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

University of Granada (UGR)

Status

Completed

Conditions

Sinus Floor Augmentation

Treatments

Device: Biphasic phycogenic biomaterial

Device: Xenograft bovine hydroxyapatite

Study type

Interventional

Funder types

Other

Identifiers

NCT03682315

307CEIH2017

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Partially edentulous patients.
Kennedy class I in the upper jaw.
Less than 5 mm of residual crestal bone to the maxillary sinus.
Need for the replacement of teeth with dental implants.

Exclusion criteria

Sinus pathology (sinusitis, mucocele, cysts).
Smokers.
Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.