Evaluation of OSSIX® Bone in Sinus Elevation

NCT04381455 | Completed FDA Device

• 1 other identifier: DD-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Maxillary Sinus Floor Augmentation

Outcome Measures

Primary Outcomes (2)

• Difference in Bone height from baseline

  1 year

• Difference in bone volume

  1 year

Interventions

OSSIX Bone DEVICE

subjects will be implanted with OSSIX Bone during sinus elevation surgery

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that need sinus elevation

You may qualify if:

• 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.

You may not qualify if:

• 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 4.
• 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
• Alcoholics patients and/or drug addicts
• Patients with known collagen hypersensitivity.
• Patients with sensitivity to porcine-derived materials.
• History or malignant tumours of the maxillary sinus
• History of local radiation therapy

Sponsors & Collaborators

• Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo: lead

Study Sites (1)

Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Rome, Italy

Location

Study Officials

• Luigi Canullo, DDS, PhD

  Study site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Luigi Canullo, DDS, Ph.D

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: May 4, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)