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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Enrollment
27
Sinus augmentation - Surgery will be performed by either open or close sinus augmentation as per investigator discretion and as per common medical practice. After the elevation, BonoFill-II will be transplanted on the residual sub-antral bone. Bone grafting after removal of cysts from jaws - Treatment will be performed according to the size of the cyst: in relatively small cyst total enucleation will be performed. In large cysts, a process of marsupialization will be performed. The entire cyst will be removed, including the epithelium layer, and the BonoFill-II product will be used for filling.
Oral and Maxillofacial Surgery Clinic - Beit Merik
Kfar Saba, Israel
Safety of Bonofill-ll Administration
The study will assess the safety of the BonoFill-II drug product post transplantation by demonstrating No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.
Time frame: 6-month clinical Follow Up
Efficacy of Bonofill-ll Administration
Following BonoFill-II transplantation, the bone regeneration in the operated site will be evaluated using CT or panoramic X Ray. Bone formation at the implantation site inside the maxillary sinus will be evaluated by measuring the bone height at the end of the study (residual + Augmented bone at 3 evenly-spaced locations). Successful bone regeneration is achieved if: * Bone formation inside the maxillary sinus or bone void, in the area of dental implantation defined at Visit 1 (prior to BonoFill-ll transplantation), with average height (residual + augmented bone) of at least 8mm, OR * Bone formation inside the maxillary sinus in the area of dental implantation defined at Visit 1 (prior to BonoFill-II transplantation), allowing successful dental implantation.
Time frame: 6-month clinical Follow Up
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