NCT03682315

Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation

Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sinus Floor Augmentation

Interventions

Type	Name	Description
DEVICE	Biphasic phycogenic biomaterial	Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone
DEVICE	Xenograft bovine hydroxyapatite	Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-04-01
• Completion: 2018-05-01
• First posted: 2018-09-24
• Last updated: 2023-05-23

Locations

1 site across 1 country: Spain