A prospective, observational, multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years.
This will be a prospective, observational, multicenter study. All implants will be placed in the maxilla or mandible. The patient will either have a temporary prosthesis placed (out of occlusion) immediately (during the same implant placement visit or within 48 hours) or have a temporary or definitive prosthesis placed between 3-16 weeks following implant. Final restorations for all enrolled patients will take place no later than 4 months following implant placement surgery. All restorations will utilize the full range of the ZimVie prosthetic systems. The implant system will be evaluated yearly for 2 years. Patients who are in need of treatment with dental implants in the maxilla and/or mandible. Those patients with tooth sites having prior failed implant(s) or in need of implant revisions, or in need of major bone grafting to be done at the time of implant placement surgery are not eligible for inclusion. A total of 62 implants, will be placed across all participating sites. It is anticipated to have 60 patients, although one patient may contribute more than 1 implant.
Study Type
OBSERVATIONAL
Enrollment
62
Treatment of tooth loss with TSX dental implants
Ohio State University
Columbus, Ohio, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGThe number of implants that reach integration success/ implant survival at 2 years; the number of implants reaching primary stability during placement
Integration success (survival) of the implant will be determined by lack of mobility, no declared pain, absence of radiolucency, absence of infection and reaching primary stability upon final placement of implant until 2 years later.
Time frame: 2 years
The change in bone level (crestal bone regression) measured and compared at various study visits for each study implant
Measurement of bone level changes around the implant up to the 2 year final study visit as compared to the initial level at baseline (implant placement)
Time frame: 2 years
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