Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo1 site in 1 country24 target enrollmentMay 4, 2020

Overview

A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure.

Registry

clinicaltrials.gov

Start Date

May 4, 2020

End Date

January 1, 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Sponsor

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Responsible Party

Principal Investigator

Luigi Canullo

Dr Luigi Canullo, DDS, Ph.D

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

•Patient requiring vertical elevation of the maxillary sinus.
•Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of \> 4-5mm.
•Males and females between 30-80 years old
•Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
•Patients that are willing to sign an informed consent and participate in a clinical study
•Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
•Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.

•Patients who smoke over 5 cigarettes/day
•Pregnancy (confirmed by verbal inquiry)
•Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District
•Patients taking bisphosphonates
•Any sites where an implant already failed sites
•Untreated Periodontitis
•Dental sites with acute infections
•Chronic inflammatory diseases of the oral cavity
•Autoimmune diseases (cortisone intake)
•Allergy declared to one or more medicaments to be used during treatment