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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dental implant, the PrimeTaper EV, to evaluate its stability one year after permanent fitting. It targets adults needing a dental implant between their back teeth (specifically in tooth positions 3-14 or 19-30) with a stable bite. Participants must attend several follow-up visits over the next five years and cover some costs, such as the final crown and mouthwash. The trial does not suit individuals with certain dental or health conditions that might affect healing, like uncontrolled gum disease or ongoing infections. As an unphased trial, it offers participants the chance to contribute to dental innovation and potentially benefit from advanced implant technology.

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.

What prior data suggests that the PrimeTaper EV Implant is safe for dental use?

Research has shown that the PrimeTaper EV Implant was safe in earlier studies. It uses the same connection as the Astra Tech Implant EV, a well-known component in dentistry. This connection has undergone safety and performance testing, suggesting it is generally well-tolerated by patients.

The implant consists of pure titanium, a material commonly used in medical devices due to its low likelihood of causing adverse reactions in the body. Additionally, preclinical studies have supported the safety of the PrimeTaper EV Implant.

It is important to note that dental implants, in general, have had some negative events reported over the years. However, this does not specifically reflect the safety of the PrimeTaper EV Implant, which was developed with careful attention to patient safety and comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PrimeTaper EV Implant is unique because it introduces a new design that aims to improve stability and integration with the jawbone, which are critical for the success of dental implants. Unlike traditional dental implants, which can sometimes fail due to inadequate integration, the PrimeTaper EV features a specially tapered shape that enhances initial stability and bone preservation. Researchers are excited about this treatment because it could lead to faster recovery times and more predictable long-term outcomes for patients needing dental implants.

What evidence suggests that the PrimeTaper EV Implant is effective for dental implants?

Research has shown that the PrimeTaper EV Implant performs effectively. In one study, 99% of the implants remained securely in place. Another study found high user satisfaction after three years. These findings indicate that the implant effectively replaces missing teeth and provides lasting results. Overall, the evidence supports the implant's reliability and success in real-world use. ^{6 7 8 9 10}

Who Is on the Research Team?

Christopher Barwacz, Dr

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/229787/clinical-and-radiographic-evaluation-of-dentsply-sirona-primetaper-implants/

Clinical and Radiographic Evaluation of Dentsply Sirona ... Overview. The DS Prime Taper EV dental implant system was recently launched on the implant market by Dentsply Sirona (York, PA, USA).

2. dentsplysirona.com dentsplysirona.com/en-us/company/news-and-press-release-detail-page.html/content/dam/master/news/en/business-units/implants/2024/dentsply-sirona-primetaper-ev-implant-achieves-high-success-rate-and-satisfaction-in-first-dental-clinical-registry-at-3-year-mark

Dentsply Sirona PrimeTaper EV Implant Achieves High ... Dentsply Sirona's PrimeTaper EV Implant Achieves High Success Rate and Satisfaction in First Dental Clinical Registry at 3-Year Mark.

3. dentistrytoday.com dentistrytoday.com/dentsply-sironas-primetaper-ev-implant-earns-99-survival-rate-in-real-world-study/

Dentsply Sirona's PrimeTaper EV Implant Earns 99% ... Dentsply Sirona's PrimeTaper EV Implant Earns 99% Survival Rate in Real-World Study · PrimeTaper EV Implant Demonstrates High Clinical ...

4. trial.medpath.com trial.medpath.com/clinical-trial/3dc11e980bd9ffc2/prime-taper-ev-implant-clinical-outcome

A 5 year follow-up | MedPath An open, prospective, multicenter investigation to evaluate the clinical outcome of PrimeTaper EV implant in extraction sockets and healed ...

5. withpower.com withpower.com/trial/phase-jaw-edentulous-3-2022-73ee0

PrimeTaper EV Implant for Missing Teeth Restoration The OsseoSpeed EV Implants demonstrated a high overall survival rate of 92.6% over a mean follow-up of 42.1 months, with 78% of implants showing no marginal ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K210610.pdf

Dentsply Sirona, Inc. Rebecca Sporer Regulatory Affairs ... The proposed PrimeTaper EV Dental Implants are endosseous dental implants, which are manufactured from commercially pure titanium (Grade 4). The implant surface ...

7. dentsplysirona.com dentsplysirona.com/services/asset/download?path=/content/dam/master/product-procedure-brand-categories/implant-dentistry/collateral-marketing-product/clinical-and-science-support/document/32672783-usx-poster_ongoing-clinical-research-program-on-prime-taper-ev-implant/IMP-Poster-Ongoing-Clinical-Research-Program-on-Prime-Taper-EV-implant-32672783-USX-2309.pdf

A clinical study to evaluate the PrimeTaper EV Implant in ... The implant-abutment connection is the same as the well established Astra Tech Implant EV. Pre-clinical data for PrimeTaper EV proves the safety and performance.

8. withpower.com withpower.com/trial/phase-implants-6-2022-3b50f

PrimeTaper EV Implant for Dental Implants 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 ...

9. workflows.orderdigitalsolutions.com workflows.orderdigitalsolutions.com/pdf/DS%20PrimeTaper%20Surgical%20manual.pdf

32672260-USX-2202 PrimeTaper Surgical manual.indd The implant site is prepared in accordance with the drilling protocol to ensure simple and safe implant ... For correct placement of the PrimeTaper EV implant, ...

10. dentsplysirona.com dentsplysirona.com/en-us/discover/discover-by-brand/ds-primetaper.html

DS PrimeTaper Implant System It has a progressive thread design that enables it to quickly cut and engage with the bone. This allows for immediate function and shorter procedure times.