NCT05264545

Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients

Prospective, Multicenter, Non-randomized, Controlled Clinical Study Utilizing Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: McGuire Institute · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

A 510k approved dental device for subjects requiring single or multiple tooth replacement with implants where immediate restoration/loading is preferred.

Detailed description

The rationale for this study is to provide scientific data on the clinical performance and patient reported outcomes of the PrimeTaper EV implant when utilizing non-guided vs guided surgical technique. The PrimeTaper EV implant has the OsseoSpeed surface, which is especially indicated for use in soft bone applications where implants with other surface treatments may be less effective. The main interests of this study are to assess the survival and the success rates of the implants supporting maxillary or mandibular fixed single or 2-fixture restorations after 1, 2, 3, 4 and 5 years in function

Conditions

• Partially Edentulous Maxilla or Mandible

Interventions

Type	Name	Description
DEVICE	PrimeTaper EV	The PrimeTaper EV Implant is a screw shaped dental implant with a defined surface achieved through grit blasting, followed by a process involving a treatment in diluted hydrofluoric acid. There is a conical connection between the implants and the abutments for a tight and stable connection.

Timeline

• Start date: 2022-03-22
• Primary completion: 2026-06-01
• Completion: 2026-10-01
• First posted: 2022-03-03
• Last updated: 2025-05-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study