Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
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|ClinicalTrials.gov Identifier: NCT00713206|
Recruitment Status : Completed
First Posted : July 11, 2008
Results First Posted : October 11, 2013
Last Update Posted : August 30, 2017
This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation material. Control cases will be those where the sinus augmentation material is allowed four months of healing prior to NanoTite implant placement. In addition to implant performance, radiographic evidence of crestal bone regressive modeling will be used to evaluate differences between test and control cases.
Study (null) hypothesis: The implants placed into sinus augmentation sites at the time of grafting will have the same integration success and maintenance of integration as for the implants placed after four months of graft healing.
|Condition or disease||Intervention/treatment||Phase|
|Tooth Disease Partial Edentulism||Device: Dental Implant (Osseotite)||Not Applicable|
This will be a prospective, randomized-controlled, longitudinal study in which qualified patients with partial edentulism and thin maxillary ridges will have as part of their treatment at least one sinus ridge augmentation procedure and have their edentulism restored with an implant-supported short-span or long-span fixed bridge. Each patient may have up to two cases included in the study should they need bilateral sinus augmentation using unilateral bridge restorations on either side.
Each patient (or side if a bilateral case) will be randomly assigned to one of two groups: Treatment Group 1 (test) cases will have implants placed into the sinus cavity during the graft augmentation procedure. Treatment Group 2 (control) will have a sinus lift augmentation and implant placement into this area will take place after four months of graft healing. For both groups the implants will be submerged and allowed four months of healing before second stage surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: Dental implant (Osseotite)
Dental implants placed simultaneously with graft augmentation material.
Device: Dental Implant (Osseotite)
Root form titanium dental implant
Other Name: Osseotite
No Intervention: Control group
Dental implants placed into graft augmentation material that has four months to heal.
- Integration Success of Implant [ Time Frame: 3 year ]Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis
- Crestal Bone Regression [ Time Frame: four 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): NCT00713206
|Università "G. d' Annunzio" Chieti-Pescara|
|Principal Investigator:||Sergio Caputi, DDS||Director del Dipartimento di Scienze Odontostomatologiche|