Evaluation of OSSIX® Bone in Sinus Elevation

Maxillary Sinus Floor Augmentation Clinical Trial

Official title:

Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381455
• Other study ID #: DD-01
• Status: Completed
• Start date: May 4, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2022
• Source: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Maxillary Sinus Floor Augmentation

Intervention

Device:
• OSSIX Bone
subjects will be implanted with OSSIX Bone during sinus elevation surgery

Locations

Country	Name	City	State
Italy	Studio Odont.Associato Dr.P.Cicchese E L.Canullo	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Bone height from baseline		1 year
Primary	Difference in bone volume		1 year