Split-mouth Randomized Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sinus Floor Augmentation
- Sponsor
- Universidad de Granada
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Sinus floor height change
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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 two different xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor elevation.
A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of autogenous cortical bone (collected by a bone scraper from the access window to the maxillary sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core biopsies will be obtained at the site of implant placement 6 months after the floor elevation. Histological sections will be subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
Investigators
Pablo Galindo-Moreno
Full Professor
Universidad de Granada
Eligibility Criteria
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).
- •Previous long-term (\>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.
Outcomes
Primary Outcomes
Sinus floor height change
Time Frame: From surgery to 6 months
CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change
Secondary Outcomes
- Area of remaining graft particles(6 months)
- Sinus floor height change after 18 months(From surgery to 18 months)
- Area of new mineralized tissue(6 months)
- Sinus floor height change after 12 months(From surgery to 12 months)
- Area of non-mineralized tissue(6 months)