The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties. A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft
Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating
University of Granada
Granada, Spain
Universidad de Valencia
Valencia, Spain
Sinus floor height change
CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to measure vertical bone height from the crestal bone to the floor of the maxillary sinus.
Time frame: 6 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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