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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
- Cost Analysis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|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
In this randomized study, patients needing restorations in the posterior maxilla will be randomly assigned to the short implant group (test) or the standard length and augmentation group (control). All implants will be placed using a two-stage approach with healing abutments placed at three months and temporary prosthesis at four months following implant and/ or sinus augmentation surgery. Time, materials, and efforts associated with treating test and control cases will be documented to allow an assessment of the costs incurred with each approach.
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|