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

Safety 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.

Efficacy endpoint:

The transplantation of BonoFill-II to the maxillary or mandible void is efficient: the bone defects/voids are filled with at least 8mm of total bone height at the transplanted area.

Inclusion criteria

GENERAL

• Subject in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
• Subject has a rehabilitation dentist and rehabilitation program
• Up to date panoramic X-Ray/CT
• Subject has provided written informed consent to participate in the study, understands all study procedures and agrees to follow up procedures
• Subject is in good oral hygiene condition as per investigator's discretion

SINUS AUGMENTATION

• The subjects requires sinus augmentation as per investigator's discretion
• Healthy condition of Maxillary Sinuses and Oral Mucosa determined by X-ray

BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS

• 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.
• Subject's cyst was removed after diagnosis of the cyst type

Exclusion criteria

• Subject with a recorded medical history of diseases such as diabetes mellitus, heart diseases, renal failure, osteoporosis, Multiple sclerosis,
• Subject treated with systemic steroids
• 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.
• Subject has vitiligo or a known scar healing problems (keloid formation)
• Subject treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
• Subjects underwent one of the following treatments up to 12 months prior to Visit 1: Chemotherapy, Radiotherqapy
• In case of sinus augmentation - unhealthy conditions of Maxillary Sinuses.
• Subject with current active infection or illness.
• Subject participating in another clinical trial 30 days prior to and during the study period.
• Subject is a pregnant or lactating woman. Pregnancy will be verified by urine test during screening.
• Subject has a known history of any significant medical disorder, which in the investigator's discretion contraindicates the subject's participation.
• Subject has a known allergy for anesthesia.
• Subjects with known allergy to hyaluronic acid.
• Subjects with known allergy to HypoThermosol® or Dextran-40.
• Subjects with known allergy to any of the antibiotics: Bacitracin, Gentamicin and/or Polymyxin B Sulfate.
• Positive serology for either HIV, hepatitis B or hepatitis C.
• Abnormal clinically significant laboratory test and exams findings as per investigator's discretion.