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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Straumann BoneCeramic (500-1000 microns, 0.5g)
Bio-Oss spongiosa granules, size of particle 0.25-1 mm
Private Practice
Milan, Italy
University of Milan
Milan, Italy
Private Practice
Naples, Italy
Private Practice
Naples, Italy
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
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.
Time frame: 180 to 240 days
Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas
Time frame: 3 years
Clinical evaluation of peri implant soft tissue
Time frame: 3 years
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Private Practice
Pavia, Italy
Private Practice
Rome, Italy
Private Practice
Rome, Italy
Eastman Dental Hospital ASL RMA Roma
Rome, Italy