NCT00900822

Straumann Bone Ceramic Versus BioOss in Sinus Elevation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Jaw, Edentulous, Partially
• Alveolar Bone Loss

Interventions

Type	Name	Description
DEVICE	Straumann Bone Ceramic	Granules applied once during surgery
DEVICE	BioOss	Granules that are applied once during surgery

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-06-01
• Completion: 2008-12-01
• First posted: 2009-05-13
• Last updated: 2016-03-31
• Results posted: 2012-08-31

Locations

1 site across 1 country: Sweden