Alveolar Bone Loss Clinical Trial
Official title:
Randomized, Controlled Clinical Study to Compare Bone Formation Around Micro-implants in the Maxilla After Sinus Floor Augmentation With Straumann Bone Ceramic or Bio-Oss in a Split Mouth Design
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not worse than BioOss.
Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there
is a need for bone augmentation in the posterior upper jaw. The bone grafting materials will
be placed into the sinus cavity,(a routine procedure), one material randomly at each side
and a micro-implant will be inserted simultaneously. 9 months later the micro-implant is
removed and a regular Straumann SLActive implant is inserted. The micro-implant is evaluated
histologically. The site is evaluated every 12 months for 3 years in regards to clinical
measurements. The study hypothesis is that the SBC is not worse than BioOss.
Study design: Prospective, randomized, open, controlled, single center, split mouth
Study population: 11 male and female patients at an age of between 18 and 80 years, affected
by edentulism of both lateral-posterior maxilla and presenting two pneumatized maxillary
sinuses and necessitating rehabilitation with implant-supported prostheses will be recruited
in the study and treated by means of maxillary sinus floor augmentation and delayed implant
placement.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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