PrimeTaper EV Implant for Dental Implants

Overseen By Christopher Barwacz, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Corticosteroids, Bisphosphonates, Monoclonal antibodies, others

Disqualifiers: Uncontrolled diabetes, Recent myocardial infarction, Severe liver dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using medications like corticosteroids, bisphosphonates, or other drugs that could affect healing, you may not be eligible to participate.

Is the PrimeTaper EV Implant safe for use in humans?

The safety of dental implants, including systems similar to PrimeTaper EV, has been evaluated in studies and through FDA reports. These evaluations often involve monitoring adverse events (unwanted effects) and long-term success rates, with some studies showing high success rates over several years. ^{1 2 3 4 5}

How is the PrimeTaper EV Implant treatment different from other dental implant treatments?

The PrimeTaper EV Implant is unique because it focuses on osseointegration, where the implant surface directly connects with the bone without any intervening tissue, which is crucial for stability and long-term success. Unlike traditional implants that may not fully integrate with the surrounding bone, this approach aims to create a more natural and durable connection. ^{6 7 8 9 10}

Research Team

Christopher Barwacz, Dr

Principal Investigator

University of Iowa

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to sign and date the informed consent form and willing to attend 11 study visits over the next 5.5 years

Must be fluent in speaking, reading, and comprehending English without need for a translator

Deemed by the investigator as likely to present with an initially stable implant situation

Exclusion Criteria

Previous enrollment in the present clinical investigation

Unable or unwilling to return for follow-up visits for a period of 5 years

Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Implant Placement

PrimeTaper implant is placed with post-op check-up and impression visit for permanent restoration

1-2 weeks

2 visits (in-person)

Permanent Restoration

Permanent restoration is placed no more than 6 months after implant placement

Up to 6 months

1 visit (in-person)

Follow-up

Participants are monitored for implant survival and condition of peri-implant mucosa

5 years

6 visits (in-person) at 6 months, 1, 2, 3, 4, and 5 years

Treatment Details

Interventions

• PrimeTaper EV Implant

Trial Overview 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.

Participant Groups

Group I: PrimeTaper EV Implant Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Findings from Research

From 1996 to 2011, there were 28,046 adverse event reports related to dental devices in the MAUDE database, with 53.5% of these reports concerning endosseous implants, highlighting a significant area of concern in dental device safety.

Among the reported adverse events, there were 66 death reports associated with dental devices, although many lacked sufficient information to confirm the circumstances, indicating a need for better reporting and monitoring systems in dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database. Hebballi, NB., Ramoni, R., Kalenderian, E., et al.[2021]

During a study analyzing dental device adverse events from August 1996 to June 1999, 28,555 reports (10.5% of total) were related to dental devices, with the majority involving injuries (64.4%) and a small number of deaths (0.007%).

Endosseous implants were the most frequently reported dental devices, accounting for over 90% of the reports, highlighting the importance of monitoring these devices for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental device-associated problems: an analysis of FDA postmarket surveillance data. Fuller, J., Parmentier, C.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a novel dental implant system as single implants under immediate loading conditions - 4-month post-loading results from a multicentre randomised controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The CE mark for implantable medical devices. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A 10-year multicenter retrospective clinical study of 1715 implants placed with the edentulous ridge expansion technique. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Dental device-associated problems: an analysis of FDA postmarket surveillance data. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Ligaplants: Uprising Regimen in the Glebe of Implant Dentistry. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

Immediate vs. early loading of SLA implants in the posterior mandible: 5-year results of randomized controlled clinical trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Astra Tech Single-Tooth Implant System: a report on 27 consecutively placed and restored implants. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

A prospective multicenter evaluation of 1,583 3i implants: 1- to 5-year data. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

MkII--a modified self-tapping Brånemark implant: 3-year results of a controlled prospective pilot study. [2004]