A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the TSX Dental Implant System
ZimVie
Summary
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.
Description
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 year…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: 1. Patients at least 18 years of age 2. Patients for whom a decision has already been made to use a dental implant in an edentulous or immediately removed tooth site to be fully restored in the mandible or maxilla. 3. Site planned for immediate extraction and immediate restoration should have intact bony walls- Type I (as described in Special Procedures section) sockets as verified by CBCT and during surgery; Type II may be considered at the discretion of the treating clinician 4. Previously extracted sites (healed at least 3-4 months) 5. For all sites, presence of opposin…
Interventions
- DeviceTSX
Treatment of tooth loss with TSX dental implants
Locations (2)
- Ohio State UniversityColumbus, Ohio
- University of PennsylvaniaPhiladelphia, Pennsylvania