Straumann Bone Ceramic Versus BioOss in Sinus Elevation
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.
Jaw, Edentulous, Partially
Alveolar Bone Loss
Device: Straumann Bone Ceramic
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Histologically Measured Bone to Implant Contact (BIC) [ Time Frame: 9 months after implant placement ] [ Designated as safety issue: No ]Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone
- Implant Survival Rate [ Time Frame: 12 months after loading the implant ] [ Designated as safety issue: No ]The percentage of implants remaining in the jaw.
- Implant Success Rate [ Time Frame: 12 months after loading the implant ] [ Designated as safety issue: No ]Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.
|Study Start Date:||November 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: Straumann Bone Ceramic
StraumannBone Ceramic is used as bone grafting material in sinus augmentation procedures
Device: Straumann Bone Ceramic
Granules applied once during surgery
Active Comparator: BioOss
BioOss is used as a bone grafting material in sinus augmentation procedure
Granules that are applied once during surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900822
|Dr Mats Hallman|
|Gävle, Sweden, 80187|
|Principal Investigator:||Mats Hallman, DDS, PhD||Clinic for oral maxillofacial surgery, Gävle hospital, Sweden|