Evaluating the PrimeTaper EV Implant for 5 Years

Implant Clinical Trial

Official title: An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Extraction Sockets and Healed Ridges - A 5-year Follow-up.

Status Not yet recruiting

Clinical Trial Summary

The purpose of the study is to evaluate the PrimeTaper's implant survival rate 1 year after permanent restoration (PR). After being identified as being eligible for the study (i.e., via screening and pre-planning surgical visits), subjects will have the PrimeTaper implant placed with a post-op check-up 1-2 weeks later, as well an impression visit in order to develop the permanent restoration. Furthermore, the permanent restoration will be placed no more than 6 months beyond the implant placement visit. After the permanent restoration, there will be follow-up visits at: (i) 6 months, (ii) 1 year, (iii) 2 years, (iv) 3 years, (v) 4 years, and (vi) 5 years.

Clinical Trial Description

The primary objective is to evaluate implant survival rate 1 year after permanent restoration (PR) (i.e., implant in place 1 year after PR, Yes/No). Secondary objectives are to evaluate: (i) implant survival rate 2, 3, 4, and 5 years after PR, (ii) implant stability at implant placement and at PR, (iii) insertion torque value and torque build-up at implant placement, (iv) the surgeon's perception of implant stability and confidence at implant placement, (v) maintenance of marginal bone levels (MBL), (vi) condition of the peri-implant mucosa (i.e., bleeding on probing (BoP), probing pocket depth (PPD), and plaque), and (vii) implant success. Furthermore, the safety objective of the investigation is to evaluate the safety of the PrimeTaper EV implant by assessing occurrence and severity of adverse events (i.e., evaluate reported Adverse Events (AEs), Device Deficiencies (DDs) and Adverse Device Effects (ADEs).

The null hypothesis is that at 1 year after PR, the implant will have survived in less than or equal to 89% of the subjects. Therefore, the study can test the alternative hypothesis that at 1 year after PR, the implant will have survived in greater than 89% of the subjects. ;

Related Conditions & MeSH terms

• Implant

• NCT number: NCT05387421
• Study type: Interventional
• Source: University of Iowa
• Contact: Christopher Barwacz, DDS
• Phone: 3193843002
• Email: chris-barwacz@uiowa.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Completion date: July 2028