PrimeTaper EV Implant for Missing Teeth Restoration

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

138 Participants Needed

Trial Summary

What is the purpose of this trial?

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 jawbone and acts like a root for the new tooth. Researchers will check after some time to see if the implant is still working well.

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 data supports the effectiveness of the PrimeTaper EV Implant treatment for missing teeth restoration?

Research on similar implant systems, like the Astra Tech Single-Tooth Implant System, shows high patient satisfaction and minimal complications over time, suggesting that implant treatments can be effective for tooth replacement. Additionally, studies on tapered implants in the aesthetic region and posterior dental areas indicate successful outcomes in terms of stability and aesthetics, which supports the potential effectiveness of the PrimeTaper EV Implant. ^{1 2 3 4 5}

Is the PrimeTaper EV Implant safe for humans?

The Astra Tech Single-Tooth Implant System, which is similar to the PrimeTaper EV Implant, has shown no recorded fixture failures and insignificant bone loss over time, indicating it is generally safe for humans. ^{4 6 7 8 9}

How is the PrimeTaper EV implant treatment different from other treatments for missing teeth restoration?

The PrimeTaper EV implant is unique because it is designed for immediate placement and loading, meaning it can be placed right after tooth extraction and quickly restored, reducing treatment time and surgical procedures. This approach helps maintain bone structure and aesthetics, which is particularly beneficial in areas where appearance is important. ^{4 10 11 12 13}

Research Team

Andy Temmerman, Prof.

Principal Investigator

KU Leuven

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. 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]

2. China pubmed.ncbi.nlm.nih.gov

[Clinical observation of the curative effect after 5-year follow-up of single tooth implant-supported restorations in the posterior region]. [2023]

3. China pubmed.ncbi.nlm.nih.gov

Clinical efficacy of simple taper retentive implants in immediate posterior dental implantation for 5-7 years. [2023]

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

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

5. Egypt pubmed.ncbi.nlm.nih.gov

Immediate Placement and Restoration of a New Tapered Implant System in the Aesthetic Region: A Report of Three Cases. [2022]

6. Iran pubmed.ncbi.nlm.nih.gov

Radiographic Vertical Bone Loss Evaluation around Dental Implants Following One Year of Functional Loading. [2021]

7. 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]

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

Clinical and Radiographic Evaluation of OsseoSpeed EV Implants. [2023]

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

A 5-year multicenter study on implant-supported single crown restorations. [2022]

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

Immediate provisional restoration of an implant placed in a fresh primary maxillary canine extraction socket: a case report. [2011]

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

Cast titanium dental implants for the posterior mandible. [2013]

12. Spain pubmed.ncbi.nlm.nih.gov

Immediate placement of single implant simultaneously with immediate loading in a fresh socket associated to periapical infection: A clinical case report. [2020]

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

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