Evaluation of OSSIX® Bone in Sinus Elevation

Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04381455

Enrollment

Registered

2020-05-08

Start date

2020-05-04

Completion date

2022-01-01

Last updated

2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Floor Augmentation

Brief summary

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

Interventions

DEVICEOSSIX Bone

subjects will be implanted with OSSIX Bone during sinus elevation surgery

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026