PrimeTaper EV implant for Jaw, Edentulous, Partially

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Jaw, Edentulous, Partially+1 More
PrimeTaper EV implant - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at how well the PrimeTaper EV implant works in single tooth restorations, specifically how long the implant lasts.

Eligible Conditions
  • Jaw, Edentulous, Partially

Treatment Effectiveness

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Immediately after implant placement (anticipated average 1 month after inclusion).

Year 5
Implant success, i.e., number of implants documented as successful at 1, 2, 3 and 5 years after permanent restoration.
Year 5
Implant survival, i.e. number of implants in place counted clinically, 2, 3, 4 and 5 years after permanent restoration.
Year 5
Dental Plaque
Month 1
Final insertion torque value for each implant at implant placement.
Maximum insertion torque value for each implant at implant placement.
Year 5
Change of marginal bone level up to 5 years post permanent restoration compared to permanent restoration.
Year 5
Change of probing pocket depth (PPD) in mm between permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
Presence of bleeding on probing (BoP), at permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
Month 3
Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.
Month 1
Investigator questionnaire for each investigational medical device after implant placement.
Month 3
Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.
Year 5
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.

Trial Safety

Trial Design

1 Treatment Group

Single tooth restorations
1 of 1
Experimental Treatment

137 Total Participants · 1 Treatment Group

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

Single tooth restorations
Device
Experimental Group · 1 Intervention: PrimeTaper EV implant · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after implant placement (anticipated average 1 month after inclusion).

Who is running the clinical trial?

Dentsply Sirona ImplantsLead Sponsor
62 Previous Clinical Trials
4,544 Total Patients Enrolled
13 Trials studying Jaw, Edentulous, Partially
1,074 Patients Enrolled for Jaw, Edentulous, Partially
Andy Temmerman, Prof.Principal InvestigatorKU Leuven

Eligibility Criteria

Age 18+ · All Participants · 6 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.
An adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 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.

Who else is applying?

What state do they live in?
Alabama100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Iowa100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%