PrimeTaper EV Implant for Missing Teeth Restoration

Not currently recruiting at 5 trial locations

Overseen By Mikaela Friberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dentsply Sirona Implants

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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a dental implant called PrimeTaper EV to assess its effectiveness for individuals needing a single tooth replacement. The research evaluates the success of these implants in remaining secure one year after permanent placement. It targets individuals with a missing tooth in specific mouth areas and a stable bite with adjacent teeth or implants. Participants should not have uncontrolled oral health issues such as severe cavities or gum disease. Those managing these conditions might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to dental research and potentially benefit from innovative implant technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications like corticosteroids or bisphosphonates, which could affect healing, you might need to stop them. It's best to discuss your specific medications with the trial team.

What prior data suggests that the PrimeTaper EV implant is safe for single tooth restorations?

Research shows that the PrimeTaper EV implant is designed for immediate use after tooth extraction, potentially making treatment faster and easier. Safety studies have evaluated the performance and longevity of these implants.

The PrimeTaper EV implant has undergone testing to ensure it meets design, function, and safety standards. These tests are crucial to confirm the implant's effectiveness in replacing missing teeth. Although specific safety details are not provided here, the thorough study of the implant suggests it is considered safe for human testing.

Generally, when a treatment reaches this level of study, early results have typically indicated it is reasonably safe for people. For those considering joining a clinical trial, this information can be reassuring, but discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PrimeTaper EV implant for restoring missing teeth because it offers a customizable approach with various diameter and length options, allowing for a better fit in different patients. Unlike traditional dental implants, which often have limited size variations, the PrimeTaper EV system provides more flexibility, potentially leading to improved comfort and integration with the jawbone. This tailored fit could result in quicker recovery times and higher success rates in restoring single missing teeth.

What evidence suggests that the PrimeTaper EV implant is effective for missing teeth restoration?

Research has shown that the PrimeTaper EV implant is highly effective for replacing missing teeth. One study found that the implant remained in place and functioned properly 99% of the time. Additionally, 96% of dentists reported a positive experience using it. These findings suggest that the PrimeTaper EV implant, which participants in this trial will receive for single tooth restorations, is a reliable choice for replacing a single tooth. Its high success rate indicates effectiveness in aiding chewing and enhancing overall dental health. ^{2 3 6 7 8}

Who Is on the Research Team?

Andy Temmerman, Prof.

Principal Investigator

KU Leuven

Are You a Good Fit for This Trial?

Adults aged 18-75 needing a single tooth implant in specific positions of the jaw, with stable occlusion and adjacent teeth or crowns. Excludes those allergic to titanium/stainless steel, with uncontrolled oral diseases, bruxism, immunosuppression, recent heavy treatments (chemo/radiation), substance abuse, severe systemic diseases or conditions affecting healing.

Inclusion Criteria

I have a tooth or implant next to the gap where my implant will go, except if it's for a first molar.

I have stable teeth or dental work that allows me to chew properly.

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

Exclusion Criteria

Current smoking/use of tobacco, including e-cigarettes

I do not have an active, severe infection.

I have not had radiation therapy in my head or neck area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implant Placement

Participants receive the PrimeTaper EV implant system for single tooth restorations

1 month

1 visit (in-person)

Permanent Restoration

Permanent restoration is completed and initial assessments are conducted

3 months after implant placement

1 visit (in-person)

Follow-up

Participants are monitored for implant success and survival, as well as adverse events

5 years

Multiple visits (in-person) at 1, 2, 3, 4, and 5 years post restoration

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 for single tooth restorations after one year. It aims to assess how well this particular dental implant survives and integrates into the jawbone over time.

How Is the Trial Designed?

Group I: Single tooth restorations Experimental Treatment 1 Intervention

A single, open-label group with patients in need of single tooth restorations will receive PrimeTaper EV implant system with diameters 3.6, 4.2, 4.8, 5.4 mm, and lengths 6.5, 8, 9, 11, 13, 15 and 17 mm.

Who Is Running the Clinical Trial?

Dentsply Sirona Implants

Lead Sponsor

Trials

63

Recruited

4,600+

Simon Campion

Dentsply Sirona Implants

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. David Ferguson

Dentsply Sirona Implants

Chief Medical Officer

MD from Harvard Medical School

Dentsply Sirona Implants and Consumables

Lead Sponsor

Trials

68

Recruited

4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Published Research Related to This Trial

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 bone loss at the end of the study.

Factors such as bruxism, history of periodontitis, and the diameter of the implants were identified as significant risk factors affecting implant survival, highlighting the importance of patient-specific considerations in dental implant procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Radiographic Evaluation of OsseoSpeed EV Implants. Esteve-Pardo, G., Esteve-Colomina, L.[2023]

Citations

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

PrimeTaper EV Implant for Missing Teeth Restoration This trial is studying how well the PrimeTaper EV dental implant works for people who need to replace one missing tooth. The implant is placed in the ...

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. Share.

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

Dentsply Sirona, Inc. Rebecca Sporer Regulatory Affairs ... The dental implants are intended to be surgically placed in the bone of the mandible and maxilla to replace missing teeth in order to restore chewing function.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05315414?keyword=%22Edentulous%22

San Mateo Clinical Trial Multicenter Study to Evaluate the ... The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after ...

5. 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% ... Despite this diversity, participants in the study report outstanding results, with 96% of clinicians rating their experience with the PrimeTaper ...

6. 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 ... More specifically, the aim is to evaluate short- and long-term survival and success rates as well as safety of the implant when used for single tooth ...

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

DS PrimeTaper Implant System A step-by-step tray system based on user preferences makes guided surgery with PrimeTaper EV Implant an essential component in any dental office. The ...

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

PrimeTaper EV Implant for Dental Implants 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 ...