What side effects are associated with this type of intervention?

Common treatments for dental implants, such as those studied in the PrimeTaper Implant trial, include surgical placement and follow-up care to ensure osseointegration. Known side effects of these treatments can include infection at the implant site, implant failure, nerve damage leading to numbness or pain, and peri-implantitis, which is inflammation around the implant. Proper post-operative care and monitoring are essential to mitigate these risks.

What prior FDA approvals exist?

The FDA has approved various treatments and devices aimed at improving osseointegration for dental and orthopedic implants. These include different types of dental implants, such as titanium and zirconia implants, which are known for their biocompatibility and ability to integrate with bone. Additionally, bone graft materials and growth factors like bone morphogenetic proteins (BMPs) have been approved to enhance bone regeneration and support implant stability. While specific details about the PrimeTaper Implant are not provided, these approved treatments share the common goal of improving implant success through better osseointegration.

What other types of research exist?

Promising alternatives to the PrimeTaper Implant for 2024 include: 1) Zirconia Implants, known for their biocompatibility and aesthetic advantages; 2) 3D-Printed Implants, which offer personalized fit and faster osseointegration; 3) Bioactive Coatings, such as hydroxyapatite or growth factors, to enhance bone integration; and 4) Smart Implants with embedded sensors for real-time monitoring of implant health and osseointegration.

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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

No Placebo-Only Group

Summary

This trial tests the PrimeTaper dental implant, which is used to replace missing teeth by inserting it into the jawbone. The study focuses on patients needing dental implants and checks if the implant stays in place and works well over time.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ permanent restoration (baseline), and 1, 2, 3, 4, and 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Implants that Survived 1 year after Permanent Restoration

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PrimeTaper EV ImplantExperimental Treatment1 Intervention

All subjects will receive 1 PrimeTaper EV implant, UDI 0739253224012WR

0 / 9Eligibility criteria met

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.