Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration
Sponsored by BonusBio Group Ltd
About this trial
Last updated 8 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 9 years ago
What is this trial about?
What are the participation requirements?
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