None listed
Conditions
Interventions
Experimental group :Lando oral bone repair material, Lando oral resorbable biofilm
Control group:Geistlich Bio-Oss, Lando oral resorbable biofilm
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~65 years; 2. Subjects who need bone grafting for alveolar ridge site preservation after extraction of incisor teeth, cusp teeth and premolars (adjacent teeth in good condition **), who need oral bone defect repair with absorbable oral membrane, and who need repair 26 weeks after extraction; 3. Volunteer to participate in the clinical trial and sign the informed consent. Note * : The subject is at least 18 years old and under 66 years old when the informed consent is signed. Note ** : The adjacent tooth is intact, i.e. the adjacent tooth has no lesions or prostheses that may affect the healing of the operative area or affect the measurement of the results.
Exclusion criteria
Exclusion criteria: 1. Those who have participated in other clinical trials within 90 days* prior to the start of this trial; 2. Those who have received and/or need to receive radiation therapy or chemotherapy to the head or neck during the study period; 3. Those who have received and/or need to receive during the study period medications that may affect or promote bone metabolism within 90 days prior to the start of the trial*, including calcitonin, parathyroid hormones, bisphosphonates, high-dose prolonged steroid hormones, immunosuppressive drugs, antidepressants, and other drugs that the investigator believes may affect bone metabolism; Note: High-dose prolonged steroid hormone analogues are defined as oral dexamethasone over 40 mg/day and used for more than 4 consecutive days; or intravenous dexamethasone over 200 mg/day and used for more than 2 consecutive days; or equal doses of other steroid hormone analogues. 4. Patients with severe cardiac disease (i.e., New York Heart Assignment (NYHA) class II and above); 5. Patients with abnormal liver and kidney function (ALT, AST more than 3 times the normal value; creatinine, urea nitrogen more than the normal range value and judged by the investigator to be clinically significant); 6. Those with poorly controlled diabetes (fasting blood glucose still >= 7.0 mmol/L by drug control, or random blood glucose >= 11.1 mmol/L, or glycosylated hemoglobin (HbA1c) >= 6.5%) 7. HIV-infected patients; 8. Patients with bleeding tendency or coagulation disorders: abnormal platelet count, abnormal coagulation function (prothrombin time (PT), activated partial thromboplastin time (APTT)), international normalized ratio (INR), fibrinogen (FIB), and who are considered clinically significant by the investigator; 9. Mentally abnormal incapacitated patients; 10. Pregnant patients; 11. Patients who are breastfeeding or preparing for pregnancy within the next 26 weeks**; 12. Heavy smokers (10 or more cigarettes per day); 13. Patients with periodontal disease without basic periodontal treatment; 14. Those with greater than two-thirds loss of bone wall on either side of the alveolar fossa; 15. Other patients who are considered by the investigator to be unsuitable for this trial. Note*: The start time here refers to the time when the subject signed the informed consent form. Note**: Refers to women who are planning a pregnancy within 26 weeks from the start of study product use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alveolar ridge width change values; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alveolar ridge height change values;Postoperative healing of surgical incisions; | — |
Countries
China
Contacts
Public ContactWu Yiqun
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed