Active not recruitingOBSERVATIONAL

In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1

This study is investigating a new kind of dental implant, called TBR® Tissue Level Z1, for people who have lost some or all of their natural teeth. Losing teeth can affect how you chew, how your face looks, and your general confidence. Dental implants are a way to replace missing teeth and help keep your jawbone healthy. This research aims to understand how well these specific implants work over time in terms of safety and performance. The goal is to see if they can effectively restore chewing ability, improve the look of your smile, and ultimately enhance your quality of life by preventing bone loss and supporting your facial structure. The study will look at patients aged 18 and over who need dental implants.

At a glance

Status

Active not recruiting

Sponsor

Sudimplant SAS - Groupe TBR

Enrolment target

152

Start

23 Sep 2021

Estimated completion

01 Jul 2027

Edentulous Mouth

What is this study about?

When you lose teeth, it can have a big impact on your daily life. It can make eating difficult, change the way your face looks, and sometimes even affect your confidence and social life. Sadly, losing teeth can also lead to the jawbone shrinking over time, which can cause further problems.

Dental implants are a way to replace missing teeth. They are like small screws, usually made of titanium, that are placed into your jawbone. Once the implant has settled in, a new crown or bridge can be attached to it, giving you a strong, natural-looking replacement tooth. This particular study is looking into a new type of implant called the TBR® Tissue Level Z1. This implant aims to help prevent your jawbone from shrinking and keep your facial features looking natural.

The main goal of this study is to see how safe and effective these specific TBR® Tissue Level Z1 implants are. Researchers want to make sure they work well at helping people chew properly again, improving the appearance of their smile, and overall making a positive difference to their quality of life. Because implants are designed to become part of your jawbone, they can offer a long-lasting solution for missing teeth.

Key takeaways

This study is testing a new dental implant for missing teeth.
It aims to improve chewing, smile appearance, and quality of life.
Implants can help prevent jawbone loss.
Participation involves receiving the implant and attending follow-up checks.
You must be 18 or older and meet specific health criteria.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have stopped growing. You must also be missing some or all of your teeth and be planning to get these specific TBR® Tissue Level Z1 implants. If you previously had these implants placed before June 2011, you might also be able to join the study.

However, there are certain reasons why you wouldn't be able to take part. For example, if you are pregnant or breastfeeding, or if you have certain bone conditions affecting your head or neck. People taking specific medicines for osteoporosis (like bisphosphonates or denosumab) also cannot join. It's important that you have enough strong jawbone to support an implant and that your mouth is generally healthy. You must also be willing to take part and give your permission.

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 18 years old or older?
Are you missing some or all of your teeth?
Do you have enough healthy jawbone for an implant?
Are you not pregnant or breastfeeding?
Are you not taking specific osteoporosis medications like bisphosphonates or denosumab?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, the main part of it involves receiving the TBR® Tissue Level Z1 dental implant(s) as part of your standard dental treatment. This means you’ll undergo a dental procedure where the implant is carefully placed into your jawbone. Following this, there will be a period of time for the implant to heal and integrate with your bone. After this healing period, your dentist will attach the final replacement tooth or teeth to the implant.

The study will then involve regular check-ups to see how the implant is working over time. These check-ups will assess the safety and effectiveness of the implant, how well it's staying in place, and if it's helping with your chewing and overall comfort. The exact number and frequency of visits, as well as the total duration of your participation, would be fully explained by the study team. You won't be given any experimental medication, as this study is about the implant device itself. Your medical team will monitor your progress throughout the study period.

Potential risks and benefits

Taking part in this study could offer several benefits, such as regaining your ability to chew comfortably, improving the appearance of your smile, and helping to keep your jawbone healthy. However, all medical procedures carry some risks. These could include general risks associated with dental surgery, such as discomfort, swelling, infection, or problems with the implant healing. The study team will explain all potential risks in detail. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

Cabinet du Dr ALLOUCHE
Verified postcode
Montpellier, France

Common questions

What is a dental implant?

A dental implant is like a tiny screw, usually made of titanium, that replaces the root of a missing tooth. It's placed into your jawbone to support a new crown or bridge.

Why is this study important?

This study helps us understand how safe and effective a new type of dental implant, the TBR® Tissue Level Z1, is at improving chewing, appearance, and overall quality of life for people missing teeth.

Will I have to pay to be in the study?

The study aims to evaluate the implant’s performance. Any costs related to the implant procedure itself would be discussed with your dental provider, as this is typically considered a dental treatment.

How long will the study last?

The exact length of the study, including follow-up appointments, will be explained by the study team once you express interest. Implants are designed to be long-lasting, and studies often monitor their performance over several years.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your medical care.