Active not recruitingNAINTERVENTIONAL

Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations

This study is looking at a new type of dental implant called the OmniTaper EV, made from titanium, a metal commonly used in dentistry. The aim is to see if this implant is safe, works well, and offers a good solution when someone has lost a single tooth. Researchers want to make sure it's as good as or better than existing implants. All parts used in the study are already approved for use and will be used as intended. If you join, you'll have several dental visits over about five and a half years, similar to normal dental care. The study is open to men and women aged 18 to 75 and is taking place at six clinics in Germany, the UK, and Switzerland. You can choose to leave the study at any time.

At a glance

Status

Active not recruiting

Phase

Sponsor

Dentsply Sirona Implants and Consumables

Enrolment target

139

Start

22 Sep 2022

Estimated completion

31 Jan 2029

Jaw, Edentulous

What is this study about?

This study is checking out a new dental implant called the OmniTaper EV. Imagine a dental implant as a small screw that's placed into your jawbone to hold a replacement tooth. This new implant is an updated version of implants that are already out there. It's made from titanium, a material widely used in dental implants for over 40 years because it's very safe and gets along well with your body.

The main goal of this study, supported by the company Dentsply Sirona, is to make sure this new OmniTaper EV implant is safe to use and works as it should when replacing a single missing tooth. They want to confirm it's effective and functions properly, giving people a stable, natural-feeling replacement tooth. All the parts used in this study are already approved for dental use within Europe and will be placed using standard dental techniques.

Your participation is completely up to you, and you can decide to stop at any point without needing to explain why. Your decision won't affect any future dental care you receive. The study will involve around 137 people in total across different clinics in Europe, including the UK.

Key takeaways

New dental implant called OmniTaper EV is being tested.
Aims to replace a single missing tooth safely and effectively.
Made from titanium, a proven dental material.
Involves dental visits over about five and a half years.
All procedures are standard dental care; no extra experimental steps.
You can choose to leave the study at any time.

Who may be eligible?

To be considered for this study, you need to be between 18 and 75 years old and require a single dental implant in a specific area of your mouth (not including your very back molar teeth). You also need to have good general oral health and be prepared for your new implant to be stable right from the start.

There are also some requirements about your other teeth: you should have a stable bite (how your upper and lower teeth meet), whether that's from your natural teeth, crowns, or dentures. Importantly, you should also have a tooth or another implant next to where the new implant will go. However, if the implant is for your first back tooth, it's okay if there's no tooth right behind it.

You wouldn't be able to join if you have a known allergy to titanium or stainless steel, or if you have certain untreated dental problems like severe tooth decay or gum disease. Other reasons you might not be suitable include uncontrolled teeth grinding, needing a specific type of bone grafting where the implant will be placed, or having certain health conditions or taking medications that could affect healing or how the implant settles into your bone.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you need a single dental implant in a specific area (not a back molar)?
Do you have good overall dental health?
Are you able to attend follow-up dental appointments for up to five years?
Do you have no known allergy to titanium or stainless steel?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have several appointments over about five and a half years. This includes the initial visits for the implant placement and then follow-up appointments 6 months later, and then once a year for up to five years after your permanent crown is fitted. These visits and procedures are just like the care you'd get as standard for a dental implant; nothing extra will be done just for the research itself. Depending on your specific situation or how you heal, you might need a few extra visits. You will only receive one study implant if you participate.

Potential risks and benefits

Potential benefits of taking part include receiving a new dental implant, the OmniTaper EV, which is an advanced design, and having your dental care closely monitored by specialists. All components used are already approved for use. As with any dental procedure, there are potential risks, such as discomfort, swelling, or infection after the implant is placed, though these are typically managed with standard dental care. There's also a small risk the implant might not settle properly, which can happen with any dental implant. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your future dental treatment.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH
Verified postcode
Ludwigshafen, Germany
Private Clinic Schloss Schellenstein
Verified postcode
Olsberg, Germany
Kornmann Gerlach & Kollegen
Verified postcode
Oppenheim, Germany
Dr. med. dent. Alessandro Hellmuth Ponte
Verified postcode
Lugano, Switzerland
The Implant Experts
Verified postcode
Maidstone, United Kingdom
Birmingham Dental Hospital
Verified postcode
Birmingham, United Kingdom

Common questions

What is the OmniTaper EV implant?

It's a new design of dental implant, made from titanium, meant to replace a single missing tooth. The study is checking if it's safe and works well.

How long will I be in the study?

If you join, you'll have dental visits over a period of about five and a half years.

Will I get special treatment just for the study?

No, all the dental visits and procedures are the same as what you'd get during standard dental implant care. Nothing extra is done purely for the research.

Can I leave the study at any time?

Yes, your participation is voluntary. You can choose to leave the study at any point without needing to give a reason, and it won't affect your future treatment.

Will this implant replace multiple missing teeth?

No, this study is specifically for replacing a single missing tooth with one OmniTaper EV implant per participant.