Alveolar Bone LossNCT07779421
THBC/CGF for Alveolar Bone Regeneration: A Real-World Study
A study testing Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor, Temperature-sensitive hydroxybutyl chitosan and Autologous Concentrated Growth Factor in people with Alveolar Bone Loss and Alveolar Ridge Resorption After Extraction, run by Stomatological Hospital Affiliated with Fujian Medical University at 1 site in China.
Trial summary
This study aims to combine real-world research with relevant bone repair materials and techniques to improve alveolar bone resorption in extraction sockets following impacted wisdom tooth removal, while achieving effective bone preservation or promoting bone regeneration. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alveolar Bone Loss, Alveolar Ridge Resorption After Extraction, Tooth, Impacted
- What is being tested?
- Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor, Temperature-sensitive hydroxybutyl chitosan and Autologous Concentrated Growth Factor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2027
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Preoperative CBCT imaging confirming mandibular third molars (M3s) with low to moderate impaction according to the Pell and Gregory classification, and not in the acute inflammatory stage.
- Ipsilateral mandibular second molars (M2s) with retention value and no indication for extraction.
- Patients able to provide written informed consent and willing to comply with the scheduled follow-up visits.
- Age between 18 and 60 years (inclusive).
Who cannot join
- Presence of systemic diseases or other contraindications to tooth extraction surgery.
- Known or suspected current malignancy.
- History of radiation therapy to the head and neck region.
- History of chemotherapy within 5 years prior to surgery.
- Smoking > 15 cigarettes per day.
- Subjects with mental or neurological disorders, or otherwise unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Stomatological Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, 350002
Ye Wu, Ph.D., +86-591-83700838, wuye@fjmu.edu.cn
About this study
Official title: A Real-World Study on Temperature-Sensitive Hydroxybutyl Chitosan-Loaded Concentrated Growth Factor for Alveolar Bone Defect Repair
This study aims to combine real-world research with relevant bone repair materials and techniques to improve alveolar bone resorption in extraction sockets following impacted wisdom tooth removal, while achieving effective bone preservation or promoting bone regeneration. All eligible cases within specified parameters will be included in the clinical study scope. Based on real-world clinical data, we will proactively collect postoperative clinical examination findings and imaging data. Statistical analysis will be performed on clinical outcomes and follow-up data from patients undergoing mandibular impacted M3 extraction. The study aims to clarify the therapeutic efficacy of the thermosensitive hydroxyethylchitosan-loaded concentrated growth factor group in repairing mesial bone defects of M2s following M3 extraction.
Read the detailed description
This study is a prospective observational investigation conducted in a real-world clinical setting. Its objective is to systematically evaluate the clinical efficacy and bone regeneration capacity of a novel composite material, thermosensitive hydroxybutyl chitosan (THBC) loaded with concentrated growth factor (CGF), in the clinical efficacy and bone regenerative capacity for restoring mesial bone defects in second molars following mandibular impacted third molar extraction. The study will enroll patients requiring extraction of mandibular mesial or lower impacted third molars. All participants will select different bone repair options based on clinical circumstances and personal preference, including the THBC+CGF experimental group, autogenous bone graft group, THBC group, CGF group, collagen sponge group, and unfilled control group. Baseline data and intraoperative details will be comprehensively described.
- Being tested
- Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor, Temperature-sensitive hydroxybutyl chitosan, Autologous Concentrated Growth Factor, Natural Healing without Biomaterial Intervention
- Medical subject headings
- Alveolar Bone Loss, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factorCombination product
- THBC Component: Its key component is hydroxybutyl chitosan. The product is supplied as a clear or light yellow, easily flowing liquid at storage temperature (2-8 degrees Celsius) and undergoes a sol-gel transition to form a transparent or semi-transparent gel at body temperature (37 +/- 2 degrees Celsius). The product is composed of hydroxybutyl chitosan, glycerol, and purified water. It is designed to provide a physical barrier, create a moist wound-healing environment, and alleviate pain.
- CGF Component: Concentrated Growth Factor (CGF) is a third-generation autologous platelet concentrate obtained from the patient's own venous blood through a specific centrifugation process. It presents as a dense, three-dimensional fibrin matrix rich in platelets, leukocytes, cytokines, and growth factors (such as PDGF, TGF-beta, VEGF).
- Composite Process: Mixed under sterile conditions, injection flow rate less than or equal to 0.5 mL/s.
Temperature-sensitive hydroxybutyl chitosanDevice
Its key component is hydroxybutyl chitosan. The product is supplied as a clear or light yellow, easily flowing liquid at storage temperature (2-8 degrees Celsius) and undergoes a sol-gel transition to form a transparent or semi-transparent gel at body temperature (37 +/- 2 degrees Celsius). The product is composed of hydroxybutyl chitosan, glycerol, and purified water. It is designed to provide a physical barrier, create a moist wound-healing environment, and alleviate pain.
Autologous Concentrated Growth FactorBiological
Concentrated Growth Factor (CGF) is a third-generation autologous platelet concentrate obtained from the patient's own venous blood through a specific centrifugation process. It presents as a dense, three-dimensional fibrin matrix rich in platelets, leukocytes, cytokines, and growth factors (such as PDGF, TGF-beta, VEGF).
Natural Healing without Biomaterial InterventionOther
After tooth extraction, gently scraping the bone wall induces bleeding, allowing a natural blood clot to form. Within 30 minutes postoperatively, ensure the clot fills more than 90 percent of the socket without applying experimental biomaterials.
| Study group | Role | What they receive |
|---|---|---|
| THBC+CGF Composite | Experimental | Following extraction of the patient's mandibular third molar, immediate placement of a THBC/CGF composite filling was performed. Autologous venous blood was centrifuged, and the resulting CGF clot was compressed into a CGF membrane using specialised instruments. This membrane was mixed with 0.5 mL of THBC solution and injected into the extraction socket. The mixture gelled at 37 degrees Celsius, with a gelation time of less than or equal to 1 minute. Routine infection prevention measures were implemented postoperatively. Receives: Combination Product: Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor |
| THBC | Active comparator | Following extraction of the patient's mandibular third molar, 0.5 mL of THBC was injected into the extraction socket and allowed to gel at 37 degrees Celsius (gelation time less than or equal to 1 minute). Routine infection prevention measures were implemented postoperatively. Receives: Device: Temperature-sensitive hydroxybutyl chitosan |
| CGF | Active comparator | Immediately prior to surgery, venous blood is drawn from the patient and centrifuged without delay. Upon completion of preparation, the resulting CGF clot is compressed into a CGF membrane using specialised instruments. This CGF membrane is implanted directly into the extraction socket within 30 minutes of preparation to cover the bone defect area.Routine infection prevention measures were implemented postoperatively. Receives: Biological: Autologous Concentrated Growth Factor |
| No Filling | Sham comparator | Natural healing after tooth extraction: The extraction socket is filled solely by a blood clot without any implanted biomaterials. Routine infection prevention measures were implemented postoperatively. Receives: Other: Natural Healing without Biomaterial Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day postoperative healing score
Healing of the extraction wound and granulation tissue formation assessed at 7 days postoperatively. Scoring: 3 = complete healing (no gingival redness or swelling); 2 = fistula detected at the distal-middle area of the second molar or mild gingival redness/swelling without infection; 1 = poor healing or obvious redness/swelling without pus; 0 = presence of pus (infection).
Measured: 7 days after surgery
Alveolar Bone Width（ Millimeters）
Width of the alveolar bone measured as the distance from the crest of the buccal alveolar ridge to the crest of the lingual alveolar ridge, using the CT scanner's built-in measurement software.
Measured: Pre-operative, 3 months post-operative，6 months post-operative
Alveolar Bone Height（Millimeters）
Height of the alveolar bone measured as the vertical distance from the highest point of the alveolar bone to the upper wall of the mandibular canal, using the CT scanner's built-in measurement software.
Measured: Pre-operative; 3 months post-operative，6 months post-operative
Second Molar Mobility (Modified Miller Grade)
Mobility of the second molar assessed using the modified Miller grading system with two standard metal dental instrument handles (e.g., mouth mirror handle and probe handle). Grade 0 = no mobility; Grade I = labial/lingual mobility <1 mm; Grade II = labial/lingual mobility 1-2 mm; Grade III = labial/lingual mobility >2 mm with vertical mobility.
Measured: Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery
Mouth Opening Width（Millimeters）
Maximum interincisal distance (between the incisal margins of the upper and lower incisors) measured using standard calipers.
Measured: Preoperative，1 day after surgery, 3 days after surgery, 7 days after surgery
Postoperative pain (VAS score)
Patient-reported pain intensity on a 10-point visual analogue scale (VAS) with verbal descriptors: 0 = no pain; 1-3 = mild pain, not interfering with sleep; 4-6 = moderate pain, mildly interfering with sleep; 7-9 = severe pain, preventing sleep and requiring medication; 10 = worst possible pain.
Measured: 1 day after surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery
Swelling degree（millimeter）
Facial swelling measured as the distance from the tragus to the corner of the mouth on the extraction side, using a soft tape measure.
Measured: Preoperative, 1 day postoperative, 3 days postoperative, 7 days postoperative
Second Molar Probing Depth (Mean of Three Sites)
Probing depth (PD) recorded at three sites of the second molar periodontium (buccal distal-medial, mid-distal, and lingual distal-medial) using a periodontal probe. The final reported value will be the mean of the three site measurements. PD is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Measured: Preoperative, 14 days postoperative, 3 months postoperative
Second Molar Probing Tenderness（Ordinal category ）
Vertical percussion of the occlusal surface of the second molar (M2) using the handle of a metal dental mirror, compared with the contralateral healthy tooth. Response graded as: (-) = no discomfort, identical to control; (±) = abnormal sensation/soreness, not clearly pain; (+) = clear pain, tolerable; (++) = sharp pain provoking avoidance; (+++) = severe pain, refusal of further examination.
Measured: Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery
Postoperative Bleeding
Presence of active bleeding from the extraction wound and presence of blood clot formation assessed at 30 minutes postoperatively. Recorded as present/absent.
Measured: 30 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Aug 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ye Wu, Ph.D., Principal investigator, Stomatological Hospital Affiliated with Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779421
- Sponsor's protocol ID
- 2024Clin004
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on Temperature-Sensitive Hydroxybutyl Chitosan-Loaded Concentrated Growth Factor for Alveolar Bone Defect Repair
- ClinicalTrials.gov ID
- NCT07779421
- Acronym / sponsor ID
- 2024Clin004
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Aug 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 study aims to combine real-world research with relevant bone repair materials and techniques to improve alveolar bone resorption in extraction sockets following impacted wisdom tooth removal, while achieving effective bone preservation or promoting bone regeneration. All eligible cases within specified parameters will be included in the clinical study scope. Based on real-world clinical data, we will proactively collect postoperative clinical examination findings and imaging data. Statistical analysis will be performed on clinical outcomes and follow-up data from patients undergoing mandibular impacted M3 extraction. The study aims to clarify the therapeutic efficacy of the thermosensitive hydroxyethylchitosan-loaded concentrated growth factor group in repairing mesial bone defects of M2s following M3 extraction.
Detailed description
This study is a prospective observational investigation conducted in a real-world clinical setting. Its objective is to systematically evaluate the clinical efficacy and bone regeneration capacity of a novel composite material, thermosensitive hydroxybutyl chitosan (THBC) loaded with concentrated growth factor (CGF), in the clinical efficacy and bone regenerative capacity for restoring mesial bone defects in second molars following mandibular impacted third molar extraction. The study will enroll patients requiring extraction of mandibular mesial or lower impacted third molars. All participants will select different bone repair options based on clinical circumstances and personal preference, including the THBC+CGF experimental group, autogenous bone graft group, THBC group, CGF group, collagen sponge group, and unfilled control group. Baseline data and intraoperative details will be comprehensively described.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| THBC+CGF Composite | Experimental | Combination Product: Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factorFollowing extraction of the patient's mandibular third molar, immediate placement of a THBC/CGF composite filling was performed. Autologous venous blood was centrifuged, and the resulting CGF clot was compressed into a CGF membrane using specialised instruments. This membrane was mixed with 0.5 mL of THBC solution and injected into the extraction socket. The mixture gelled at 37 degrees Celsius, with a gelation time of less than or equal to 1 minute. Routine infection prevention measures were implemented postoperatively. |
| THBC | Active comparator | Device: Temperature-sensitive hydroxybutyl chitosanFollowing extraction of the patient's mandibular third molar, 0.5 mL of THBC was injected into the extraction socket and allowed to gel at 37 degrees Celsius (gelation time less than or equal to 1 minute). Routine infection prevention measures were implemented postoperatively. |
| CGF | Active comparator | Biological: Autologous Concentrated Growth FactorImmediately prior to surgery, venous blood is drawn from the patient and centrifuged without delay. Upon completion of preparation, the resulting CGF clot is compressed into a CGF membrane using specialised instruments. This CGF membrane is implanted directly into the extraction socket within 30 minutes of preparation to cover the bone defect area.Routine infection prevention measures were implemented postoperatively. |
| No Filling | Sham comparator | Other: Natural Healing without Biomaterial InterventionNatural healing after tooth extraction: The extraction socket is filled solely by a blood clot without any implanted biomaterials. Routine infection prevention measures were implemented postoperatively. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Preoperative CBCT imaging confirming mandibular third molars (M3s) with low to moderate impaction according to the Pell and Gregory classification, and not in the acute inflammatory stage.
- Ipsilateral mandibular second molars (M2s) with retention value and no indication for extraction.
- Patients able to provide written informed consent and willing to comply with the scheduled follow-up visits.
- Age between 18 and 60 years (inclusive).
Key exclusion criteria (6 listed)
- Presence of systemic diseases or other contraindications to tooth extraction surgery.
- Known or suspected current malignancy.
- History of radiation therapy to the head and neck region.
- History of chemotherapy within 5 years prior to surgery.
- Smoking > 15 cigarettes per day.
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 |
|---|---|---|
| Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor* THBC Component: Its key component is hydroxybutyl chitosan. The product is supplied as a clear or light yellow, easily flowing liquid at storage temperature (2-8 degrees Celsius) and undergoes a sol-gel transition to form a transparent or semi-transparent gel at body temperature (37 +/- 2 degrees Celsius). The product is composed of hydroxybutyl chitosan, glycerol, and purified water. It is designed to provide a physical barrier, create a moist wound-healing environment, and alleviate pain. * CGF Component: Concentrated Growth Factor (CGF) is a third-generation autologous platelet concentrate obtained from the patient's own venous blood through a specific centrifugation process. It presents as a dense, three-dimensional fibrin matrix rich in platelets, leukocytes, cytokines, and growth factors (such as PDGF, TGF-beta, VEGF). * Composite Process: Mixed under sterile conditions, injection flow rate less than or equal to 0.5 mL/s. | Combination product | THBC+CGF Composite |
| Temperature-sensitive hydroxybutyl chitosanIts key component is hydroxybutyl chitosan. The product is supplied as a clear or light yellow, easily flowing liquid at storage temperature (2-8 degrees Celsius) and undergoes a sol-gel transition to form a transparent or semi-transparent gel at body temperature (37 +/- 2 degrees Celsius). The product is composed of hydroxybutyl chitosan, glycerol, and purified water. It is designed to provide a physical barrier, create a moist wound-healing environment, and alleviate pain. | Device | THBC |
| Autologous Concentrated Growth FactorConcentrated Growth Factor (CGF) is a third-generation autologous platelet concentrate obtained from the patient's own venous blood through a specific centrifugation process. It presents as a dense, three-dimensional fibrin matrix rich in platelets, leukocytes, cytokines, and growth factors (such as PDGF, TGF-beta, VEGF). | Biological | CGF |
| Natural Healing without Biomaterial InterventionAfter tooth extraction, gently scraping the bone wall induces bleeding, allowing a natural blood clot to form. Within 30 minutes postoperatively, ensure the clot fills more than 90 percent of the socket without applying experimental biomaterials. | Other | No Filling |
Primary outcome
7-day postoperative healing score
Time frame: 7 days after surgery
Healing of the extraction wound and granulation tissue formation assessed at 7 days postoperatively. Scoring: 3 = complete healing (no gingival redness or swelling); 2 = fistula detected at the distal-middle area of the second molar or mild gingival redness/swelling without infection; 1 = poor healing or obvious redness/swelling without pus; 0 = presence of pus (infection).
Alveolar Bone Width（ Millimeters）
Time frame: Pre-operative, 3 months post-operative，6 months post-operative
Width of the alveolar bone measured as the distance from the crest of the buccal alveolar ridge to the crest of the lingual alveolar ridge, using the CT scanner's built-in measurement software.
Alveolar Bone Height（Millimeters）
Time frame: Pre-operative; 3 months post-operative，6 months post-operative
Height of the alveolar bone measured as the vertical distance from the highest point of the alveolar bone to the upper wall of the mandibular canal, using the CT scanner's built-in measurement software.
Second Molar Mobility (Modified Miller Grade)
Time frame: Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery
Mobility of the second molar assessed using the modified Miller grading system with two standard metal dental instrument handles (e.g., mouth mirror handle and probe handle). Grade 0 = no mobility; Grade I = labial/lingual mobility <1 mm; Grade II = labial/lingual mobility 1-2 mm; Grade III = labial/lingual mobility >2 mm with vertical mobility.
Mouth Opening Width（Millimeters）
Time frame: Preoperative，1 day after surgery, 3 days after surgery, 7 days after surgery
Maximum interincisal distance (between the incisal margins of the upper and lower incisors) measured using standard calipers.
Postoperative pain (VAS score)
Time frame: 1 day after surgery, 3 days after surgery, 7 days after surgery, 14 days after surgery
Patient-reported pain intensity on a 10-point visual analogue scale (VAS) with verbal descriptors: 0 = no pain; 1-3 = mild pain, not interfering with sleep; 4-6 = moderate pain, mildly interfering with sleep; 7-9 = severe pain, preventing sleep and requiring medication; 10 = worst possible pain.
Swelling degree（millimeter）
Time frame: Preoperative, 1 day postoperative, 3 days postoperative, 7 days postoperative
Facial swelling measured as the distance from the tragus to the corner of the mouth on the extraction side, using a soft tape measure.
Second Molar Probing Depth (Mean of Three Sites)
Time frame: Preoperative, 14 days postoperative, 3 months postoperative
Probing depth (PD) recorded at three sites of the second molar periodontium (buccal distal-medial, mid-distal, and lingual distal-medial) using a periodontal probe. The final reported value will be the mean of the three site measurements. PD is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Second Molar Probing Tenderness（Ordinal category ）
Time frame: Preoperative，7 days after surgery, 14 days after surgery, 3 months after surgery
Vertical percussion of the occlusal surface of the second molar (M2) using the handle of a metal dental mirror, compared with the contralateral healthy tooth. Response graded as: (-) = no discomfort, identical to control; (±) = abnormal sensation/soreness, not clearly pain; (+) = clear pain, tolerable; (++) = sharp pain provoking avoidance; (+++) = severe pain, refusal of further examination.
Postoperative Bleeding
Time frame: 30 minutes after surgery
Presence of active bleeding from the extraction wound and presence of blood clot formation assessed at 30 minutes postoperatively. Recorded as present/absent.
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 21 Aug 2026.
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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.
Stomatological Hospital Affiliated with Fujian Medical University
Fuzhou, China
Ye Wu, Ph.D. principal investigator
Stomatological Hospital Affiliated with Fujian Medical 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 Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor, Temperature-sensitive hydroxybutyl chitosan and Autologous Concentrated Growth Factor in people with Alveolar Bone Loss and Alveolar Ridge Resorption After Extraction, run by Stomatological Hospital Affiliated with Fujian Medical University at 1 site 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 4 inclusion and 6 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 21 Aug 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 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day postoperative healing score (time frame: 7 days after surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.