Sinus Floor Augmentation Clinical Trial
Official title:
Sinus Floor Elevation Using Particulate and in Situ Hardening Biphasic Calcium Phosphate Bone Graft Substitutes: A Prospective Histological and Radiological Study
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.
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