Evaluation of OSSIX® Bone in Sinus Elevation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-04

Study Completion Date

2022-01-01

Brief Summary

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

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Detailed Description

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Conditions

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Maxillary Sinus Floor Augmentation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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OSSIX Bone

subjects will be implanted with OSSIX Bone during sinus elevation surgery

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No