Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
Study NCT ID:
NCT00713206
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2008-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
Sponsor:
ZimVie
Organization:
Study Overview
Official Title:
A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 (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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: