Evaluation of OSSIX Bone in Sinus Elevation

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
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Updated on 19 February 2024
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Summary

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

Details
Condition Maxillary Sinus Floor Augmentation
Age 30years - 80years
Treatment OSSIX Bone
Clinical Study IdentifierNCT04381455
SponsorStudio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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