In patients with biltareral edentulous areas and resorbed alveolar processes in the maxilla a bilateral sinus augmentation with Bio-OssTM, CE certified (Geistlich Biomaterials, Wolhusen Switzerland) will be performed. In one side additionally autogenous stem cells, that were harvested from the proximal tibia 2 months before and cultivated over 2 months in vitro, will be applied in the test sinus. Histomorphometric analysis will be performed with Biopsies after 3 and 6 months.
Conditions
Interventions
Trade Name: BIO OSS TM (CE certified), Geistlich,
CH-6110 Wohlhusen
Pharmaceutical Form:
Sponsors
Department of Oral Surgery Dental School Med. Univ. Graz, Austria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy oral and medical status. Bilateral edentulous areas in the maxilla Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Agressive periodontitis, poor oral hygiene status, medical conditions that do not allow oral surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effect of autgenous MSC on bone healing in the maxilla;Secondary Objective: Evaluation of MSC on osseointegration of dental implants. Evaluation of donorsites for stem cells (tibia/maxilla/blood);Primary end point(s): The planned duration of the study is approx. 18 months and ends with the evaluation of osseointegration of the dental implants 9 months after implant insertion. | — |
Countries
Austria
Outcome results
None listed