files: A superior, parallel, randomized clinical trial. Int J Paediatr Dent. 2022 Nov;32(6):819-827. doi: 10.1111/ipd.12959. Epub 2022 May 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulpectomy procedure, Post-operative Cone Beam Computed Tomography and Post-operative pain assessment in people with Manual; Rotation and Obturation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth (time frame: 2 days). 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 NCT05619796, 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 7 Dec 2023.