What is the mechanism of action of this treatment?

The most common treatments for a partially edentulous jaw include dental implants, such as the PrimeTaper EV implant. These implants act by integrating with the jawbone through a process called osseointegration, where the titanium post of the implant fuses with the bone, providing a stable and durable foundation for single tooth restorations. This stability is crucial for partially edentulous jaw patients as it ensures the restoration functions like a natural tooth, improving chewing efficiency, speech, and overall oral health. Additionally, implants help preserve the jawbone by preventing bone resorption that typically occurs after tooth loss.

What side effects are associated with this type of intervention?

The most common treatments for a partially edentulous jaw, such as dental implants like the PrimeTaper EV implant, can have several side effects. These include infection at the implant site, which can occur if bacteria enter during or after the procedure. Nerve damage is another potential side effect, leading to pain, numbness, or tingling in the natural teeth, gums, lips, or chin. Additionally, implant failure can occur if the implant does not properly integrate with the jawbone, which may necessitate removal and replacement. Other less common side effects include sinus problems for implants placed in the upper jaw and damage to surrounding structures such as blood vessels or teeth.

What prior FDA approvals exist?

The FDA has approved various dental implants for the treatment of partially edentulous jaws, providing stable and durable foundations for single tooth restorations. These implants, such as the PrimeTaper EV, are designed to integrate with the jawbone, offering long-term support and functionality. Other similar FDA-approved implants include the Straumann Dental Implant System and Nobel Biocare implants, which have demonstrated high success rates and predictable outcomes in clinical studies.

What other types of research exist?

Promising novel alternatives to the PrimeTaper EV implant for partially edentulous jaw patients include: 1) Zirconia dental implants, which offer excellent biocompatibility and aesthetic benefits. 2) Short dental implants, which are less invasive and suitable for patients with limited bone height. 3) 3D-printed custom implants, which provide a tailored fit and improved integration with the patient's anatomy. 4) Bioactive surface coatings, such as those using growth factors or antimicrobial agents, to enhance osseointegration and reduce infection risk.

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Dental Implant

PrimeTaper EV Implant for Missing Teeth Restoration

N/A

Waitlist Available

Led By Andy Temmerman, Prof.

Research Sponsored by Dentsply Sirona Implants

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A stable occlusion, 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

Florid infection

Hemorrhagic diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at date of implant placement (anticipated average 1 month after inclusion).

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

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 infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 75 years old.

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I am between 18 and 75 years old.

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My dental setup is stable with either natural teeth or dental work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active, severe infection.

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I have a bleeding disorder.

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I am not on medications that could affect healing after surgery.

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I have severe liver problems.

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I am not pregnant or breastfeeding.

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I do not have any health issues that could affect healing after surgery.

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I need bone regeneration in the area planned for an implant.

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I have had chemotherapy within the last 5 years.

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I have not had a heart attack in the last 3 months.

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I have or might have another type of cancer.

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I do not have untreated dental issues like cavities or gum disease.

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My diabetes is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after implant placement (anticipated average 1 month after inclusion).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after implant placement (anticipated average 1 month after inclusion).

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after implant placement (anticipated average 1 month after inclusion). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.

Secondary study objectives

Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.

Change of marginal bone level up to 5 years post permanent restoration compared to permanent restoration.

Change of probing pocket depth (PPD) in mm between permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.

+8 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: Single tooth restorationsExperimental Treatment1 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.

0 / 16Eligibility 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

The most common treatments for a partially edentulous jaw include dental implants, such as the PrimeTaper EV implant. These implants act by integrating with the jawbone through a process called osseointegration, where the titanium post of the implant fuses with the bone, providing a stable and durable foundation for single tooth restorations. This stability is crucial for partially edentulous jaw patients as it ensures the restoration functions like a natural tooth, improving chewing efficiency, speech, and overall oral health. Additionally, implants help preserve the jawbone by preventing bone resorption that typically occurs after tooth loss.

Study of the Clinical Efficiency of an Interdisciplinary Approach to the Treatment of Orofacial Pain and Temporomandibular Joint Disorders in Patients with Complete or Partial Edentulism.Treatment planning and sequence for implant therapy in a young adult with generalized aggressive periodontitis.