An interventional study of Biphasic phycogenic biomaterial and Xenograft bovine hydroxyapatite in Sinus Floor Augmentation, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment
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 a biphasic phicogenic biomaterial in comparison with anorganic bovine bone.
A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biphasic phycogenic biomaterial and Autogenous cortical bone
Device: Biphasic phycogenic biomaterial
Xenograft bovine hydroxyapatite and Autogenous cortical bone
Device: Xenograft bovine hydroxyapatite
Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone
Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone
Sinus floor height change
CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus
Time frame: From surgery to 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
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Universidad de Granada