Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration (NCT02842619) | Clinical Trial Compass
CompletedPhase 1/2
Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration
Israel27 participantsStarted 2016-07-23
Plain-language summary
The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived cells in reconstructing bone in two clinical indications:
1. Bone augmentation (e.g. sinus augmentation)
2. Bone grafting after removal of cysts from jaws
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. The subjects requires sinus augmentation as per investigator's discretion
✓. Healthy condition of Maxillary Sinuses and Oral Mucosa determined by X-ray
✓. 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.
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.