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

NCT03797963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-05-23

No results posted yet for this study

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.

Conditions

  • Sinus Floor Augmentation

Interventions

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

DEVICE

ABB+ACB

Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Principal Investigators

  • Pablo Galindo-Moreno, DDS, MS, PhD · Universidad de Granada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2021-02-02
Completion
2022-02-27

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03797963 on ClinicalTrials.gov