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| Name | Class |
|---|---|
| University of Valencia | OTHER |
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The study aims to investigate the radiological and histomorphometric results of the use of PLGA-coated biphasic calcium phosphate granules in sinus floor elevation, to analyze the underlying molecular processes by immunohistochemical staining, and to evaluate the handling of the biomaterial and the in situ hardening properties.
A randomized clinical study is designed to include patients in need of two-stage sinus floor elevation. Patients are assigned to receive either PLGA-coated biphasic calcium phosphate particles (group I) or the equivalent but non-coated particles (group II). CBCT scans are performed before and 6 months after the procedure to assess the bone height gain. At the time of implant placement, bone core biopsies are obtained at the site of implant placement. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-coated HA/TCP particles | Active Comparator | Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft |
|
| PLGA-coated HA/TCP particles | Experimental | Biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-coated HA/TCP particles | Device | Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sinus floor height change | CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to measure vertical bone height from the crestal bone to the floor of the maxillary sinus. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio J Flichy-Fernandez, DDS | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada | Granada | 18071 | Spain | |||
| Universidad de Valencia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22376122 | Background | Galindo-Moreno P, Hernandez-Cortes P, Mesa F, Carranza N, Juodzbalys G, Aguilar M, O'Valle F. Slow resorption of anorganic bovine bone by osteoclasts in maxillary sinus augmentation. Clin Implant Dent Relat Res. 2013 Dec;15(6):858-66. doi: 10.1111/j.1708-8208.2012.00445.x. Epub 2012 Feb 29. | |
| 28854415 | Background |
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| PLGA-coated HA/TCP particles | Device | Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating |
|
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 |
| Valencia |
| 46010 |
| Spain |
| Ortega-Oller I, Del Castillo-Santaella T, Padial-Molina M, Galindo-Moreno P, Jodar-Reyes AB, Peula-Garcia JM. Dual delivery nanosystem for biomolecules. Formulation, characterization, and in vitro release. Colloids Surf B Biointerfaces. 2017 Nov 1;159:586-595. doi: 10.1016/j.colsurfb.2017.08.027. Epub 2017 Aug 24. |
| 17355356 | Background | 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. |
| 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. |