An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation (Romeo)
This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed.
Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective, Multicenter, Randomized Multicenter Study of Short Implants Used to Obviate the Need for Sinus Augmentation: an Assessment of Clinical Outcomes and Resource Allocation.|
- Integration Success of Implant [ Time Frame: 3 years ]Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
- Cost Analysis [ Time Frame: 3 years ]
|Study Start Date:||February 2009|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Dental implant (Nanotite)
Dental implants of short length placed without sinus lifts
Device: Dental Implant (Nanotite)
Root form titanium dental implant
Other Name: Nanotite
No Intervention: Control group
Dental implants of standard length placed simultaneously with sinus augmentation
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725049
|Universidad Complutense de Madrid|
|Madrid, Spain, 28040|
|Principal Investigator:||Mariano A Sanz, MD, DDS||Universidad Complutense de Madrid|