Alveolar Bone Loss* / Therapy
Conditions
Keywords
Alveolar bone, Collagen, Silk fibroin, Membrane material
Brief summary
Based on the mechanism of intramembranous ossification of the alveolar bone, it is necessary to design a biomimetic membrane material based on the principle of GBR (Guided Bone Regeneration) to simulate the biological microenvironment of alveolar bone regeneration, promote the direct differentiation of stem cells into osteoblasts and rapid mineralization, thereby achieving the goal of alveolar bone regeneration. This section, based on bionic principles, proposes to enhance the mechanical properties of the collagen membrane with silk fibroin to achieve synergistic regeneration of periodontal bone/soft tissue. This project employs silk fibroin-reinforced collagen membrane technology to overcome the dual bottlenecks of insufficient strength and excessively rapid degradation of existing materials; establishes a "structure-guided, mechanically supported, factor-controlled release" trinity regeneration strategy to achieve precise repair of periodontal composite tissues. This study will provide new materials and methods for periodontal regeneration and offer a theoretical reference for the combined regeneration of other hard/soft tissues.
Interventions
OTHERSilk Fibroin-Reinforced Collagen-Based Composite Membrane
Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical Diagnosis: Meets the 2018 International Classification of Periodontal Diseases, diagnosed with Stage III or IV periodontitis. * Bone Defect Characteristics: At least one affected tooth presents with a deep periodontal pocket (PPD ≥5 mm), and CBCT imaging confirms the presence of significant vertical bone resorption or angular bone defects (these defect types are most suitable for in-situ hydrogel filling and guided regeneration). * Age and General Condition: Aged between 18 and 70 years, any gender, generally in good systemic health. * Compliance and Consent: The subject is able to understand the study procedures, voluntarily sign the informed consent form, and commit to returning for follow-up visits as required (1, 3, 6, 12 months).
Exclusion criteria
* Systemic Interference with Bone Metabolism: Presence of poorly controlled diabetes (HbA1c \> 7%), osteoporosis, or long-term use of medications affecting bone metabolism such as bisphosphonates or glucocorticoids within the past six months. * Local Anatomical Limitations: The affected tooth has a vertical root fracture, severe periapical pathology, or a residual root that is deemed non-restorable and without preservation value. * Factors Interfering with Healing: Heavy smokers (average \> 10 cigarettes per day), as impaired microcirculation can significantly compromise the biological effects of the hydrogel. * Special Physiological Periods: Pregnant or breastfeeding women. Drug Allergy: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertical Bone Defect Fill Height (VBH) | Up to 12 month | Three-dimensional reconstruction using CBCT (Cone Beam Computed Tomography) to measure the change in distance from the base of the bone defect to the alveolar crest between pre-operative and post-operative scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alveolar Bone Density | Up to 12 month | Gray value calculation of the region of interest (ROI) using CBCT software. |
Contacts
CONTACTWenjie Ren
PRINCIPAL_INVESTIGATORWenjie Ren
The First Affiliated Hospital of Xinxiang Medical College
Outcome results
None listed