The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using two different xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor elevation. A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of autogenous cortical bone (collected by a bone scraper from the access window to the maxillary sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core biopsies will be obtained at the site of implant placement 6 months after the floor elevation. Histological sections will be subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone
Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone
Universidad de Granada
Granada, Spain
Sinus floor height change
CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change
Time frame: From surgery to 6 months
Sinus floor height change after 12 months
CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change
Time frame: From surgery to 12 months
Sinus floor height change after 18 months
CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change
Time frame: From surgery to 18 months
Area of new mineralized tissue
Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Time frame: 6 months
Area of non-mineralized tissue
Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Time frame: 6 months
Area of remaining graft particles
Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure
Time frame: 6 months
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