Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682315
• Other study ID #: 307CEIH2017
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Sinus Floor Augmentation

Intervention

Device:
• Biphasic phycogenic biomaterial
Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone
• Xenograft bovine hydroxyapatite
Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone

Locations

Country	Name	City	State
Spain	Facultad de Odontología	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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

Outcome

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