Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration

Launched by BONUSBIO GROUP LTD · Jun 2, 2014

Keywords

ClinConnect Summary

Primary endpoint: The implantation of BonoFill 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 implantation of BonoFill to the maxillary or mandible void is efficient under the following conditions: Following BonoFill 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:
• The inclusion criteria defining the eligible subjects are divided to two groups according clinical indications:
• • Sinus augmentation
• • Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
• • Subjects that have a rehabilitation dentist and rehabilitation program
• • Up to dated panoramic X-Ray.
• • Subjects who provided written informed consent to participate in the study, able to understand study procedure and agree for follow up procedures
• • Healthy conditions of Maxillary Sinuses and Oral Mucosa.
• • Sub-antral bone at least 4 mm as measured on CBCT/CT.
• • Have a good oral hygiene condition as per investigator discretion.
• • Bone grafting after removal of cysts from jaws
• • Healthy subject.
• • Subjects that have a rehabilitation dental treatment.
• • Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
• • Subjects referred to oral \& maxillofacial Dpt for removal of cysts after diagnosis of the cyst type.
• • Healthy bone determined by X-ray.
• • Have a good oral hygiene condition.
• • Subject that does not participate in other clinical study.
• • Subject able to read and understand and sign the informed consent
• Exclusion Criteria:
• • Subjects with recorded medical history diseases as: diabetes mellitus, heart diseases, renal failure, osteoporosis.
• • Subject treated with systemic steroid treatment
• • Subjects with known autoimmune diseases, such as: Addison's disease Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome Systemic lupus erythematosus, Type I diabetes.
• • Subjects that have Vitiligo and/or known scar healing problems (keloid formation).
• • Subjects treated with anticoagulation medication (such as Coumadin, Plavix and other similar medications)
• • Subjects treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
• • Subjects with a history of Chemotherapy or Radiotherapy treatment
• • In case of sinus augmentation - Unhealthy conditions of Maxillary Sinuses.
• • Subjects with current active infection or illness
• • Subjects participating in another clinical trial 30 days prior to and during the study period
• • Pregnant or lactating woman. Pregnancy will be verified by urine test during screening
• • Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation
• • Subjects with any known allergy for anesthesia
• • Positive serology for either HIV, hepatitis B or hepatitis C
• • Abnormal clinically significant as per investigator's judgment laboratory test and exams findings