None
Conditions
Interventions
Test group:Oral absorbable biofilm
Control Group:Bio-Gide Resorbable Collagen Membrane
Sponsors
Hospital of Stomatology Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: All patients participating in this trial must meet the following inclusion criteria: 1. Age between 18 and 70 years old (inclusive), with no gender restrictions; 2. Patients with a single missing tooth that has adjacent teeth for reference and requires dental implant restoration; 3. Patients with insufficient alveolar bone volume at the site to be restored (excluding cases with only buccal and palatal bone volume insufficiency), who need guided bone tissue regeneration during the implant procedure; 4. Patients who voluntarily participate in the clinical trial and sign the "Informed Consent Form".
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be allowed to participate in this trial: 1. Patients with a history of preservation of alveolar bone sites in the tested tooth position; 2. Adjacent teeth with metal piles, nucleus, crown restorations or metal implants; 3. Patients with bone metabolic diseases (such as: osteoporosis, osteitis malformations, etc.), or have taken drugs or products that can significantly affect bone metabolism within 1 month before enrollment; 4. Patients who have received or are receiving radiotherapy or chemotherapy in the past 3 years; 5. Patients who need to use a combination of autologous bone or other bone substitute products provided by non-clinical trials, and patients who need to use other surgical bone augmentation techniques other than GBR; 6. Patients with uncontrolled or poorly controlled periodontal disease, acute infection in the oral cavity, etc.; 7. Patients with poor oral environment and unable to maintain good oral hygiene care; 8. Patients who cannot undergo oral imaging examinations, which affects the outcome assessment; 9. Patients with severe heart disease, abnormal coagulation function, etc., which are judged by the investigator to be unsuitable for surgery; 10. Patients with abnormal liver and kidney function (ALT and AST values exceeding 3 times the upper limit of normal, or creatinine exceeding 1.5 times the upper limit of normal); 11. Patients with poorly controlled diabetes mellitus (fasting blood glucose value exceeding 1.5 times the upper limit of normal) and poorly controlled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 12. Women of childbearing age and lactating women who are pregnant or intending to become pregnant; Male patients whose spouse intends to become pregnant; 13. Patients who smoke a lot (>=10 cigarettes/day); 14. Patients with severe mental illness; 15. The patient has participated in or is participating in other drug or device clinical trials in the past 3 months; 16. Patients who are unable to complete the follow-up required by the study; 17. Other patients who are judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of average thickness of alveolar bone on labial and buccal side of implant; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing of gingival tissue in the implanted area; | — |
Countries
China
Contacts
Public ContactZhang Yufeng
Hospital of Stomatology Wuhan university
Outcome results
None listed