his product can be used for the repair and treatment of periodontal or alveolar bone soft and hard tissues, acts as a physical barrier, or works with bone repair materials to guide the regeneration of
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and signing of informed consent; 2. There are indications for dental implants and insufficient bone mass, and GBR technique is needed for bone increment; 3. There is at least one adjacent tooth; 4. Aged 18 to 65 years old male and female; 5. Single patient treatment during this clinical study; 6. Can cooperate with this test plan and receive regular visits after surgery.
Exclusion criteria
Exclusion criteria: 1. Subjects that do not meet the need for bone-incremental surgery alone; 2. Subjects with severe systemic disease (researcher's decision); 3. Those who are allergic to collagen (inquiry about medical history); 4. Hypertensive and diabetic subjects whose condition cannot be stably controlled (researcher's judgment); 5. A subject with a history of head and neck radiotherapy; 6. Subjects with a history of bone diseases such as osteoporosis and bone tumors (inquiry history); 7. Long-term use of non-steroidal anti-inflammatory drugs, bisphosphonates, corticosteroids, tetracyclines, immunosuppressants and other drugs that affect bone metabolism or bone healing; 8. Pregnant or lactating women, as well as male and female subjects scheduled to conceive during the trial; 9. Subjects with significant ectopic and torsional teeth and adjacent teeth; 10. a subject with a apical lesion in the bone graft or adjacent teeth; 11. Subjects with acute infection in the bone graft area; 12. Subjects whose blood routine, blood biochemistry (except creatinine) is less than 50% of the lower limit of the reference value or 50% above the upper limit of the reference value; 13. Subjects that other investigators believe cannot be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental changes in alveolar bone width; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incremental changes in alveolar bone width;Bone density assessment;New bone contour evaluation;Wound soft tissue healing evaluation; | — |
Countries
China
Contacts
Beijing Chao-yang Hospital of Capital Medical University