alveolar bone site preservation after tooth extraction
Conditions
Interventions
Experimental Group:Implant OCS-B Collagen
Control Group:Implant Geistlich Bio-Oss Collagen
Sponsors
Hospital of Stomatology Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male or female between 18~65 (inclusive); 2.Patient undergoing single tooth extraction cases with normal alveolar ridge height of neighboring teeth on at least one side; 3.Patient’s X-ray image shows bone defect in the alveolar bone wall of the affected tooth and the vertical height of the wall with the largest bone defect is >=5 mm as determined by the investigator; or if a third molar is to be extracted for a variety of reasons, X-ray image shows a normal proximal mesial alveolar ridge height in the second molar and a distal mesial alveolar ridge defect of >=5 mm as determined by the investigator; 4.Patients willing and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with periodontal tissue inflammation in the acute stage; 2. Patients with various bone defects attributed to invasive or malignant bone tumors; 3. Patients with various bone defects arising from acute infectious lesions or metabolic bone diseases in the active stage; 4. Patients with osteomyelitis, osteoporosis, osteomalacia; 5. Patients with Class II or higher cardiac function disease; 6. Patients with poorly controlled diabetes (fasting blood glucose >=8.0 mmol/L) or with poorly controlled hypertension [systolic blood pressure >180 mmHg and diastolic blood pressure >110 mmHg] under treatment with appropriate doses of more than 3 antihypertensive drugs]; 7. Patients with allergic physique (known allergy to two or more drugs or food); 8. Patients with mental abnormality and without behavioral autonomy (e.g., autism spectrum disorder, bipolar disorder, schizophrenia, depression, etc.); 9. Patients with a history of hyperparathyroidism that has not been controlled by treatment or is currently poorly controlled; 10. Patients with a history of autoimmune disease or currently suffering from autoimmune disease; 11. Patients with heavy smoker (>20 cigarettes/day); 12. Patients with known bleeding disorders or under medication that affects blood clotting (e.g. aspirin, clopidogrel bisulfate, warfarin, heparin drugs, etc.); 13. Patients with abnormal liver or renal function (ALT, AST > 2 *ULN, creatinine > 1.5 * ULN), blood calcium or blood phosphorus exceeding the normal range; 14. Patients with various kinds of conditions in the target area that may lead to artifacts in oral image (e.g., metal denture, porcelain teeth, etc.); 15. Patients who are undergoing or have recently had a history of head and neck radiotherapy; 16. Patients who are receiving or have recently received medications that may affect or promote bone metabolism; 17. Patients who have participated in any clinical trials within 3 months prior to the start of this trial; 18. Patients who cannot accept materials of porcine or bovine origin; 19. Female who are pregnant, breastfeeding, or have plans to become pregnant within six months; 20. Patient with any condition which, determined by the investigator is unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imageology diversity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical surgical incision healing evaluation;Rejection reaction;Bone metabolism;Bone infection; | — |
Countries
China
Contacts
Public ContactJihong Zhao
Hospital of Stomatology Wuhan University
Outcome results
None listed