Active not recruitingOBSERVATIONAL

A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components

This research is studying different types of dental implants made by Nobel Biocare, specifically those using 'TiUltra' technology. The main goal is to see if these newer implants are just as good as older versions when it comes to how the bone around them changes over five years. This is important for the long-term success of the implants. The study involves 1000 participants who need either a single, multiple, or full set of tooth replacements. These participants will be treated at various dental clinics and followed for five years after their new teeth are fitted. The study also looks at how long the implants and new teeth last, and the health of the surrounding gum tissue.

At a glance

Status

Active not recruiting

Sponsor

Nobel Biocare

Enrolment target

1,000

Start

26 May 2021

Estimated completion

31 May 2029

Marginal Bone Level Change

What is this study about?

This study is looking at several types of dental implants from a company called Nobel Biocare. These implants use a special surface technology called TiUltra. The researchers want to find out if these newer implants work as well as (or even better than) some of the older Nobel Biocare implants that have been used for many years.

The main thing they are measuring is how the bone around the implants changes over time. When you have a dental implant, it's important that the bone stays healthy around it to keep the implant firm and secure. This study will follow people for five years after they get their new teeth fitted to see these bone changes. They will also check how long the implants themselves last, how long the new artificial teeth (crowns, bridges, or dentures) last, and the overall health of the gums around the implants.

About 1000 people will take part in this study across various dental clinics. These participants will be people who need dental implants for one tooth, several teeth, or even a full set of teeth. They will be assigned to one of four groups, each receiving a different type of the new TiUltra implant. The type of implant given will depend on what type of restoration you need and what your dentist usually uses. Every participant will be carefully monitored for five years.

Key takeaways

Studies new 'TiUltra' dental implants from Nobel Biocare.
Mainly checks bone health around implants over 5 years.
Involves 1000 people needing dental implants for missing teeth.
Follows participants for five years after their permanent new teeth are fitted.
Also looks at how long implants and new teeth last, and gum health.

Who may be eligible?

To join this study, you would need to be between 18 and 65 years old and need dental implants for one or more missing teeth. It's important that you have enough healthy bone in your jaw for the implant and that you look after your teeth and gums well.

There are also certain reasons why you wouldn't be able to join. For instance, if you have certain medical conditions like uncontrolled diabetes or if you smoke a lot (more than 10 cigarettes a day). If you've had certain cancer treatments in your head or neck, or if you're pregnant or breastfeeding, you also wouldn't be able to take part.

Your dentist would check all these things carefully to see if this study is suitable for you.

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 65 years old?
Do you need a dental implant for missing teeth?
Do you have enough healthy jawbone for an implant?
Do you practice good oral hygiene (brushing and cleaning your teeth well)?
Do you NOT smoke more than 10 cigarettes a day?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive one of four specific types of dental implants and the corresponding new prosthetic teeth. The type you get depends on your dental needs and what your clinic usually offers. You’ll be followed for five years after your final prosthetic teeth are fitted. During this time, you will have regular check-ups at 1 year, 3 years, and 5 years, where the dental team will take X-rays to measure bone changes and check the health of your gums. There won't be any specific medication provided as part of the study; it focuses on the implants themselves. The total duration of your involvement in the study will be five years from when your final new teeth are placed.

Potential risks and benefits

Participating in this study means you would receive dental implant treatment, which for some may be a benefit by addressing missing teeth. You would also be contributing to important research that helps dentists understand dental implants better. As with any medical procedure, there are potential risks associated with dental implant surgery, such as infection, pain, or discomfort, although these are usually manageable. The study also involves X-rays, which carry a small amount of radiation exposure. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual dental care.

Locations (32)

Madison Prosthodontics
Verified postcode
Madison, United States
Northwest Oral and Maxillofacial Surgery
Verified postcode
Arlington Heights, United States
Midwest Dental Implantology
City only
Saint Charles, United States
New York Center for Orthognathic and Maxillofacial Surgery
Verified postcode
New York, United States
Periodontal Associates
Verified postcode
Tualatin, United States
Dentartisans Pty ltd
Verified postcode
Pyrmont, Australia
Bc Prosthodontics
Verified postcode
West Perth, Australia
Melbourne Dental School The University of Melbourne
Verified postcode
Melbourne, Australia
Akademie für orale Implantologie GmbH & Co
Verified postcode
Vienna, Austria
Implantologie und Ästhetische Zahnheilkunde
Verified postcode
Vienna, Austria
Herning Implantat Center
Verified postcode
Herning, Denmark
Dental Center Helmiäinen
Verified postcode
Tampere, Finland

Common questions

What is a 'TiUltra' implant?

It's a type of dental implant made by Nobel Biocare that has a special surface technology to help it integrate with your bone.

What does 'marginal bone level change' mean?

It refers to how much the bone around your dental implant changes over time, which is important for the implant's stability.

How long will I be in the study?

You will be followed for five years after your new prosthetic teeth are permanently put in place.

Will I get to choose my implant type?

No, the type of implant you receive will depend on your dental needs and standard practice at your clinic, not a random choice.

Is this study suitable for people with diabetes?

Only if your diabetes is well-controlled. Uncontrolled diabetes (with a known A1c level above 8%) would prevent your participation.