An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation (Romeo)
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|ClinicalTrials.gov Identifier: NCT00725049|
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : October 11, 2013
Last Update Posted : July 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Tooth Disease Partial Edentulism||Device: Dental Implant (Nanotite)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||February 2009|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725049
|Universidad Complutense de Madrid|
|Madrid, Spain, 28040|
|Principal Investigator:||Mariano A Sanz, MD, DDS||Universidad Complutense de Madrid|