Apical PeriodontitisNCT05847647
Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Healing After Periradicular Surgery
A study testing Retrograde Filling Group, Retrograde Filling+L-PRF Group and (Orthograde Filling Group / OG Group). in people with Apical Periodontitis and Periapical Lesion, run by Seyda Ersahan, DDS, PhD at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of two different periapical surgery methods ("curettage+apical resection" and "curettage") on the bone regeneration and clinical healing without applying any material or with applying leukocyte and platelet rich fibrin (L-PRF) to the periradicular intraosseous defect in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Periapical Lesion
- What is being tested?
- Retrograde Filling Group, Retrograde Filling+L-PRF Group and (Orthograde Filling Group / OG Group).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2022to 2 Sep 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old.
- systemic status is ASA I.
- No history of allergy to local anesthetics and drugs to be used. D. Absence of a systemic disease or drug use that may adversely affect wound healing and contraindicate oral surgical procedures (radiotherapy, chemotherapy, corticosteroid use, antiplatelet or anticoagulant drug use, connective tissue diseases, vascular diseases, blood dyscrasia, liver diseases, uncontrolled diabetes, etc.).
- to. Not smoking more than 10 cigarettes per day. f. Having a single rooted tooth of endodontic origin, with a periradicular lesion larger than 5 mm and smaller than 12 mm in diameter detected on periapical radiograph (chronic apical periodontitis), re-canal treatment planned and thought to be unsuccessful with re-canal treatment alone.
Who cannot join
- Having ASA II-III-IV.
- Having a history of allergy to local anesthetics and drugs to be used.
- Presence of a systemic disease or drug use that may adversely affect postoperative wound healing and periodontal health.
- Being pregnant or lactating. to. Not using antiplatelet or anticoagulant drugs and having blood dyscrasias f. Smoking more than 10 cigarettes per day. g. Vertical root fracture, perforation in the furcation region, endo-perio lesion and more than 5 mm periodontal bone loss in the involved tooth.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Dentistry
Istanbul
About this study
Official title: Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Clinical and Radiographic Healing After Periradicular Surgery: Randomized Controlled Clinical Trial.
The aim of this study is to evaluate the effect of two different periapical surgery methods ("curettage+apical resection" and "curettage") on the bone regeneration and clinical healing without applying any material or with applying leukocyte and platelet rich fibrin (L-PRF) to the periradicular intraosseous defect in the treatment of the teeth with large periapical lesions by following the patients for 12 months.
Read the detailed description
Materials and Methods:
Apical periodontitis is a local response of the bone around the root tip of the tooth to necrosis of the pulp tissue. In the treatment of apical periodontitis, it is primarily aimed to remove the pathogenic microorganisms responsible for the infection with root canal treatment. The success of root canal treatment depends on the complete repair and regeneration of periapical tissues, and most of the periapical lesions heal satisfactorily after root canal treatment, but there are cases where infection and persistent symptoms persist despite root canal treatment. In these cases, periapical surgery with endodontic retreatment is required to eliminate pathological tissues, eliminate the source of irritation and support the healing process. For this purpose, 2 different periapical surgical methods are performed. In the first method, which is a more radical technique, the tip of the root of the related tooth responsible for apical periodontitis is resected (apicectomy) after curettage of the bone defect area. In the second method, in which the tooth tissue is preserved with a more conservative approach, only the defect area is curetted without root tip resection. Different results regarding the clinical success of these two methods have been reported in the literature.
In many studies, apicectomy is accepted as principal part of periapical surgical procedures and a prerequisite for the success of treatment but, roots that have already weakened and thinned due to periodontitis become more prone to fracture. In addition, especially in cases where the ratio between crown and root length is impaired, the stability of the restoration is adversely affected and the stability of the tooth in the socket may become questionable in the long term. In the literature, there are only a few case reports and a clinical study evaluating the clinical success of periapical surgery performed with periapical curettage without apicectomy following endodontic retreatment.
In recent years, many studies have been carried out to increase the success of apical surgery by accelerating and increasing the formation of new bone in the defect area with regenerative applications. Leukocyte and platelet-rich fibrin (L-PRF) is a second-generation platelet concentrate that forms an organized fibrin network in which platelets and leukocytes are trapped. In the few studies in the literature regarding the use of L-PRF alone without combining with a graft, in periapical surgery, apical surgery has been performed with root tip resection. In the literature, there is only one case series evaluating the effect of L-PRF application on periapical intraosseous defect after apical curettage without apicectomy on clinical and radiological healing.
In the treatment of apical periodontitis cases whith persistant symptoms and infection despite root canal treatment; more successful long-term results are aimed to be achieved by curettage of the periapical lesion and placement of L-PRF in the intraosseous defect after endodontic retreatment providing acceleration of apical bone regeneration, reducing clinical symptoms, and preserving the tooth root with a more conservative approach.
60 volunteer patients over the age of 18 who applied to Istanbul Medipol University Faculty of Dentistry, Department of Endodontics and were diagnosed with refractory chronic apical periodontitis due to a periapical lesion of endodontic origin that did not respond to root canal treatment, will be included in the study, regardless of gender. Periapical surgery will be applied in all patients following the endodontic retreatment.
Patients will be randomly divided into 4 groups of 15 patients in each group:
- Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect (Retrograde Filling Group / RG Group).
- Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect (Retrograde Filling+L-PRF Group / RG+L-PRF Group).
- Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect (Orthograde Filling Group / OG Group).
- Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect (Orthograde Filling+L-PRF Group / OG+L-PRF Group).
All surgical operations will be performed by the same surgeon, and all endodontic treatments will be performed by the same endodontist. Patients will be called for control for clinical and radiographic evaluation at 1. week and 1., 3., 6., 9., and 12. months. The PAI (Periapical index) score and the dimensions of the periapical radiolucency will be evaluated on the periapical radiographs taken at the control sessions. In addition, pain, swelling, tooth mobility, sensitivity to percussion, sensitivity of palpation and presence of fistula will be evaluated. Patients will be given forms including a 10-unit Numeric Rating Scale (NRS), and they will be asked to mark the pain they feel every day for 1 week postoperatively and to record the number of painkillers they use.
- Conditions
- Apical Periodontitis, Periapical Lesion
- Being tested
- Retrograde Filling Group, Retrograde Filling+L-PRF Group, (Orthograde Filling Group / OG Group)., (Orthograde Filling+L-PRF Group
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Filling GroupOther
Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect.
Retrograde Filling+L-PRF GroupOther
- Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect (
(Orthograde Filling Group / OG Group).Other
- Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect
(Orthograde Filling+L-PRF GroupOther
- Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect
| Study group | Role | What they receive |
|---|---|---|
| 1. group: Retrograde Filling Group / RG Group | Experimental | Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect Receives: Other: Retrograde Filling Group |
| 2. Group: Retrograde Filling+L-PRF Group / RG+L-PRF Group | Experimental | Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect. Receives: Other: Retrograde Filling+L-PRF Group |
| 3. Group: Orthograde Filling Group / OG Group | Experimental | Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect. Receives: Other: (Orthograde Filling Group / OG Group). |
| 4. Group: Orthograde Filling+L-PRF Group / OG+L-PRF Group | Experimental | Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect. Receives: Other: (Orthograde Filling+L-PRF Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical lesion healing
Periapical index score and the dimensions of the periapical radiolucency will be evaluated on the periapical radiographs taken at the control sessions. In addition, pain, swelling, tooth mobility, sensitivity to percussion, sensitivity of palpation and presence of fistula will be evaluated.
The PAI is a basic radiographic method of interpretation consisting of a scale from 1 to 5. It was first described by Ørstavik et al in 1986 (14). For each subject, the periapical tissue was assessed radiographically using the PAI as follows:
- PAI 1: normal periapical structure
- PAI 2: small changes in the bone structure not pathognomonic of apical periodontitis
- PAI 3: changes in the bone structure with mineral loss characteristic of apical periodontitis
- PAI 4: well-defined apical radiolucency characteristic of apical periodontitis
- PAI 5: severe periodontitis with exacerbating features and bone expansion
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Feb 2022
- Primary completion2 Mar 2023
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies 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, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seyda Ersahan, DDS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital
- Investigators
- SEYDA ERSAHAN, Assoc.Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847647
- Sponsor's protocol ID
- periradicular surgery
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gulsever S, Ersahan S, Hepsenoglu YE, Tekin A. Apicoectomy versus apical curettage in combination with or without L-PRF application: a randomized clinical trial. Sci Rep. 2025 Mar 8;15(1):8121. doi: 10.1038/s41598-025-92787-y.
PubMed 40057596
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Leukocyte and Platelet-rich Fibrin on Clinical and Radiographic Healing After Periradicular Surgery: Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05847647
- Acronym / sponsor ID
- periradicular surgery
- Conditions
- Apical Periodontitis, Periapical Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seyda Ersahan, DDS, PhDUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 6 May 2023 (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 aim of this study is to evaluate the effect of two different periapical surgery methods ("curettage+apical resection" and "curettage") on the bone regeneration and clinical healing without applying any material or with applying leukocyte and platelet rich fibrin (L-PRF) to the periradicular intraosseous defect in the treatment of the teeth with large periapical lesions by following the patients for 12 months.
Detailed description
Materials and Methods:
Apical periodontitis is a local response of the bone around the root tip of the tooth to necrosis of the pulp tissue. In the treatment of apical periodontitis, it is primarily aimed to remove the pathogenic microorganisms responsible for the infection with root canal treatment. The success of root canal treatment depends on the complete repair and regeneration of periapical tissues, and most of the periapical lesions heal satisfactorily after root canal treatment, but there are cases where infection and persistent symptoms persist despite root canal treatment. In these cases, periapical surgery with endodontic retreatment is required to eliminate pathological tissues, eliminate the source of irritation and support the healing process. For this purpose, 2 different periapical surgical methods are performed. In the first method, which is a more radical technique, the tip of the root of the related tooth responsible for apical periodontitis is resected (apicectomy) after curettage of the bone defect area. In the second method, in which the tooth tissue is preserved with a more conservative approach, only the defect area is curetted without root tip resection. Different results regarding the clinical success of these two methods have been reported in the literature.
In many studies, apicectomy is accepted as principal part of periapical surgical procedures and a prerequisite for the success of treatment but, roots that have already weakened and thinned due to periodontitis become more prone to fracture. In addition, especially in cases where the ratio between crown and root length is impaired, the stability of the restoration is adversely affected and the stability of the tooth in the socket may become questionable in the long term. In the literature, there are only a few case reports and a clinical study evaluating the clinical success of periapical surgery performed with periapical curettage without apicectomy following endodontic retreatment.
In recent years, many studies have been carried out to increase the success of apical surgery by accelerating and increasing the formation of new bone in the defect area with regenerative applications. Leukocyte and platelet-rich fibrin (L-PRF) is a second-generation platelet concentrate that forms an organized fibrin network in which platelets and leukocytes are trapped. In the few studies in the literature regarding the use of L-PRF alone without combining with a graft, in periapical surgery, apical surgery has been performed with root tip resection. In the literature, there is only one case series evaluating the effect of L-PRF application on periapical intraosseous defect after apical curettage without apicectomy on clinical and radiological healing.
In the treatment of apical periodontitis cases whith persistant symptoms and infection despite root canal treatment; more successful long-term results are aimed to be achieved by curettage of the periapical lesion and placement of L-PRF in the intraosseous defect after endodontic retreatment providing acceleration of apical bone regeneration, reducing clinical symptoms, and preserving the tooth root with a more conservative approach.
60 volunteer patients over the age of 18 who applied to Istanbul Medipol University Faculty of Dentistry, Department of Endodontics and were diagnosed with refractory chronic apical periodontitis due to a periapical lesion of endodontic origin that did not respond to root canal treatment, will be included in the study, regardless of gender. Periapical surgery will be applied in all patients following the endodontic retreatment.
Patients will be randomly divided into 4 groups of 15 patients in each group:
- Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect (Retrograde Filling Group / RG Group).
- Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect (Retrograde Filling+L-PRF Group / RG+L-PRF Group).
- Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect (Orthograde Filling Group / OG Group).
- Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect (Orthograde Filling+L-PRF Group / OG+L-PRF Group).
All surgical operations will be performed by the same surgeon, and all endodontic treatments will be performed by the same endodontist. Patients will be called for control for clinical and radiographic evaluation at 1. week and 1., 3., 6., 9., and 12. months. The PAI (Periapical index) score and the dimensions of the periapical radiolucency will be evaluated on the periapical radiographs taken at the control sessions. In addition, pain, swelling, tooth mobility, sensitivity to percussion, sensitivity of palpation and presence of fistula will be evaluated. Patients will be given forms including a 10-unit Numeric Rating Scale (NRS), and they will be asked to mark the pain they feel every day for 1 week postoperatively and to record the number of painkillers they use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. group: Retrograde Filling Group / RG Group | Experimental | Other: Retrograde Filling GroupSurgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect |
| 2. Group: Retrograde Filling+L-PRF Group / RG+L-PRF Group | Experimental | Other: Retrograde Filling+L-PRF GroupSurgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect. |
| 3. Group: Orthograde Filling Group / OG Group | Experimental | Other: (Orthograde Filling Group / OG Group).Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect. |
| 4. Group: Orthograde Filling+L-PRF Group / OG+L-PRF Group | Experimental | Other: (Orthograde Filling+L-PRF GroupSurgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years old.
- systemic status is ASA I.
- No history of allergy to local anesthetics and drugs to be used. D. Absence of a systemic disease or drug use that may adversely affect wound healing and contraindicate oral surgical procedures (radiotherapy, chemotherapy, corticosteroid use, antiplatelet or anticoagulant drug use, connective tissue diseases, vascular diseases, blood dyscrasia, liver diseases, uncontrolled diabetes, etc.).
- to. Not smoking more than 10 cigarettes per day. f. Having a single rooted tooth of endodontic origin, with a periradicular lesion larger than 5 mm and smaller than 12 mm in diameter detected on periapical radiograph (chronic apical periodontitis), re-canal treatment planned and thought to be unsuccessful with re-canal treatment alone.
Key exclusion criteria (4 listed)
- Having ASA II-III-IV.
- Having a history of allergy to local anesthetics and drugs to be used.
- Presence of a systemic disease or drug use that may adversely affect postoperative wound healing and periodontal health.
- Being pregnant or lactating. to. Not using antiplatelet or anticoagulant drugs and having blood dyscrasias f. Smoking more than 10 cigarettes per day. g. Vertical root fracture, perforation in the furcation region, endo-perio lesion and more than 5 mm periodontal bone loss in the involved tooth.
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 |
|---|---|---|
| Retrograde Filling GroupSurgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and no material will be applied to the bone defect. | Other | 1. group: Retrograde Filling Group / RG Group |
| Retrograde Filling+L-PRF Group2. Group: Surgical curettage of the periapical lesion and root tip resection will be performed, MTA will be applied retrogradely and L-PRF will be applied to the bone defect ( | Other | 2. Group: Retrograde Filling+L-PRF Group / RG+L-PRF Group |
| (Orthograde Filling Group / OG Group).3. Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and no material will be applied to the bone defect | Other | 3. Group: Orthograde Filling Group / OG Group |
| (Orthograde Filling+L-PRF Group4. Group: Surgical curettage of the periapical lesion will be performed, MTA will be applied orthogradely without root tip resection and L-PRF will be applied to the bone defect | Other | 4. Group: Orthograde Filling+L-PRF Group / OG+L-PRF Group |
Primary outcome
Apical lesion healing
Time frame: an average of 1 year
Periapical index score and the dimensions of the periapical radiolucency will be evaluated on the periapical radiographs taken at the control sessions. In addition, pain, swelling, tooth mobility, sensitivity to percussion, sensitivity of palpation and presence of fistula will be evaluated. The PAI is a basic radiographic method of interpretation consisting of a scale from 1 to 5. It was first described by Ørstavik et al in 1986 (14). For each subject, the periapical tissue was assessed radiographically using the PAI as follows: 1. PAI 1: normal periapical structure 2. PAI 2: small changes in the bone structure not pathognomonic of apical periodontitis 3. PAI 3: changes in the bone structure with mineral loss characteristic of apical periodontitis 4. PAI 4: well-defined apical radiolucency characteristic of apical periodontitis 5. PAI 5: severe periodontitis with exacerbating features and bone expansion
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 27 Feb 2026.
- Derived from this study: PubMed 40057596Gulsever S, Ersahan S, Hepsenoglu YE, Tekin A. Apicoectomy versus apical curettage in combination with or without L-PRF application: a randomized clinical trial. Sci Rep. 2025 Mar 8;15(1):8121. doi: 10.1038/s41598-025-92787-y.
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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.
SEYDA ERSAHAN, Assoc.Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrograde Filling Group, Retrograde Filling+L-PRF Group and (Orthograde Filling Group / OG Group). in people with Apical Periodontitis and Periapical Lesion, run by Seyda Ersahan, DDS, PhD at 1 site in Turkey (Türkiye).
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 27 Feb 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 Turkey (Türkiye). 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?
Apical lesion healing (time frame: an average of 1 year). 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 NCT05847647, which also lists 1 linked publication.
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 27 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.