Research on the application of resorbable biological membrane-Bonamem™ Collagen Membrane for alveolar bone defect repair. Oral Health
Conditions
Interventions
Informed consent will be obtained from all participants prior to enrollment.This is a prospective, multicenter, randomized, active-controlled, non-inferiority clinical trial conducted at 5 clinical ce
Sponsors
Bonanga Technology Tianjin Co.,Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in the trial and signs a written informed consent form; 2. Aged between 18 and 65 years old (including 18 and 65 years old), with no gender restrictions; 3. Cases with alveolar bone defects in the socket wall, with the maximum vertical height of the bone defect =5mm after tooth extraction; or cases with normal mesiodistal alveolar bone height of the second molar and a distal alveolar defect =5mm after extraction of the third molar; 4. At least one healthy adjacent tooth on one side.
Exclusion criteria
Exclusion criteria: 1. Bone defects caused by invasive or malignant bone tumors; 2. Patients with osteoporosis or osteomalacia; 3. Individuals with a specific allergic constitution, especially those sensitive to collagen; 4. Those who refuse to use pig-derived medical products; 5. Pregnant or nursing women and those planning to become pregnant during the study period; 6. Individuals with contraindications for oral surgery; 7. Those with systemic diseases that may affect the postoperative healing period and/or osseointegration, such as diabetes (fasting blood glucose =8 mmol/L), uncontrolled hypertension (systolic =160 mmHg and/or diastolic =100 mmHg), thyroid diseases, etc.; 8. Systemic or local bone diseases, such as tuberculosis, osteomyelitis, bone tumors, etc.; 9. Individuals with apical lesions in adjacent teeth in the surgical area, or those with apical cysts; 10. Individuals with uncontrolled systemic infections; 11. Severe hematological disorders, such as leukemia or other bleeding disorders; 12. Abnormal coagulation function (e.g., Prothrombin Time (PT) prolonged or shortened by >3 seconds, Activated Partial Thromboplastin Time (APTT) prolonged or shortened by >10 seconds, Platelet count (PLT) 1.5 ULN, or creatinine =1.5 times ULN); 18. Alcohol abusers, drug addicts, or those with a tendency to addiction; 19. Individuals who smoke more than ten cigarettes per day; 20. Individuals in the acute phase of Hepatitis B infection; 21. Individuals with positive initial screening for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis C antibodies, or Treponema pallidum-specific antibodies; 22. Individuals who have participated in other clinical trials within 3 months prior to the start of this trial; 23. Individuals with mental abnormalities and no capacity for autonomous behavior; 24. Individuals whom the investigator deems unsuitable to participate in this clinical trial for other reasons.
Countries
China
Contacts
Public ContactZhixu Jiang
Outcome results
None listed