Sinus Floor Augmentation Clinical Trial
Official title:
Algae-derived Hydroxyapatite Behaviour as Bone Biomaterial in Comparison to Anorganic Bovine Bone. A Randomised Split-mouth Human Study.
NCT number | NCT03682315 |
Other study ID # | 307CEIH2017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | May 2018 |
Verified date | May 2023 |
Source | Universidad de Granada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | May 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Facultad de Odontología | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
Galindo-Moreno P, Padial-Molina M, Lopez-Chaichio L, Gutierrez-Garrido L, Martin-Morales N, O'Valle F. Algae-derived hydroxyapatite behavior as bone biomaterial in comparison with anorganic bovine bone: A split-mouth clinical, radiological, and histologic — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sinus floor height change | CBCT scans are performed before the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus | From surgery to 6 months | |
Secondary | Area of new mineralized tissue | Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure | 6 months | |
Secondary | Area of non-mineralized tissue | Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure | 6 months | |
Secondary | Area of remaining graft particles | Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure | 6 months |
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