Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation

Study Overview
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Brief Summary
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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.

Official Title
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Split-mouth Randomized Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation

Conditions
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Sinus Floor Augmentation

Intervention / Treatment
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* Device: PBM+ACB
* Device: ABB+ACB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PBM+ACB<br>Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone | Device: PBM+ACB<br>* Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone<br>|
| Experimental: ABB+ACB<br>Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone | Device: ABB+ACB<br>* Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus floor height change | CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change | From surgery to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus floor height change after 12 months | CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change | From surgery to 12 months | 
| Sinus floor height change after 18 months | CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change | From surgery to 18 months | 
| Area of new mineralized tissue | Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure | 6 months | 
| Area of non-mineralized tissue | Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure | 6 months | 
| Area of remaining graft particles | Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillary sinus augmentation, Sinus lift, Biomaterial, Anorganic bovine bone, Porcine bone mineral, Implant dentistry