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NCT03797963

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

Completed NA Last updated 23 May 2023
What this trial tests

NA trial testing PBM+ACB in Sinus Floor Augmentation in 10 participants. Completed in 27 February 2022.

Timeline
8 January 2019
Primary endpoint
2 February 2021
27 February 2022

Quick facts

Lead sponsorUniversidad de Granada
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment10
Start date8 January 2019
Primary completion2 February 2021
Estimated completion27 February 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Universidad de Granada — full company profile →

Who can join

18 and older, any sex, with Sinus Floor Augmentation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial.
    Galindo-Moreno P, Abril-García D, Carrillo-Galvez AB, Zurita F, et al · · 2022 · cited 29× · PMID 35224778 · DOI 10.1111/clr.13912
  2. Bone Regeneration Using Mesenchymal Stromal Cells and Biocompatible Scaffolds: A Concise Review of the Current Clinical Trials.
    Re F, Borsani E, Rezzani R, Sartore L, et al · · 2023 · cited 21× · PMID 37232981 · DOI 10.3390/gels9050389

Verify or expand the search:

Other recruiting trials for Sinus Floor Augmentation

Currently open trials in the same condition.

Other Universidad de Granada trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03797963.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing