Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites|
- Integration Success of Implant [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis
- Crestal Bone Regression [ Time Frame: four years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||August 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
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.
|Università "G. d' Annunzio" Chieti-Pescara|
|Principal Investigator:||Sergio Caputi, DDS||Director del Dipartimento di Scienze Odontostomatologiche|