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

Sinus Floor Augmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797963
• Other study ID #: 480CEIH2018
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: February 27, 2022

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 27, 2022
• Est. primary completion date: February 2, 2021
• 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:
• PBM+ACB
Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone
• ABB+ACB
Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone

Locations

Country	Name	City	State
Spain	Universidad de Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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 con — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
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