Active not recruitingNAINTERVENTIONAL

A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration

This study is testing a new system called Acuris™ for replacing a single missing tooth. Usually, a crown (the visible part of the tooth) is attached to an implant using cement or tiny screws. However, the Acuris™ system uses a unique friction-based connection, meaning it simply clicks into place without the need for these traditional methods. The main goal of this research is to see how well these new crowns stay in place and function over one year. By understanding this, we hope to find a more reliable and patient-friendly way to restore single missing teeth, potentially making the process simpler and improving long-term success for people needing dental implants.

At a glance

Status

Active not recruiting

Phase

Sponsor

Dentsply Sirona Implants and Consumables

Enrolment target

160

Start

30 Jul 2019

Estimated completion

30 Jun 2027

Jaw, Edentulous, Partially

Results

Results from this study

Posted March 2025

Results have been published for this study.

Primary outcome

Prosthetic Survival

Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment. Prosthetic survival will be categorized as No/Yes. It will be categorized as "Yes" if all of the following criteria are fulfilled: * Permanent restoration is remaining in situ. * No loss of conometric retention between abutment and final cap. * No fracture of abutment. * No loss of abutment.

Full results on the registry

What is this study about?

Imagine you need to replace a single missing tooth with an implant. After the implant is placed in your jawbone, a crown (the part that looks like a natural tooth) needs to be attached. Traditionally, this crown is either glued on with special cement or secured with a small screw. This study is looking at a brand new method called the Acuris™ conometric concept.

Instead of cement or screws, the Acuris™ system uses a clever 'friction' connection. Think of it like two perfectly fitting puzzle pieces that hold together tightly without any extra adhesive. The researchers want to find out how well these crowns stay put and work for people over a year. They are particularly interested in seeing how successful this new attachment method is in everyday use.

This research is important because finding easier and more reliable ways to attach crowns could lead to better long-term results for people with dental implants. If this new system proves effective, it might mean fewer complications and a more straightforward process for patients in the future.

Key takeaways

It's about a new way to attach single tooth crowns without cement or screws.
The study wants to see how well these new crowns last over one year.
It could offer a simpler, potentially better way to restore missing teeth.
Participation involves receiving an implant and attending check-ups over five years.
You must meet specific health and dental requirements to be eligible.

Who may be eligible?

You might be able to join this study if you are between 18 and 75 years old and need one dental implant to replace a single missing tooth between certain positions in your upper or lower jaw. You also need to have healthy natural teeth or existing implants on either side of where the new implant will go. If the missing tooth is at the very back (a second molar), it's okay for you not to have a tooth behind it.

There are also some reasons why you wouldn't be able to join. For example, if you have certain existing health conditions like uncontrolled diabetes, or if you've recently had radiation therapy in your head or neck. You also can't be taking certain medications like strong steroids or some bone strengthening drugs. You must be able to attend all follow-up appointments for five years.

It's important that you understand what the study involves and are happy to take part. You also shouldn't be participating in another clinical study right now, or have done so in the last six months, if it might affect this study.

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 just one dental implant to replace a single missing tooth?
Are you generally in good health and not currently taking certain medications?
Are you able to attend follow-up appointments for five years?
Have you read and understood what taking part in the study means?

Answer every question to see your result.

What does participation involve?

If you take part, you'll receive a dental implant and a crown using the new Acuris™ system. The study will mainly involve a series of check-ups over one year to see how well the crown is staying in place. You will need to attend follow-up visits for a total of five years to allow the researchers to keep track of your progress. The specific number of visits and tests will be explained in detail by the study team, but typically, these studies involve regular dental examinations and potentially X-rays. You'll also be asked to report any problems or concerns you might have with your new tooth.

Potential risks and benefits

Taking part in this study could mean you receive a new dental crown with a potentially innovative attachment method without the need for cement or screws. However, as with any medical procedure, there are potential risks, such as general risks associated with dental implant surgery, like infection or discomfort. Since this is a new method, its long-term success is still being evaluated. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

University of Illinois College of Dentistry
Verified postcode
Chicago, United States
Implant & Prosthodontic Associates
Verified postcode
Oklahoma City, United States
Cholakis Dental Group
Verified postcode
Winnipeg, Canada
Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH
Verified postcode
Ludwigshafen, Germany
Studio Toia
Verified postcode
Busto Arsizio, Italy
Clínica Dental Broseta
Verified postcode
Cheste, Spain
Clinica Dental Antuña de Alaiz SL
Verified postcode
Oviedo, Spain
Ten Dental
Verified postcode
London, United Kingdom
The Implant Experts LTD
Verified postcode
Maidstone, United Kingdom

Common questions

What is Acuris™?

Acuris™ is a new way to attach a dental crown to an implant using a special friction-based connection, rather than cement or screws.

Why is this study being done?

The study aims to see how well Acuris™ crowns perform and stay in place over one year, to evaluate if this new method is a good option for replacing missing teeth.

Who can join the study?

Adults aged 18-75 who need a single dental implant in specific positions and meet other health requirements may be eligible.

How long will I be involved?

You will be followed for a full year for the main part of the study, with additional follow-up visits for a total period of five years.

What if I change my mind?

You have the right to leave the study at any time, for any reason, without affecting your medical care.