RECRUITING Not applicable ClinicalTrials.gov

THBC/CGF for Alveolar Bone Regeneration: A Real-World Study

Sponsor: Stomatological Hospital Affiliated with Fujian Medical University • ClinicalTrials.gov ID: NCT07779421

Registry updated: 2026-08-21

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Temperature-sensitive hydroxybutyl chitosan-loaded concentrated growth factor (Combination 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 chitosan (Device)
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 (Biological)
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 (Other)
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.

Eligibility criteria

* Inclusion Criteria: * 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). * Exclusion Criteria: * 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.

Conditions

Alveolar Bone Loss Alveolar Ridge Resorption After Extraction Tooth, Impacted

Locations

Stomatological Hospital Affiliated with Fujian Medical University — Fuzhou, Fujian, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment