Bone defect
Conditions
Interventions
Test group:Bone Graft Material + Geistlich Bio-Gide
Control group:Bone Filling Material + Geistlich Bio-Gide
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: An individua had to meet all of the following criteria: 1. Age 18-65 years old (including 18 years old and 65 years old), regardless of gender; 2. Single tooth extraction caused bone defect requiring bone graft; 3. The tooth to be extracted has at least one adjacent tooth; 4. Be able to understand the purpose of the trial, voluntarily participate in the study, and be willing to sign written informed consent.
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Bone defect caused by aggressive or malignant bone tumors; 2. Periodontitis, acute apical periodontitis, osteomyelitis and other infectious diseases without treatment control at the surgical site; 3. Incomplete debridement of necrotic tissue (if any) around the tooth to be extracted; 4. Drugs that may affect or promote bone metabolism (glucocorticoids, bisphosphonates, etc.) were taken within 3 months before or during the screening period; 5. Have a disease that may affect bone metabolism, such as: Uncontrolled diabetes (fasting blood glucose =8.0 mmol/L after treatment), osteoporosis, osteomalacia, liver/kidney dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2×ULN, serum creatinine (Cr) > 1.5×ULN); 6. Patients with cardiac insufficiency (NYHA class ? or above), or uncontrolled hypertension (systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg); 7. Patients with abnormal coagulation function, bleeding diseases, or use of anticoagulants (such as heparin, warfarin, etc.) or antiplatelet drugs (such as aspirin, clopidogrel, etc.) within 14 days before the screening period or plan to use during the study; 8. Patients with severe autoimmune diseases, hematological diseases, or cerebrovascular diseases; 9. Patients with a history of or undergoing radiotherapy or chemotherapy for the head and neck; 10. Patients with mental disorders without behavioral autonomy (such as autism spectrum disorder, bipolar disorder, schizophrenia, depression, etc.); 11. Those who are known to be allergic or hypersensitive to porcine/bovine fillers or chitosan; 12. Those who refuse to use medical products of porcine origin; 13. The adjacent teeth of the extraction site may cause artifacts in oral imaging examination, such as metal dentures or porcelain teeth, which may cause artifacts in oral imaging examination; 14. Pregnant or lactating women, or those planning to become pregnant within 6 months; 15. Smoking more than 5 cigarettes per day in the 3 months before the screening period; 16. Persons who are addicted to alcohol, drugs or other substances or are prone to addiction; 17. Participants who have participated or are participating in a drug clinical trial within 3 months before the screening period, or who have participated or are participating in a clinical trial of another medical device within 30 days before the screening period; 18. Other circumstances that the investigator considered inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of alveolar ridge height from baseline to 24 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of alveolar ridge width from baseline to 24 weeks after surgery;The fusion of the alveolar fossa bone graft site with the alveolar fossa bone wall was observed at 24 weeks after surgery;Wound Healing;Rejection;Device Performance Evaluation; | — |
Countries
China
Contacts
Public ContactJian Pan
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed