Maxillary Sinus Grafting With Bio-Oss or Straumann Bone Ceramic Followed by Delayed Placement of Straumann Dental Implants: A Comparative Histomorphometric and Clinical Study

Institut Straumann AG3 sites in 1 country48 target enrollmentJuly 2005

ConditionsTeeth Loss Bone Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Teeth Loss
Sponsor: Institut Straumann AG
Enrollment: 48
Locations: 3
Primary Endpoint: Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study was to test a clinically relevant non-inferiority of Straumann BoneCeramic treatment compared to Bio-Oss treatment 180 to 240 days after sinus grafting procedure.

Detailed Description

This is a prospective, controlled, randomised, multicenter study. The total study duration for each patient should be three years. In total 13 visits per patient are scheduled in this study. The study device Straumann Bone Ceramic is CE-marked. Height centers in Italy will participate.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

March 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut Straumann AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females were at least 18 years of age and not more than 70 years old
•A dental implant procedure was foreseen in the maxilla region corresponding to maxillary sinus
•Patients presented a bone defect in the sinus area, which needed a sinus floor elevation to place one or more dental implants
•The patients were unilaterally or bilaterally edentulous in the maxillary region corresponding to the sinuses
•Residual alveolar crest height of the lateral-posterior segments of the edentulous maxilla below the floor of the maxillary sinus was less than 8 mm and at least 3 mm, measured by CT scans. Furthermore, residual alveolar crest width should be at least in average 6 mm measured by the CT scans
•Patients were committed to the study
•Patients were healthy at time of surgery

Exclusion Criteria

•Medical conditions requiring prolonged use of steroids
•Standard blood test performed by the medical practitioner of the patient showing: leukocyte dysfunction and deficiencies
•Haemophilia, bleeding disorders or cumarin therapy
•History of neoplastic disease requiring the use of chemotherapy
•History of radiation therapy to the head and neck
•Patients with history of renal failure or chronic renal diseases
•Patients affected by chronic liver diseases
•Patients with severe or uncontrolled metabolic bone disorders
•Uncontrolled endocrine disorders (including diabetes)
•Current pregnancy at the time of recruitment

Outcomes

Primary Outcomes

Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement.

Time Frame: 180 to 240 days

Secondary Outcomes

Histomorphometric evaluation of the amount of new bone, soft tissue and remaining graft in the treatment, control and in a 1mm compartment 1mm close to the autogenous bone and the amount of new bone on contact with the graft.(180 to 240 days)
Clinical evaluation of peri implant soft tissue(3 years)
Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas(3 years)