Alveolar Bone Defect Repair
Conditions
Interventions
Experimental Group:When used in combination with bone graft material for alveolar bone defect repair, the oral repair membrane plays a physical barrier role
Control Group:When the absorbable biomembrane (Bilayer Collagen Membrane) is used in combination with bone graft material for alveolar bone defect repair, it plays a physical barrier role
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 65 years old (inclusive), regardless of gender(2) Patients who have undergone single-tooth extraction in the anterior aesthetic zone (canines, lateral incisors, central incisors), premolar region, or molar region(3) Patients with at least one intact adjacent tooth at the extraction site(4) Patients who voluntarily participate in this clinical trial and sign the informed consent form
Exclusion criteria
Exclusion criteria: (1) Patients with conditions in the oral cavity that cause artifacts in imaging examinations of the surgical area(2) Patients with alveolar socket bone wall defects on multiple sides (> 2 sides)(3) Patients with progressive periodontal disease(4) Patients with poorly controlled diabetes (fasting blood glucose >= 7.0 mmol/L even with medication control)(5) Patients with NYHA classification of Grade II or higher(6) Patients with abnormal liver or kidney function (ALT or AST exceeding 2 times the normal value, or creatinine exceeding the normal range, and judged by the researcher to be clinically significant)(7) Patients with abnormal coagulation function(8) Patients with a history of local radiotherapy to the head or neck within 5 years before surgery(9) Patients who have previously used bisphosphonates, or have systematically used drugs that may affect or promote bone metabolism within 3 months before surgery (including calcitonin, parathyroid hormone, high-dose corticosteroids [taken continuously for more than 3 months], immunosuppressants, and other drugs that the researcher deems may affect bone metabolism)(10) Patients with drug addiction, alcoholism, substance abuse, or those who report smoking/tobacco equivalents/chewing tobacco more than 10 times per day(11) Patients with known allergies to L-lactide-caprolactone copolymer, polycaprolactone materials, or collagen(12) Patients with uncontrolled acute or chronic infection in the surgical area(13) Patients with uncontrolled systemic diseases who cannot undergo tooth extraction surgery(14) Pregnant or lactating women(15) Patients currently participating in other clinical trials of drugs or medical devices(16) Patients who are deemed unsuitable for participating in this clinical trial by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Alveolar Bone Height at 24 Weeks Postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Intraoperative Instrument Performance;Change in Alveolar Bone Horizontal Width at 24 Weeks Postoperatively;Assessment of Wound Healing at 12 Weeks Postoperatively;Evaluation of Satisfaction with the Surgical Area at 12 and 24 Weeks Postoperatively; | — |
Countries
China
Contacts
Public ContactPan Jian
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed