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THBC/CGF for Alveolar Bone Regeneration: A Real-World Study
Sponsor: Stomatological Hospital Affiliated with Fujian Medical University
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. 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.
Official title: A Real-World Study on Temperature-Sensitive Hydroxybutyl Chitosan-Loaded Concentrated Growth Factor for Alveolar Bone Defect Repair
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2024-08-01
Completion Date
2027-07-31
Last Updated
2026-08-21
Healthy Volunteers
No
Interventions
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.
Temperature-sensitive hydroxybutyl chitosan
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 Factor
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 Intervention
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.
Locations (1)
Stomatological Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, China