PrimeTaper EV Implant for Implants

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa, Iowa City, IA
Implants
PrimeTaper EV Implant - Device
Eligibility
18+
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Permanent Restoration (baseline), and 1, 2, 3, 4, and 5 years

Year 1
Rate of Implants that Survived 1 year after Permanent Restoration
Year 5
Rate of Implants that Survived at 2, 3, 4 and 5 years after Permanent Restoration
During Implant Placement Procedure
Insertion Torque Value at implant placement.
During Implant Placement Procedure and During Permanent Restoration (baseline)
Implant stability at implant placement and at Permanent Restoration
Immediately After Implant Placement Procedure
The surgeon's perception of implant stability and confidence at implant placement.
Year 5
Condition of the periimplant mucosa - bleeding on probing (BoP)
Condition of the periimplant mucosa - plaque
Condition of the periimplant mucosa - probing pocket depth (PPD)
Year 5
Implant success (adapted Albrektsson et al 1986).
Year 5
Maintenance of Marginal Bone Levels (MBL)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

PrimeTaper EV Implant
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: PrimeTaper EV Implant · No Placebo Group · N/A

PrimeTaper EV Implant
Device
Experimental Group · 1 Intervention: PrimeTaper EV Implant · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: permanent restoration (baseline), and 1, 2, 3, 4, and 5 years

Trial Background

Prof. Christopher Barwacz, Associate Professor
Principal Investigator
University of Iowa
Closest Location: University of Iowa · Iowa City, IA
Photo of University of Iowa  1Photo of University of Iowa  2Photo of University of Iowa  3
1993First Recorded Clinical Trial
1 TrialsResearching Implants
447 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to sign and date the informed consent form and willing to attend 11 study visits over the next 5.
An adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally.
You must be fluent in speaking, reading, and comprehending English without need for a translator.
You must be able to pay for the following: $1300 for final crown, $15 for chlorhexidine mouthwash, and if applicable, $200 for tooth extraction and $600 for bone grafting.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.