Regenetate mandibular defect or insufficient amount of bone
Conditions
Interventions
Control versus Experimenta:Bio-Gide versus Guide Tissue Regeneration Membrane
Sponsors
Hospital of Stomatology Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patients must meet the following ctriteria: 1. Patients with mandibular bone defects need for surgical indications; 2. Bone defect bone wall should be at least one wall; 3. Males and females, 18 years to 75 years of age; 4. Patients didn't participate in the other clinical trials three months before; 5. Females of childbearing potential must have a documented negative urine pregnancy test. All subjects must agree to use acceptable methods of contraception for the duration of the study; 6. Patients must have read, understood, and signed the informed consent.
Exclusion criteria
Exclusion criteria: Patient meets one of the following criteria will be excluded from this test: 1. Patients have serious heart, liver, lung, kidney and other vital organs, or severe blood diseases, immune, endocrine (eg: uncontrolled diabetes) and other systemic diseases; 2. Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit; 3. Patients have bone metabolic diseases (ie, osteoporosis or Paget's disease), or use of any substance or medication that will influence bone metabolism (e.g. corticosteroids, bisphosphonates); 4. Patient who is a heavy smoker (>10/cigarettes per day) during the 6 months preceding this study; 5. Alcoholism or chronically drug abuse; 6. Current pregnancy or breastfeeding women; 7. Allergic constitution, have allergies or other serious allergic reaction to collagen past history; 8. Mental disease or mental abnormalities; 9. Poor compliance, cann't be completed on schedule followed up; 10. Require the joint use of other surgical bone augmentation techniques other than those GBR; 11. Need to mix with autogenous bone or other bone replacement products; 12. Severe periodontal disease, and can not be effectively controlled; 13. Oral inflammation, infection can not be controlled; 14. Previous history of irradiation of the head and neck area; 15. Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene; 16. Patients, who in the opinion of the Principal Investigator, for any reason other than those listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mass; | — |
Countries
China
Contacts
Public ContactShi Bin
Outcome results
None listed