Periapical PeriodontitisNCT07501585
Hyaluronic Acid in Endodontic Microsurgery
A study testing Hyaluronic Acid and Endodontic microsurgery in people with Periapical Periodontitis, run by University of Bern at 1 site in Russia.
Trial summary
This randomized clinical trial (RCT) will evaluate the effectiveness of cross-linked hyaluronic acid as an adjunct to endodontic microsurgery in adult patients with apical periodontitis affecting maxillary or mandibular first molars. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Hyaluronic Acid and Endodontic microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteRussia
- Study dates
- 20 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- ≥18 years of age
- Apical peridontitis at maxillar or mandibular first molars ≥ 12 months after non-surgical endodontical treatment
- Full mouth plaque score (FMPS) and bleeding score (BoP) < or 20%
- Periapical lesion < or 10 mm
- Four-wall bone defect morphology
Who cannot join
- Smokers of more than 10 cigarettes a day
- Allergy to hyaluronic acid
- Pregnancy or lactation
- Uncontrolled Diabetes
- Untreated periodontal conditions
- Any conditions associated with poor compliance or failure to maintain good oral hygiene
- Acute infections lesions in areas intended for surgery
- Chemotherapy and radiotherapy treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Praktika 1
Moscow, 127006
Anton Sculean, Prof, +41316840620, anton.sculean@unibe.ch
Alexandra Stähli, PD, +41316840620, alexandra.staehli@unibe.ch
About this study
Official title: Effectiveness of Using Cross-linked Hyaluronic Acid in Endodontic Microsurgery. A RCT
This randomized clinical trial (RCT) will evaluate the effectiveness of cross-linked hyaluronic acid as an adjunct to endodontic microsurgery in adult patients with apical periodontitis affecting maxillary or mandibular first molars. Participants previously treated with non-surgical endodontic therapy will be allocated to either endodontic microsurgery with cross-linked hyaluronic acid application (test group) or the same surgical procedure without adjunctive material (control group), with 12 months of follow-up.
The study hypothesis is that cross-linked hyaluronic acid improves soft- and hard-tissue healing, reduces postoperative inflammation and pain, and supports more stable surgical outcomes. Primary outcomes include early soft tissue healing (Early Wound Healing Score, day 4) and postoperative pain (visual analogue scale). Secondary outcomes include periapical healing assessed by blinded evaluators on periapical radiographs (Molven criteria) at 3, 6, and 12 months, and on CBCT scans (PENN 3D criteria) at 6 and 12 months, as well as cortical plate healing (RAC/B index). This study aims to provide clinical evidence on the potential regenerative and anti-inflammatory benefits of cross-linked hyaluronic acid in endodontic microsurgery.
Read the detailed description
Background and Rationale:
Endodontic microsurgery is an established treatment for persistent apical periodontitis after non-surgical root canal treatment. Successful healing depends on appropriate surgical technique, infection control, and favorable soft and hard tissue regeneration. Cross-linked hyaluronic acid is a non-animal-origin biomaterial with hydrating, tissue-supportive, and bacteriostatic properties, and may support wound healing and tissue regeneration in oral surgery. In addition, it is stable at room temperature and radiolucent, which facilitates postoperative radiographic and CBCT evaluation.
The present study investigates whether adjunctive use of cross-linked hyaluronic acid during endodontic microsurgery improves clinical healing outcomes compared with standard endodontic microsurgery alone.
Scientific Question:
Does cross-linked hyaluronic acid improve hard and soft tissue regeneration in endodontic microsurgery?
Hypothesis:
The adjunctive use of cross-linked hyaluronic acid in endodontic microsurgery improves soft-tissue and bone-healing, reduces inflammation and postoperative pain, and enhances the long-term stability of surgical outcomes.
Study type: Interventional (Clinical Trial) Allocation: Randomized Intervention model: Parallel assignment Masking: Double-blinded (participant and outcome examiner/radiologist) Primary purpose: Treatment Setting: Single center Follow-up duration: 12 months
Study Population:
Adult patients (>18 years) with apical periodontitis in maxillary or mandibular first molars, previously treated with non-surgical endodontic therapy at least 12 months prior to enrollment, and meeting predefined periodontal and radiographic eligibility criteria.
Interventions:
Test Group (n=30 teeth) Endodontic microsurgery (open flap debridement) with adjunctive application of cross-linked hyaluronic acid (Hyadent BG, Regedent) into the osteotomy defect and under the flap before closure.
Control Group (n=30 teeth) Endodontic microsurgery (open flap debridement) with no adjunctive grafting/regenerative material.
Surgical Procedure (both groups):
All procedures will be performed under an operating microscope (Carl Zeiss Extaro 300) using a standardized microsurgical protocol under local anesthesia (articaine with epinephrine 1:100,000, 3.4 mL). The protocol includes:
Single flap approach (Trombelli 2009) combined with entire papilla preservation technique (Aslan et al.).
- Flap elevation
- Osteotomy with Lindemann bur under irrigation
- 3 mm root-end resection at approximately 90 degrees
- Root-end staining with 1% methylene blue
- Ultrasonic retrograde preparation
- Granulation tissue removal
- Hemostasis with epinephrine cotton pellets
- Root-end filling with mineral trioxide aggregate (MTA, Trioxident)
- Irrigation with 0.9% sodium chloride
- Periosteoplasty
- Tension-free flap repositioning and suturing with 7-0 monofilament sutures (Prolene)
- In the test group only, cross-linked hyaluronic acid will be applied via cannula to fill the osteotomy defect and placed beneath the flap prior to suturing.
Outcome Measures:
Primary Outcome: Early soft tissue healing Assessed on postoperative day 4 using the Early Wound Healing Score (EHS).
Secondary Outcomes
- Periapical healing on periapical radiographs (PA) Assessed by blinded evaluators using Molven criteria at 3, 6, and 12 months
- Periapical healing on CBCT Assessed by blinded evaluators using PENN 3D criteria at 6 and 12 months
- Cortical plate healing Assessed using the RAC/B index
- Postoperative pain Assessed using a Visual Analogue Scale (VAS).
Statistical Considerations
Sample size calculation was based on detecting a 2-point difference in the Early Wound Healing Score (range 0-10) between groups, assuming:
Alpha = 0.05 Power = 80% Standard deviation = 3 The calculated sample size was approximately 18 patients per group. To account for potential dropouts and ensure robustness, the final planned sample size is 23 patients per group. The protocol currently plans enrollment of 30 teeth per group, providing additional allowance for attrition and variability.
- Conditions
- Periapical Periodontitis
- Being tested
- Hyaluronic Acid, Endodontic microsurgery
- Keywords
- Endodontic microsurgery
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidProcedure or surgery
The endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be coloured with methylen-blue 1%, retrograde canal preparation using ultrasonic scaler, and ultrasonic tips, granulated tissues excavation, haemostasis will be achieved by using cotton balls with epinephrine, root-end filling with mineral trioxide aggregate. Irrigation with 0.9% sodium chloride, application of cross-linked hyaluronic acid through the cannula into the osteotomy, until the bone defect is completely filled and under the flap, flap reposition tension-free, suturing using monofilament sutures 7-0 (Prolene).
Endodontic microsurgeryProcedure or surgery
The endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be coloured with methylen-blue 1%, retrograde canal preparation using ultrasonic scaler, and ultrasonic tips, granulated tissues excavation, haemostasis will be achieved by using cotton balls with epinephrine, root-end filling with mineral trioxide aggregate. Irrigation with 0.9% sodium chloride, flap reposition tension-free, suturing using monofilament sutures 7-0 (Prolene).
| Study group | Role | What they receive |
|---|---|---|
| Test: endodontic microsurgery with hyaluronic acid | Experimental | The endodontic microsurgery will be performed, then cross-linked hyaluronic acid will be added in the surgical area. Receives: Procedure: Hyaluronic Acid; Procedure: Endodontic microsurgery |
| Control: mere endodontic microsurgery | Active comparator | Endodontic microsurgery will be performed only. Receives: Procedure: Endodontic microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The healing of soft tissues will be evaluated by the Early wound healing score
The early wound healing index assesses periodontal soft tissue healing, usually around 1 week post-surgery, by evaluating flap closure, fibrin presence, and necrosis in 5 grades. It ranges from score 1 (complete healing) to score 5 (necrosis and pus)
Measured: 4 days after surgery
Secondary outcomes (4)
The postoperative pain will be evaluated by visual analogue scale VAS
The visual analogue scale is a mm scale from 0 (no pain) to 100 mm (maximal possible pain)
Measured: within the two first weeks after surgery
Periapical healing assessed on periapical radiographs according to the Molven's criteria
The Molven's criteria is a 2D radiographic classification system used to evaluate the healing outcome of apical endodontic surgery, four main categories exist: Complete Healing: Bone tissue is completely restored, and a normal periodontal ligament (PDL) space is visible.
Incomplete Healing (Scar Tissue): The initial radiolucent area has reduced in size, but a small residual rarefaction remains, often characterized as a "scar".
Uncertain Healing: A reduction in the size of the lesion has occurred, but it does not fit the criteria for complete or incomplete healing.
Unsatisfactory Healing (Failures): The radiolucent lesion is unchanged, has increased in size, or appears newly developed, indicating failure.
Measured: 3, 6, and 12 months post-surgery
Pericapial healing on cone beam computed tomography (CBCT) scans according to PENN's criteria
Healing of endodontic microsurgery assessed using CBCT imaging, categories: Complete Healing (Success): Full bone repair, with the periodontal space having a normal width.
Limited Healing (Success): Bone regeneration, but the periodontal space over the resected root surface is slightly widened (but less than twice the width of non-involved root).
Uncertain Healing (Failure): A small defect or continued radiolucency persists in the lamina dura around the root-end filling.
Unsatisfactory Healing (Failure): No change or an increase in the size of the radiolucent area, with poor bone repair.
Measured: 6 and 12 months post-surgery
Cortical plate healing
Cortical plate healing will be scored according to the RAC/B index:
Score 0: Cortical plate not re-established. Score 1: Cortical plate is partially re-established. Score 2: Cortical plate is re-established
Measured: 6 and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical 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
- Model description
- This is a double-armed, single-center, double-blinded randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anton Sculean, Prof., Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501585
- Sponsor's protocol ID
- HA in endo surgery
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Cross-linked Hyaluronic Acid in Endodontic Microsurgery. A RCT
- ClinicalTrials.gov ID
- NCT07501585
- Acronym / sponsor ID
- HA in endo surgery
- Conditions
- Periapical Periodontitis
- Keywords
- Endodontic microsurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Mar 2026 (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 randomized clinical trial (RCT) will evaluate the effectiveness of cross-linked hyaluronic acid as an adjunct to endodontic microsurgery in adult patients with apical periodontitis affecting maxillary or mandibular first molars. Participants previously treated with non-surgical endodontic therapy will be allocated to either endodontic microsurgery with cross-linked hyaluronic acid application (test group) or the same surgical procedure without adjunctive material (control group), with 12 months of follow-up.
The study hypothesis is that cross-linked hyaluronic acid improves soft- and hard-tissue healing, reduces postoperative inflammation and pain, and supports more stable surgical outcomes. Primary outcomes include early soft tissue healing (Early Wound Healing Score, day 4) and postoperative pain (visual analogue scale). Secondary outcomes include periapical healing assessed by blinded evaluators on periapical radiographs (Molven criteria) at 3, 6, and 12 months, and on CBCT scans (PENN 3D criteria) at 6 and 12 months, as well as cortical plate healing (RAC/B index). This study aims to provide clinical evidence on the potential regenerative and anti-inflammatory benefits of cross-linked hyaluronic acid in endodontic microsurgery.
Detailed description
Background and Rationale:
Endodontic microsurgery is an established treatment for persistent apical periodontitis after non-surgical root canal treatment. Successful healing depends on appropriate surgical technique, infection control, and favorable soft and hard tissue regeneration. Cross-linked hyaluronic acid is a non-animal-origin biomaterial with hydrating, tissue-supportive, and bacteriostatic properties, and may support wound healing and tissue regeneration in oral surgery. In addition, it is stable at room temperature and radiolucent, which facilitates postoperative radiographic and CBCT evaluation.
The present study investigates whether adjunctive use of cross-linked hyaluronic acid during endodontic microsurgery improves clinical healing outcomes compared with standard endodontic microsurgery alone.
Scientific Question:
Does cross-linked hyaluronic acid improve hard and soft tissue regeneration in endodontic microsurgery?
Hypothesis:
The adjunctive use of cross-linked hyaluronic acid in endodontic microsurgery improves soft-tissue and bone-healing, reduces inflammation and postoperative pain, and enhances the long-term stability of surgical outcomes.
Study type: Interventional (Clinical Trial) Allocation: Randomized Intervention model: Parallel assignment Masking: Double-blinded (participant and outcome examiner/radiologist) Primary purpose: Treatment Setting: Single center Follow-up duration: 12 months
Study Population:
Adult patients (>18 years) with apical periodontitis in maxillary or mandibular first molars, previously treated with non-surgical endodontic therapy at least 12 months prior to enrollment, and meeting predefined periodontal and radiographic eligibility criteria.
Interventions:
Test Group (n=30 teeth) Endodontic microsurgery (open flap debridement) with adjunctive application of cross-linked hyaluronic acid (Hyadent BG, Regedent) into the osteotomy defect and under the flap before closure.
Control Group (n=30 teeth) Endodontic microsurgery (open flap debridement) with no adjunctive grafting/regenerative material.
Surgical Procedure (both groups):
All procedures will be performed under an operating microscope (Carl Zeiss Extaro 300) using a standardized microsurgical protocol under local anesthesia (articaine with epinephrine 1:100,000, 3.4 mL). The protocol includes:
Single flap approach (Trombelli 2009) combined with entire papilla preservation technique (Aslan et al.).
- Flap elevation
- Osteotomy with Lindemann bur under irrigation
- 3 mm root-end resection at approximately 90 degrees
- Root-end staining with 1% methylene blue
- Ultrasonic retrograde preparation
- Granulation tissue removal
- Hemostasis with epinephrine cotton pellets
- Root-end filling with mineral trioxide aggregate (MTA, Trioxident)
- Irrigation with 0.9% sodium chloride
- Periosteoplasty
- Tension-free flap repositioning and suturing with 7-0 monofilament sutures (Prolene)
- In the test group only, cross-linked hyaluronic acid will be applied via cannula to fill the osteotomy defect and placed beneath the flap prior to suturing.
Outcome Measures:
Primary Outcome: Early soft tissue healing Assessed on postoperative day 4 using the Early Wound Healing Score (EHS).
Secondary Outcomes
- Periapical healing on periapical radiographs (PA) Assessed by blinded evaluators using Molven criteria at 3, 6, and 12 months
- Periapical healing on CBCT Assessed by blinded evaluators using PENN 3D criteria at 6 and 12 months
- Cortical plate healing Assessed using the RAC/B index
- Postoperative pain Assessed using a Visual Analogue Scale (VAS).
Statistical Considerations
Sample size calculation was based on detecting a 2-point difference in the Early Wound Healing Score (range 0-10) between groups, assuming:
Alpha = 0.05 Power = 80% Standard deviation = 3 The calculated sample size was approximately 18 patients per group. To account for potential dropouts and ensure robustness, the final planned sample size is 23 patients per group. The protocol currently plans enrollment of 30 teeth per group, providing additional allowance for attrition and variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-armed, single-center, double-blinded randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test: endodontic microsurgery with hyaluronic acid | Experimental | Procedure: Hyaluronic Acid, Procedure: Endodontic microsurgeryThe endodontic microsurgery will be performed, then cross-linked hyaluronic acid will be added in the surgical area. |
| Control: mere endodontic microsurgery | Active comparator | Procedure: Endodontic microsurgeryEndodontic microsurgery will be performed only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- ≥18 years of age
- Apical peridontitis at maxillar or mandibular first molars ≥ 12 months after non-surgical endodontical treatment
- Full mouth plaque score (FMPS) and bleeding score (BoP) < or 20%
- Periapical lesion < or 10 mm
Key exclusion criteria (8 listed)
- Smokers of more than 10 cigarettes a day
- Allergy to hyaluronic acid
- Pregnancy or lactation
- Uncontrolled Diabetes
- Untreated periodontal conditions
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 |
|---|---|---|
| Hyaluronic AcidThe endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be coloured with methylen-blue 1%, retrograde canal preparation using ultrasonic scaler, and ultrasonic tips, granulated tissues excavation, haemostasis will be achieved by using cotton balls with epinephrine, root-end filling with mineral trioxide aggregate. Irrigation with 0.9% sodium chloride, application of cross-linked hyaluronic acid through the cannula into the osteotomy, until the bone defect is completely filled and under the flap, flap reposition tension-free, suturing using monofilament sutures 7-0 (Prolene). | Procedure or surgery | Test: endodontic microsurgery with hyaluronic acid |
| Endodontic microsurgeryThe endodontic surgery will be performed under the control of an operating microscope (Carl Zeiss Extaro 300). The operation will be performed under anesthesia, articaine + epinephrine. OFD (single flap approach Trombelli 2009 combined with entire papilla preservation technique Aslan et al., flap elevation, osteotomy, 3 mm root resection, the root cut will be made at an angle close to 90 degrees, the root cut will be coloured with methylen-blue 1%, retrograde canal preparation using ultrasonic scaler, and ultrasonic tips, granulated tissues excavation, haemostasis will be achieved by using cotton balls with epinephrine, root-end filling with mineral trioxide aggregate. Irrigation with 0.9% sodium chloride, flap reposition tension-free, suturing using monofilament sutures 7-0 (Prolene). | Procedure or surgery | Control: mere endodontic microsurgery, Test: endodontic microsurgery with hyaluronic acid |
Primary outcome
The healing of soft tissues will be evaluated by the Early wound healing score
Time frame: 4 days after surgery
The early wound healing index assesses periodontal soft tissue healing, usually around 1 week post-surgery, by evaluating flap closure, fibrin presence, and necrosis in 5 grades. It ranges from score 1 (complete healing) to score 5 (necrosis and pus)
4 secondary outcomes
The postoperative pain will be evaluated by visual analogue scale VAS
Time frame: within the two first weeks after surgery
Periapical healing assessed on periapical radiographs according to the Molven's criteria
Time frame: 3, 6, and 12 months post-surgery
Pericapial healing on cone beam computed tomography (CBCT) scans according to PENN's criteria
Time frame: 6 and 12 months post-surgery
Cortical plate healing
Time frame: 6 and 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anton Sculean, Prof. study chair
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid and Endodontic microsurgery in people with Periapical Periodontitis, run by University of Bern at 1 site in Russia.
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 8 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: looking for participants now, as of the sponsor's last update on 30 Mar 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 Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton Sculean, Prof. (+41316840620, anton.sculean@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The healing of soft tissues will be evaluated by the Early wound healing score (time frame: 4 days after surgery). 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 30 Mar 2026.