Oral planting
Conditions
Interventions
Experimental group:Soft tissue patch
control group:Absorbable biofilm
Sponsors
The Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 years or above and <= 70 years old, regardless of gender; 2. Patients with single missing maxillary anterior teeth and premolars who need delayed implant restoration (the interval between tooth extraction and implant is at least 2 months); 3. Subjects who need GBR technology to supplement bone mass due to insufficient alveolar bone mass in clinical diagnosis repair site; 4. Voluntarily participate in clinical trials and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with apical disease near the operation area, or patients with apical cyst near the operation area; 2. Patients with uncontrollable periodontal disease of adjacent teeth and advanced periodontal disease; 3. Patients with oral mucosal diseases such as oral leukoplakia, oral Behcet's disease, etc; 4. Patients with other contraindications of oral surgery; 5. Patients with systemic diseases that may affect postoperative healing and / or osseointegration, such as diabetic patients with poor control (fasting blood glucose >= 11.1mmol/l), chondropathy, systemic or local bone diseases, such as bone tuberculosis, osteoarthritis, bone tumor, etc; 6. Patients with severe hematological diseases, such as leukemia or other hemorrhagic diseases (prothrombin time prolongation > 6 seconds); 7. Patients with uncontrolled infection in the whole body; 8. Patients with history of radiotherapy or chemotherapy for head and neck in recent 3 years, or patients undergoing radiotherapy or chemotherapy; 9. Patients who are taking or long-term taking special drugs that may affect postoperative healing or osseointegration (such as diphosphate drugs and high-dose adrenocortical hormone); 10. Patients with severe cardiac, hepatic and renal insufficiency were defined as: Cardiac function: Grade III and above; ALT or ast > 2.5 times the upper limit of normal value; Serum creatinine > 2.5 times the upper limit of normal value. 11. Patients with specific allergic constitution, such as collagen allergy and metal allergy; 12. Subjects who could not accept pig derived instruments due to religious and ethnic problems; 13. Subjects who have participated in clinical trials of other drugs or medical devices in the last 6 months; 14. Subjects with various malignant tumors and chronic wasting diseases causing cachexia and unable to tolerate surgery; 15. Pregnant or planned pregnant women and lactating women; 16. Subjects with mental disorders and no ability of behavioral autonomy; 17. Other circumstances in which doctors judge that they cannot participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of mean alveolar bone thickness (including alveolar bone thickness and bone implant powder thickness) at 6 months postoperatively; | — |
Countries
China
Contacts
Public ContactHongchang Lai
The Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed