Status:
COMPLETED
Evaluation of OSSIX® Bone in Sinus Elevation
Lead Sponsor:
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Conditions:
Maxillary Sinus Floor Augmentation
Eligibility:
All Genders
30-80 years
Brief Summary
A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04381455
Start Date
May 4 2020
End Date
January 1 2022
Last Update
February 23 2022
Active Locations (1)
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1
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
Rome, Italy