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Implant

PrimeTaper EV Implant for Dental Implants

N/A
Waitlist Available
Led By Christopher Barwacz, DDS
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A stable occlusion (i.e., bite), i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture
Adult aged 18-75 years
Must not have
Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease
Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local requirements)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up permanent restoration (baseline), and 1, 2, 3, 4, and 5 years
Awards & highlights

Summary

This trial is designed to study the success of a new type of dental implant after one year.

Who is the study for?
Adults aged 18-75 needing a dental implant, with stable bite and adjacent teeth or crowns. Must be able to pay for associated costs, attend all study visits over 5.5 years, and understand English without a translator. Excluded if pregnant/breastfeeding, allergic to materials used in implants, have certain diseases or conditions affecting healing/osseointegration, are smokers or have substance abuse issues.Check my eligibility
What is being tested?
The trial is testing the PrimeTaper EV Implant's success rate over five years after permanent restoration placement. Participants will undergo implant surgery followed by several check-ups and impressions for the final crown within six months post-surgery.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of dental implants can include pain at the implant site, swelling of gums and face, bruising of skin and gums, minor bleeding, and possible infection at the implant site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My teeth or dental replacements fit together properly when I bite down.
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I am between 18 and 75 years old.
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I need a dental implant in the upper or lower front teeth area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have untreated dental issues like cavities or gum disease.
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I am not pregnant or breastfeeding.
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I am not on medications that could affect healing after surgery.
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I have a condition that could affect healing after surgery.
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I do not have any severe health issues that would prevent me from joining the study.
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I need bone regeneration in the area planned for an implant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~permanent restoration (baseline), and 1, 2, 3, 4, and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and permanent restoration (baseline), and 1, 2, 3, 4, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Implants that Survived 1 year after Permanent Restoration
Secondary outcome measures
Condition of the periimplant mucosa - bleeding on probing (BoP)
Condition of the periimplant mucosa - plaque
Condition of the periimplant mucosa - probing pocket depth (PPD)
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PrimeTaper EV ImplantExperimental Treatment1 Intervention
All subjects will receive 1 PrimeTaper EV implant, UDI 0739253224012WR

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for implants, particularly those focusing on osseointegration like the PrimeTaper Implant, involve pharmacological agents that enhance bone remodeling, control inflammation, and promote cell proliferation. These mechanisms are vital as they ensure the implant integrates well with the bone, providing stability and reducing the risk of implant failure. Effective osseointegration is crucial for the long-term success and functionality of the implant, ultimately improving patient outcomes.
Osseointegration Pharmacology: A Systematic Mapping Using Artificial Intelligence.

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
455 Previous Clinical Trials
882,110 Total Patients Enrolled
Christopher Barwacz, DDSPrincipal InvestigatorUniversity of Iowa
1 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

PrimeTaper EV Implant (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05387421 — N/A
Implants Research Study Groups: PrimeTaper EV Implant
Implants Clinical Trial 2023: PrimeTaper EV Implant Highlights & Side Effects. Trial Name: NCT05387421 — N/A
PrimeTaper EV Implant (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05387421 — N/A
Implants Patient Testimony for trial: Trial Name: NCT05387421 — N/A
~15 spots leftby Jul 2027