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OpenTrials
Completed

NCT Number: NCT04381455

Evaluation of OSSIX® Bone in Sinus Elevation

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

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OSSIX Bone

Device

subjects will be implanted with OSSIX Bone during sinus elevation surgery

Primary outcomes

  1. Difference in Bone height from baseline

    Time frame: 1 year

  2. Difference in bone volume

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Other

Registry information

Official study title

Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 8, 2020
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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