Teeth Loss, Bone Loss
Conditions
Keywords
maxillary sinus lift, Histomorphometric evaluation, bone graft, bone augmentation
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.
Interventions
DEVICEStraumann BoneCeramic
Straumann BoneCeramic (500-1000 microns, 0.5g)
DEVICEBio-Oss
Bio-Oss spongiosa granules, size of particle 0.25-1 mm
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 * Physical handicaps that would interfere with the ability to perform adequate oral hygiene * Use of any investigational drug or device within the 90 days period immediately prior to implant surgery on study day 0 * Alcoholism or chronically drug abuse causing systemic compromisation * Immunocompromised patients including patients infected with HIV * Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco * Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability Local
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological evaluation of the ratio between new bone and residual graft material at the implant site 180 to 240 days after graft-placement. | 180 to 240 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Evaluation of the survival and success rate of Straumann dental implants placed in the grafted areas | 3 years |
| Clinical evaluation of peri implant soft tissue | 3 years |
Countries
Italy
Outcome results
None listed