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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBM+ACB | Active Comparator | Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone |
|
| ABB+ACB | Experimental | Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBM+ACB | Device | Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Galindo-Moreno, DDS, MS, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Granada | Granada | 18071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29071736 | Background | Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26. | |
| 17355356 |
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| ABB+ACB | Device | Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone |
|
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 |
| Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12. |
| 35224778 | Result | Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3. |