Evaluation of OSSIX® Bone in Sinus Elevation

Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation

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

Study Overview

• Status: Completed
• Conditions: Maxillary Sinus Floor Augmentation
• Intervention / Treatment: Device: OSSIX Bone

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that need sinus elevation

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who smoke over 5 cigarettes/day
2. Pregnancy (confirmed by verbal inquiry)
3. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
4. Patients taking bisphosphonates
5. Any sites where an implant already failed sites
6. Untreated Periodontitis
7. Dental sites with acute infections
8. Chronic inflammatory diseases of the oral cavity
9. Autoimmune diseases (cortisone intake)
10. Allergy declared to one or more medicaments to be used during treatment
11. Alcoholics patients and/or drug addicts
12. Patients with known collagen hypersensitivity.
13. Patients with sensitivity to porcine-derived materials.
14. History or malignant tumours of the maxillary sinus
15. History of local radiation therapy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in Bone height from baseline	1 year
Difference in bone volume	1 year

Collaborators and Investigators

• Sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
• Investigators: Principal Investigator: Luigi Canullo, DDS, PhD, Study Site

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2020
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (ACTUAL): May 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No