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Clinical Trials/NCT01781221
NCT01781221
Unknown
Not Applicable

Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial

University Hospital of Cologne0 sites44 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height
Sponsor
University Hospital of Cologne
Enrollment
44
Primary Endpoint
Uneventful healing and histological bone formation
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
January 2018
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of Cologne
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone .
  • Men and women over the age of 18 years.
  • Patient has signed the Informed Consent.

Exclusion Criteria

  • Chronic steroid therapy.
  • Uncontrolled diabetes.
  • Cardiovascular disease.
  • Past irradiation of head and neck.
  • Maxillary sinus cysts.
  • Active chronic sinusitis.
  • Smoking more than ten cigarettes per day during the 3 months preceding this study .
  • Malignant disease in the 5 years preceding this study.
  • Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
  • Disease that compromise the immune system

Outcomes

Primary Outcomes

Uneventful healing and histological bone formation

Time Frame: 6 months following sinus floor augmentation

Secondary Outcomes

  • X-ray demonstration of volume - stable results(6 months following augmentation procedures.)
  • Equally high implant survival rates and crestal bone loss(After 1,2 years)

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