Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration

Launched by BONUSBIO GROUP LTD · Jul 20, 2016

Keywords

ClinConnect Summary

Primary endpoint:

The transplantation of BonoFill-II to the maxillary or mandible defect/void is safe under the following conditions: No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.

Secondary endpoint:

The transplantation of BonoFill-II to the maxillary or mandible void is efficient under the following conditions: Following BonoFill-II implantation, the bone regeneration in the operated site was significantly accelerated. Also, the bone defects/voids were filled with a significant amount of bone tissue.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • GENERAL
• • 1. Subject in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
• • 2. Subject has a rehabilitation dentist and rehabilitation program
• • 3. Up to date panoramic X-Ray/CT
• • 4. Subject has provided written informed consent to participate in the study, understands all study procedures and agrees to follow up procedures
• • 5. Subject is in good oral hygiene condition as per investigator's discretion
• • SINUS AUGMENTATION
• • 1. The subjects requires sinus augmentation as per investigator's discretion
• • 2. Healthy condition of Maxillary Sinuses and Oral Mucosa determined by X-ray
• • BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS
• • 1. Subject who according to investigator diagnosis required removal of cysts from jaws. Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
• • 2. Subject's cyst was removed after diagnosis of the cyst type
• Exclusion Criteria:
• • 1. Subject with a recorded medical history of diseases such as diabetes mellitus, heart diseases, renal failure, osteoporosis, Multiple sclerosis,
• • 2. Subject treated with systemic steroids
• • 3. Subject with a known autoimmune disease, such as Addison's disease, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus, Type I diabetes.
• • 4. Subject has vitiligo or a known scar healing problems (keloid formation)
• • 5. Subject treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
• • 6. Subjects underwent one of the following treatments up to 12 months prior to Visit 1: Chemotherapy, Radiotherqapy
• • 7. In case of sinus augmentation - unhealthy conditions of Maxillary Sinuses.
• • 8. Subject with current active infection or illness.
• • 9. Subject participating in another clinical trial 30 days prior to and during the study period.
• • 10. Subject is a pregnant or lactating woman. Pregnancy will be verified by urine test during screening.
• • 11. Subject has a known history of any significant medical disorder, which in the investigator's discretion contraindicates the subject's participation.
• • 12. Subject has a known allergy for anesthesia.
• • 13. Subjects with known allergy to hyaluronic acid.
• • 14. Subjects with known allergy to HypoThermosol® or Dextran-40.
• • 15. Subjects with known allergy to any of the antibiotics: Bacitracin, Gentamicin and/or Polymyxin B Sulfate.
• • 16. Positive serology for either HIV, hepatitis B or hepatitis C.
• • 17. Abnormal clinically significant laboratory test and exams findings as per investigator's discretion.