A Phase I Study of SB Cell for the Enhanced Osseointegration of Guided Bone Regeneration in Implant Surgery

1. Subjects 20 years old and over;
2. Sign of informed consent form;
3. Patients with one missing tooth with D2, D3 bone density;
4. Gums environment defined as alveolar bone height of 10 mm and above, bone width 8 mm and above;
5. Have only one missing maxillary or mandibular posterior tooth (No. 4, 5, 6 or 7) who require a GBR prior to a dental implant.
6. Bone defect(s) must be present with at least two walls missing.
7. The opposing dentition must be nature teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed;
8. Subject is able to understand and comply with protocol requirements, instructions and protocol stated restrictions

Exclusion Criteria:

1. Patients who have inadequate organ function described as below:

   1. ANC \< 1.5 x 109/L
   2. Platelets \< 100 x 109/L
   3. Hb \< 9 g/dL
   4. Serum bilirubin \< 1.5 x the upper limit of normal (ULN)
   5. Aspartate aminotransferase (AST [SGOT]) \< 2.5 × the ULN
   6. Alanine aminotransferase (ALT [SGPT]) > 2.5 × the ULN
   7. Serum creatinine > 1.5 mg/dL or a measured creatinine clearance \< 60 mL/min;
2. History of neoplastic disease and had been treated with chemotherapy;
3. Uncontrolled Diabetes Mellitus;
4. Dialysis patients;
5. Patients with cardiovascular disease;
6. Osteoporosis patients and patients taking bisphosphonates;
7. History of radiation therapy to the head and neck;
8. Patients with temporomandibular disorder;
9. Pregnant or nursing women;
10. Presence of conditions requiring chronic routine prophylactic use of antibiotics (history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements);
11. Medical conditions requiring prolonged use of steroids;
12. Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
13. Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0;
14. Alcoholism or drug abuse;
15. Patients infected with HIV;
16. Current smokers, ;
17. Local inflammation, including untreated periodontitis;
18. Mucosal diseases such as erosive lichen planus;
19. History of local radiation therapy;
20. Presence of osseous lesions;
21. Unhealed extraction sites;
22. Persistent intraoral infection;
23. Patients with inadequate oral hygiene or unmotivated for adequate home care;
24. Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
25. Patient with a pathology present near the site of dental implantation.