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

Not Applicable

Completed

• Conditions: Sinus Floor Augmentation
• Interventions: Device: ABB+ACB; Device: PBM+ACB

• Registration Number: NCT03797963
• Lead Sponsor: Universidad de Granada

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-06
• Study Start: 2019-01-08
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-09
• Primary Completion: 2021-02-02
• Study Completion: 2022-02-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-20
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABB+ACB	ABB+ACB	Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone
PBM+ACB	PBM+ACB	Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone

Primary Outcome Measures

Name	Time	Method
Sinus floor height change	From surgery to 6 months	CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change

Secondary Outcome Measures

Name	Time	Method
Area of remaining graft particles	6 months	Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure
Sinus floor height change after 18 months	From surgery to 18 months	CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change
Area of new mineralized tissue	6 months	Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
Sinus floor height change after 12 months	From surgery to 12 months	CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change
Area of non-mineralized tissue	6 months	Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure

Trial Locations

Locations (1)

Universidad de Granada; 🇪🇸 Granada, Spain